MedDevREG AfriSummit

MedDevReg AfriSummit brings together National Regulatory Affairs Agencies and Industry to discuss Medical Device and iVD Regulations and Market access throughout Africa.

Effective regulatory frameworks, harmonized to international standards, are critical to expanding access to quality medical devices in low- and middle-income countries. A streamlined regulatory process across African nations would simplify this process for innovators seeking to bring medical devices to the African market, thereby increasing patient access to safe medical devices.

This two-day event provides a platform for discussion and collaboration for manufacturers and distributors to bring these life-changing devices to the continent.
MedDevReg AfriSummit will highlight the most important and relevant medical device and iVD regulations, through case studies, interactive presentations, and discussions.

Attendees will learn which regulatory strategy is applicable for their products in which
country in Africa.

VENUE

Grand Nile Tower – Cairo, Egypt

5-6 November

2024

50 SPEAKERS

Government & industry Speakers

200+ SEATS

Hurry up, register!

2023 SPEAKERS

MR. ABEBE ALAMNEH KASSAHUN

Position: Medicine Registration Expert - Ethiopian Food and Drug Authority (EFDA) & Vice Chairman -East African regulatory Affairs Professionals Association (EARAPA)
Categories: MedDev Speakers 2023, RA Speakers 2023

Abebe Alamneh Kassahun is a dedicated professional with a strong background in the field of medicine regulatory affairs. He holds a Bachelor’s degree in Pharmacy and a Master’s degree in Medicine Regulatory Affairs from Addis Ababa University.

Currently, Abebe serves as a Medicine Registration Expert at the Ethiopian Food and Drug Authority (EFDA), where he plays a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products in Ethiopia. With his expertise, he actively contributes to the regulatory processes involved in the registration and approval of medicines, ensuring compliance with national and international standards.

In addition to his role at EFDA, Abebe also holds the esteemed position of Vice Chairman at the East African Regulatory Affairs Professionals Association (EARAPA). As the Vice Chairman, he demonstrates exemplary leadership skills and actively participates in shaping the regulatory landscape within the East African region. Abebe collaborates with fellow professionals to develop harmonized regulatory frameworks, facilitate information exchange, and promote best practices in medicine regulation.

MR. ABEBE ALAMNEH KASSAHUN

Medicine Registration Expert - Ethiopian Food and Drug Authority (EFDA) & Vice Chairman -East African regulatory Affairs Professionals Association (EARAPA)

DR. MIRIAM BOLES

Position: HEAD OF CENTRAL ADMINISTRATION OF MEDICAL DEVICES - EGYPTIAN DRUG AUTHORITY (EDA)
Categories: MedDev Speakers 2023

Miriam Boles is the head of central administration of medical devices in the Egyptian drug authority. She holds a bachelor degree of pharmaceutical sciences from an established Egyptian university and a master degree in business administration from Arab Academy for Science, Technology & Maritime Transport, (AASTMT), where she specialized in supply chain.

Miriam worked for two decades in various positions in medical device regulatory governmental sector. Prior to her current role, Miriam began her career as medical devices registration reviewer, then senior reviewer, afterwards , director of medical devices unit.

From November 2020, Miriam became the head of central administration of medical devices.

Her goals in this role are to develop and implement strategic plans for premarket regulations of medical devices and IVDs in pursuit of EDA’s mission and vision of providing safe, and effective medical devices.

The most significant achievements that took place under her leadership :

  • Enhancing the localization of many medical devices and equipment.
  • Establishing an online platform (MeDevice) for automating administrative
  • workand electronic archiving.
  • Issuing guidelines to regulate all procedures related to premarket approvals, unique device identification and labelling requirements.
  • Developing a procedure to regulate the import and circulation of laboratory and diagnostic reagents for the first time in the Arab Republic of Egypt.
  • Unique device identification(UDI) was applied to all medical devices that are circulated in the local market .

Miriam Boles is an experienced hard worker driven by passion. She takes pride in providing the best possible achievements. She believes in team work, power of positivity, motivation by task, and interested in data analysis, problem solving beside her sustainable passion to be kept updated with medical devices and IVDs regulations all over the world.

DR. MIRIAM BOLES

HEAD OF CENTRAL ADMINISTRATION OF MEDICAL DEVICES - EGYPTIAN DRUG AUTHORITY (EDA)

DR. NOHA EL HARIRI

Position: GENERAL DIRECTOR OF THE GENERAL ADMINISTRATION OF MEDICAL DEVISES REGISTRATION - EGYPTIAN DRUG AUTHORITY (EDA)
Categories: MedDev Speakers 2023

Dr. Noha El-Hariri is the General director of the general administration of medical devises registration -Egyptian drug authority (EDA) since 2020 and until now.

In 2003 She had bachelor of clinical pharmacy with excellent grade with honor.

In 2019 She had  her MBA (master of business administration in health economics) with grade excellent with honor.

She worked in the central administration for pharmaceutical affairs since 2004 as inspector.

In 2011 she left the inspection department and joined the medical device department.

On 2019 the EDA was established and she was chosen among the cadres who were transferred from the ministry of health to join EDA and she was selected to be the general manager of general administration of medical device registration.

DR. NOHA EL HARIRI

GENERAL DIRECTOR OF THE GENERAL ADMINISTRATION OF MEDICAL DEVISES REGISTRATION - EGYPTIAN DRUG AUTHORITY (EDA)

DR. RANIA SOLIMAN

Position: GENERAL MANAGER, GENERAL ADMINISTRATION OF MARKET AUTHORIZATION OF MEDICAL DEVICES, - EGYPTIAN DRUG AUTHORITY (EDA)
Categories: MedDev Speakers 2023

Dr. Rania obtained her bachelor’s degree in pharmaceutical sciences from the Faculty of Pharmacy at Cairo University in 2005. During her undergraduate studies, she engaged in part-time work and summer internships at various pharmaceutical firms, factories, and pharmacies. Following her graduation, she fulfilled her mandatory government service with distinction, serving as a Validation Specialist from July 2006 to March 2007 and later as a Quality Auditor from March 2007 to March 2009.

Her journey continued in 2009 when she transitioned to the Central Administration of Pharmaceutical Affairs (CAPA). This organization, a pivotal entity under the Egyptian Ministry of Health, oversees a wide array of regulatory functions, including registration, pricing, inspection, importation, and licensing of all medical products. Dr. Rania commenced her role as a Medical Device Custom Release Specialist, with responsibilities that encompassed evaluating importation approvals, liaising with global notified bodies for quality verification, and collaborating with other departments to update importation guidelines.

Impressed by her organizational prowess, fluency in English, and remarkable presentation skills, her immediate supervisor recognized her talents. As a result, she was entrusted with the role of Rapporteur for the Specialized Committee on Importing Supplies and Medical Devices, as well as the responsibility of overseeing various scientific committees.

In her present capacity, Dr. Rania’s responsibilities are wide-ranging and crucial. She meticulously examines applications for import approvals, establishes trading regulations, approves importation plans, and leads specialized scientific committees. Her role involves interactions with high-level officials, including CAPA’s Director and the Assistant to the Minister of Health for Pharmaceutical Affairs, where she contributes to policy updates and registration rules for medical devices. Collaborating with the medical device pharmacovigilance department, she ensures post-marketing safety and efficacy through surveys and clinical questionnaires.

Dr. Rania’s achievements extend beyond the workplace. She has been selected to contribute to the formulation of Egyptian guidelines for medical devices, as well as to participate in the development of clinical trials protocols. Her dedication led her to represent her workplace in international events, such as the Arab Transfusion Medical Course and the First Arab Conference for Food, Drug, and Medical Devices.

Evidently, Dr. Rania is deeply committed to advancing healthcare policies. Her engagements with governmental bodies, parliament members, and international organizations like WHO demonstrate her role in shaping rules and regulations for medical device registration in Egypt. Notably, she anticipated a critical shortage of medical devices following currency devaluation and advocated for emergency measures to mitigate potential health crises.

Her pursuit of continuous improvement is evident through her participation in various programs, including Project Management, International Visitor Leadership, Total Quality Management, and ISO standards for medical devices. Now, in her mid-thirties, Dr. Rania holds a senior leadership position at CAPA, where she adeptly navigates her dual roles in pharmaceutical and civil service functions.

Outside of her professional commitments, Dr. Rania’s humanitarian spirit shines through her involvement in charity and social affairs. She dedicates her time and resources to support those in need and works passionately to empower women—an endeavor she holds close to her heart.

DR. RANIA SOLIMAN

GENERAL MANAGER, GENERAL ADMINISTRATION OF MARKET AUTHORIZATION OF MEDICAL DEVICES, - EGYPTIAN DRUG AUTHORITY (EDA)

Dr. Saida Foughalia Fridi

Position: Deputy Director of Scientific Documentary Evaluation of Medical Devices - The National Agency for Pharmaceutical Products (ANPP)
Categories: MedDev Speakers 2023

Doctor Saida Foughalia Fridi, Deputy Director of Scientific Documentary Evaluation of Medical Devices at the National Agency for Pharmaceutical Products (ANPP), and former head of medical device  vigilance at the National Center for Pharmacovigilance and Material Vigilance (CNPM).

Dr. Saida Foughalia Fridi

Deputy Director of Scientific Documentary Evaluation of Medical Devices - The National Agency for Pharmaceutical Products (ANPP)

MR. CHRISTIAN NATALIS KAPINGA

Position: Drug Registration Officer – Tanzania Medicines and Medical Devices Authority (TMDA)
Categories: MedDev Speakers 2023

He gained experience in regulation of both medicines, medical Devices, and invitro diagnostics specifically on Evaluation of dossiers for acquiring MA, conducting inspection of premises, conducting post marketing surveillance and vigilance, and conducting GMP inspection and quality audit against ISO 13485.

Christian has previously Worked as Supply Chain Advisor for PEPFAR HIV/AIDS Project at Bugando Medical Centre- A hospital in Eastern Northen part of Tanzania.

MR. CHRISTIAN NATALIS KAPINGA

Drug Registration Officer – Tanzania Medicines and Medical Devices Authority (TMDA)

Dr. Richard Tendayi Rukwata

Position: Director-General at the Medicines Control Authority of Zimbabwe.
Categories: MedDev Speakers 2023, RA Speakers 2023

Richard is a pharmacist with 26 years’ experience starting off his career in hospital pharmacy in the public sector.  He has spent the last 19 years in the regulatory profession in various capacities.  He is currently the Director-General at the Medicines Control Authority of Zimbabwe.

Dr. Richard Tendayi Rukwata

Director-General at the Medicines Control Authority of Zimbabwe.

Ms. Ofentse Ramokgopa

Position: Medical Devices & IVD Technical Officer (Compliance) - SAHPRA
Categories: MedDev Speakers 2023

Ofentse Ramokgopa is a pharmacist by profession who obtained her qualification from Nelson Mandela Metropolitan University, she is currently in pursuit of a master’s degree in pharmaceutical affairs at the university of the Witwatersrand with her research focus on advanced drug development. Her first exposure to medical devices was through community service at the former Medicines control Council (MCC) which is now The South Africa Health Products Regulatory Authority (SAHPRA).  Her experience includes wholesale, distribution, and warehousing. She currently holds a position as a medical device technical officer responsible for Licensing and Compliance at SAHPRA.

Ms. Ofentse Ramokgopa

Medical Devices & IVD Technical Officer (Compliance) - SAHPRA

Ms. Khanyisile Nkuku

Position: Medical Device Registration Officer - SAHPRA
Categories: MedDev Speakers 2023

Ms Khanyisile Nkuku is a Medical Device & IVD Registration Officer, she holds a Bachelor of Pharmacy degree from the University of Witwatersrand. She is currently completing her Master’s in pharmacy administration & Policy Regulations. She has experience and Knowledge in medical device registration, clinical trials regulation, law enforcement, licensing, post marketing surveillance, reliance, and good regulatory practice.

Ms. Khanyisile Nkuku

Medical Device Registration Officer - SAHPRA

MR. EMMANUEL NKRUMAH

Position: DIRECTOR FOR THE MEDICAL DEVICE, COSMETICS AND HOUSEHOLD CHEMICALS DIRECTORATE AT THE FOOD AND DRUGS AUTHORITY (FDA) – GHANA
Categories: MedDev Speakers 2023

Emmanuel Nkrumah is the Director for the Medical Device, Cosmetics and Household Chemicals Directorate at the Food and Drugs Authority (FDA), Ghana. He has been a regulatory officer for eighteen years with immense experience in Food, Drugs, Medical devices, Cosmetics and Household chemicals regulation.

 

Emmanuel holds a Bachelor’s degree in Biological Sciences from the Kwame Nkrumah University of Science and Technology, Kumasi and a Master’s degree in Pharmaceutical Sciences from the University of Greenwich, United Kingdom.

Emmanuel is a member of the Food and Drugs Authority’s GMP inspection team (as a GMP Lead inspector) and a member of the Drugs Product Registration Committee of the Food and Drugs Authority.

He is also a member of the Technical Committee (National committee) responsible for drafting standards for the Cosmetics and Household chemicals industry at the Ghana Standards Authority, and also the Ghana Society of Dermatology.

 

Emmanuel has a strong background in the regulation of medical devices, cosmetics and household chemicals in Ghana, and has been involved in the drafting of a number of policies for the regulation of the medical devices, cosmetics and household chemical industry in Ghana; and has represented Ghana on the international stage having delivered a presentation including Cosmetic Regulation in West Africa.

MR. EMMANUEL NKRUMAH

DIRECTOR FOR THE MEDICAL DEVICE, COSMETICS AND HOUSEHOLD CHEMICALS DIRECTORATE AT THE FOOD AND DRUGS AUTHORITY (FDA) – GHANA

Mr. Morad Ajan

Position: Head of Medical Device Unit. (Directorate of Medicine and Pharmacy - Morocco)
Categories: MedDev Speakers 2023

Mr. Morad Ajan

Head of Medical Device Unit. (Directorate of Medicine and Pharmacy - Morocco)

Ms. Kesego Moalosi

Position: Medical Devices Regulatory Officer - BoMRA (Botswana Medicines Regulatory Authority)
Categories: MedDev Speakers 2023

Ms. Kesego Moalosi is a goal-oriented professional with a background in medical devices. She holds a bachelor’s degree in biomedical and electrical Engineering from Carleton University, Canada, and a master’s degree in project management from Sunderland University as well as a RAPS Certificate on Medical Devices Regulatory Affairs.

Ms. Kesego gained her experience in medical devices on her previous roles where she served as a Biomedical Engineer at a government hospital in Botswana where she was mandated with servicing, repairing, and carrying out routine maintenance of major and minor medical equipment. She has also served as a Medical Devices Capital Equipment Supervisor for two years in a private sector in which one of her roles was setting up, conducting, and overseeing maintenance plans and maintenance programs of all capital equipment supplied by the company.

Currently Ms. Kesego holds a Medical Devices Regulatory Officer position at Botswana Medicines Regulatory Authority (BoMRA), where she plays a major role in ensuring safety, qualify and efficacy of medical devices. In her current role, she is involved in implementation of Medical Devices Regulatory Framework through assessment of medical devices (both human and animal) registration applications as well as through collaborating with other internal Departments in development and implementation of: Licensing, Inspection and Post Market Surveillance plan for medical devices including IVDs.

Ms. Kesego Moalosi

Medical Devices Regulatory Officer - BoMRA (Botswana Medicines Regulatory Authority)

Dr. Frank N Laban

Position: Principal Registration Officer - Zambia Medicines Regulatory Authority (ZAMRA)
Categories: MedDev Speakers 2023

Frank N Laban is a Pharmacist at the Zambia Medicines Regulatory Authority with 15 years of experience as a regulator in the area of medicines and medical devices regulation.

Currently Frank N Laban is the Principal Registration Officer overseeing marketing authorization activities around Allied Substances and Human Medicines in Zambia.

Frank holds a holder of a BPharm and is a candidate in Ms Pharmacy Administration and Policy

Dr. Frank N Laban

Principal Registration Officer - Zambia Medicines Regulatory Authority (ZAMRA)

Dr. Emil Ivan Mwikarago

Position: Department of Human Medicine and Device assessment & Registration, Division of Human Medicine, Assessment and Registration - Rwanda FDA 
Categories: MedDev Speakers 2023

My professional experience spans over a decade, during which I have held Technical and Management Positions. Notably, I served as the National Reference Laboratory Division Manager at Rwanda Biomedical Center, where I held senior positions. In this role, I was responsible for overseeing diagnostics and management of reference laboratory division and medical device performance evaluation procedures, providing technical reports to the Ministry of Health, and guiding diagnostic algorithm decisions for equipment and IVDs in the country. My areas of expertise include Research, Training, Mentorship, supervision, diagnostics, Field epidemiology, and public health mostly touching the big three diseases such as HIV, TB, Malaria and other blood borne pathogens including regulatory procedure for medical devices per world health organization guidelines. I have published scholarly articles on these topics with over 35 Publications in PubMed and Medline and google scholar.

In June 2021, I joined Rwanda Food and Drugs Authority as the Medical Device and IVDs Assessment and Registration Analyst. In this role, I’m responsible for various tasks, registering medical devices and IVDs, developing and validating regulations, guidelines, and SOPs for full assessment, abridged, reliance, and recognition pathways, including developing strategies to quickly register devices on market in Rwanda. Additionally, I actively participate in various technical committees, including the clinical trial safety committee, Peer review committee for cosmetics and household chemicals, and the committee for good manufacturing practice at Rwanda FDA.

Dr. Emil Ivan Mwikarago

Department of Human Medicine and Device assessment & Registration, Division of Human Medicine, Assessment and Registration - Rwanda FDA 

MS. SARAH COHEN

Position: Executive Officer at Southern African Laboratory Diagnostics Association (SALDA)
Categories: MedDev Speakers 2023
  • Cohen has over 25 years’ experience in laboratory testing and research, specializing in IVDs and clinical trials.

Executive Officer – SALDA – since August 2019

  • Liaising with members and other stakeholders as needed relating to the MedTech Industry with emphasis on IVDs

Offers support in laboratory management, accreditation and oversight of  clinical trial laboratories

Monitoring , assessing and auditing of clinical trial and laboratory  processes

Training, lecturing, coaching and mentoring of clinical trial staff / pharmaceutical sciences students

She has previously held senior positions in the fields of laboratory medicine and clinical trials

Education

She obtained her Bachelor degree in Laboratory Management (Pretoria), Masters in Operations

Management (Johannesburg) and MBA (Australia)

MS. SARAH COHEN

Executive Officer at Southern African Laboratory Diagnostics Association (SALDA)

Mr. Emmanuel Armon

Position: DEPUTY-DIRECTOR, HEAD OF BIOLOGICS, VACCINE AND MEDICAL DEVICES DIVISION - NAFDAC
Categories: MedDev Speakers 2023
  • Emmanuel Emori Armon is a pharmacist and a public health professional of twenty-three (23) years of experience in diverse areas of pharmaceutical regulatory affairs. The foremost thirteen (13) years of his career in NAFDAC was in the Investigation and Enforcement Directorate, where he headed the Cybercrime and Miscellaneous Offences (CMO) Unit charged with the responsibility of  strengthening and re-positioning the Directorate’s Activities against the forgery of NAFDAC documents and cyber-related activities on substandard and falsified medicines; coordinating the Directorate’s participation in Operation Opson V and investigating public complaints and post-surveillance activities to ensure that registered products meet prescribed registration standards post-registration.

    He has also been in the Drug Registration and Regulatory Affairs Directorate, where he has been involved in regulatory activities geared towards ensuring access to safe and quality medicines namely:

    • Development of the first controlled medicines regulation gazette. This document prescribed the mandatory context for importers, manufacturers, and regulators.
    • Member of the Technical Working Group (TWG) that worked with United States Agency for International Development (USAID) and United States Pharmacopeia (USP) to develop NAFDAC monitoring and evaluation plan for pharmaceuticals.
    • Member of NAFDAC Technical Working Group on AFCFTA. The TWG was mandated to work with the country’s NAC-AFCFTA on inputs on the implementation plan of the Trade agreement, decisions on the Rules of Origin and workstreams meetings
    • Participated in the review and update of the NAFDAC 5+5 validity policy list and Agency Ceiling List of imported pharmaceuticals. These are 2 critical policies implemented to enhance local manufacturing of Pharmaceuticals.
    • Represented the Agency at the 2022 UNITAID Industrial engagement “access to health innovation” forum in South Africa. UNITAID is a global health organization engaged in funding innovation solutions to prevent, diagnose, and treat diseases more quickly, affordable and effectively, in low- and middle-income countries.

    Presently, Emmanuel is a Deputy-Director and is in charge of the registration of Biologics, Vaccines and Medical Devices in NAFDAC, undertaking the following:

    • Reviewing submissions including dossiers to support registrations of vaccines, biologics and medical devices licencing.
    • Issuing permits for registration samples.
    • Licencing and issuing marketing authorizations
    • Reviewing submission for post-approval variation
    • Issuing approval for post approval variations.

    He is also a WHO-trained in-vitro diagnostic device dossier assessor and NAFDAC’s focal person for WHO Collaborative registration Procedure for medical devices

     

Mr. Emmanuel Armon

DEPUTY-DIRECTOR, HEAD OF BIOLOGICS, VACCINE AND MEDICAL DEVICES DIVISION - NAFDAC

Ms. Rana Chalhoub

Position: Regulatory Affairs Director - Mecomed
Categories: MedDev Speakers 2023

Rana Chalhoub is an experienced Regulatory Affairs Professional with a demonstrated history of working in leading multinational medical devices companies such as Medtronic, Johnson & Johnson and Hospira Pfizer. During her career, Rana has managed to take over regulatory roles of increased responsibilities with an extended area coverage where she has built extensive knowledge of the regulations across MEA region. Rana holds a Laboratory Sciences degree along with a Regulatory Affairs Certification (RAC) from RAPS, along with a certificate in “Regulation: Theory, Strategy & Practice” from London School of Economics & Political Sciences (LSE).

In her current role as Regulatory Affairs Director at Mecomed, Rana is responsible for managing Regulatory Affairs-related responsibilities in MECOMED, the Medical Technology Association in Middle East and Africa, and works closely with Mecomed RA and executive teams on advancing Medical Technology regulations in the region.

She acts as the link between MECOMED members and external stakeholders such as Ministry of Health officials and Regulatory agencies with special emphasis on the prioritization of the RA needs of the MedTech industry.

Ms. Rana Chalhoub

Regulatory Affairs Director - Mecomed

MR. MONIR EL AZZOUZI

Position: CEO & Founder - Easy Medical Device
Categories: MedDev Speakers 2023

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory affairs. He has worked for multiple Medical Device company where he acquired 15 years of experience. Within his experience he had to develop Quality and Regulatory affairs departments, obtain CE marking for Medical Devices, register products all over the world, deal with audits as Management Representative.

He has now created Easy Medical Device to support Medical Device companies that need help to place compliant products in the Market. He also educates the Medical Device community through his Blog, Podcast and Youtube channel. By educating everyone, we prevent issues to happen.

His motto “Would I give this product to a member of my family”. This helps him to take decisions.

MR. MONIR EL AZZOUZI

CEO & Founder - Easy Medical Device

Dr. Abdelrahman Abdellatif

Position: Regulatory Affairs Team Leader – MRG (Egypt)
Categories: MedDev Speakers 2023

Abdelrahman is a distinguished Regulatory Affairs Team Leader with a career spanning over 11 years, demonstrating excellence in diverse sectors such as medical devices, pharmaceuticals, nutraceuticals, and cosmetics. His exceptional track record extends beyond Egypt, encompassing a history of successful product registrations across global markets in Africa, GCC, and the LEVANT region.

His commitment to excellence is further underscored by his prestigious ISO 13485:2016 internal auditor certification and his leadership in spearheading intricate certification projects within the medical device sector.

He adeptly ensures organizational compliance while optimizing registration processes, consistently empowering 40+ manufacturers to expand their global presence and streamline their operations.

The attainment of an MBA degree has equipped Abdelrahman with a strategic mindset and a broader perspective, significantly enhancing his effectiveness as the Regulatory Affairs Team Leader.

Dr. Abdelrahman Abdellatif

Regulatory Affairs Team Leader – MRG (Egypt)

Dr. Hamoud AlSahli

Position: Regulatory Affairs Team Leader – MRG (KSA & UAE)
Categories: MedDev Speakers 2023

Hamoud holds a bachelor’s degree in Pharmaceutical Technology from Jiangnan University, supplemented by a Diploma in Chinese Language from the same esteemed institution. He is a highly proficient Regulatory Affairs leader with specialized expertise in Pharmaceutical and Medical Device product Registration within the Saudi Arabian market.

Hamoud’s exceptional leadership skills and effective time management abilities have enabled him to successfully navigate the complexities of regulatory affairs. He is not only skilled in managing regulatory processes but also adept at leading and mentoring cross-functional teams.

Managing relationships with 400+ manufacturers across both KSA and the UAE, Hamoud’s exceptional leadership and organizational skills have empowered him to seamlessly oversee diverse product categories, including Sterile, Non-Sterile IVD, Medium Risk, and High-Risk items. His profound understanding of the stringent regulations and standards set forth by SFDA is complemented by a demonstrated ability to navigate complex regulatory landscapes.

Dr. Hamoud AlSahli

Regulatory Affairs Team Leader – MRG (KSA & UAE)

Ms. Shaimaa Salah

Position: Regulatory Affairs Associate Director North Africa & Middle East Clusters - Alcon
Categories: MedDev Speakers 2023

Presently, Ms. Shaimaa Salah occupies the role of Associate Director for the Middle East & North Africa Clusters at Alcon. Armed with an extensive background exceeding 15 years in the field of regulatory affairs, Ms. Salah’s professional trajectory spans both the private and governmental sectors, with a focused dedication to generics and innovative products within local and regional contexts.

Her expertise extends across the pharmaceutical and medical device landscape, with specific proficiencies encompassing regulatory compliance, supply chain management, pricing strategies, and market access. Possessing remarkable interpersonal capabilities, including adeptness in presentation, communication, and analytical thinking, Ms. Salah showcases an innate creative flair and a steadfast commitment to continuous learning and innovative practices. Problem-solving is a hallmark skill, complemented by her adeptness in conducting skillful negotiations and cultivating positive relationships with Local Health Authorities. Her journey in the realm of regulatory affairs commenced with a role as a regulator in the Ministry of Health in Egypt, subsequently advancing to lead the planning and importation department within the Egyptian drug authority (EDA).

Having completed her education at the Faculty of Pharmacy at Cairo University, Ms. Salah pursued further academic achievements, obtaining an MBA with a specialization in supply chain management from AAST. Notably, she recently secured certification as a lean six sigma green belt. In her current capacity, Ms. Salah shoulders the responsibility of formulating meticulous regulatory strategies, pivotal in guiding the introduction of new products, facilitating geographical expansion, overseeing licensing procedures, and adeptly managing potential regulatory risks to ensure a steadfast commitment to compliance.

Ms. Shaimaa Salah

Regulatory Affairs Associate Director North Africa & Middle East Clusters - Alcon

DR. ASMA AWAD

Position: Global Regulatory Policy Lead E E M E A – Roche Diagnostics
Categories: MedDev Speakers 2023

She is deeply committed to utilizing her expertise and collaborating with various stakeholders to champion the field of regulatory science and to drive positive change in the healthcare ecosystem to ensure patients have access to safe and innovative products.

In her current position, she collaborates closely with various external stakeholders, including the World Health Organization (WHO), the Global Harmonization Working Party (GHWP), the Medical Device Regulatory Capacity Building (MDRC) project team, Mecomed, and national regulatory authorities.

Together, they drive the convergence, reliance, and adoption of international best practices, ultimately accelerating patient access to innovative healthcare products. Through these efforts, they aim to improve patient health outcomes and alleviate the burden on the healthcare ecosystem.

Her area of expertise is in medical devices and in vitro diagnostics (IVDs), with a specific focus on regulatory policy and capacity building for regulatory professionals.

Prior to her current role, she served as the Regional Regulatory Affairs Manager for the Middle East and Africa, leading significant projects such as MDR/IVDR and Brexit. In this position, she ensured compliance with regulatory requirements and provided strategic guidance to cross-functional teams to bring innovative products to market.

DR. ASMA AWAD

Global Regulatory Policy Lead E E M E A – Roche Diagnostics

Ms. Salma Salim

Position: Senior Regulatory Affairs Manager at GE HealthCare
Categories: MedDev Speakers 2023

Senior Regulatory Affairs Manager at GE HealthCare and based in Casablanca. Salma is responsible for the Regulatory Affairs activities and leading the relationship with Healthcare’s regulators in French speaking Africa and Northeast Africa.

Salma joined GE HealthCare in 2011 as RA leader in France. Since then, she has held a variety of roles with increasing responsibility in Regulatory Affairs for different GE HealthCare portfolio and regions.

Salma holds a master’s degree in quality and healthcare products from the Pharmaceutical University “Châtenay Malabry” in France.

Ms. Salma Salim

Senior Regulatory Affairs Manager at GE HealthCare

Ms. Loshnee Vandayar

Position: Senior Manager, International Regulatory Affairs (Middle East and Africa) - Cepheid
Categories: MedDev Speakers 2023

Loshnee has a BSc in Biochemistry and Microbiology from the University of KwaZulu Natal, a National Diploma in Biomedical Technology from the Cape Peninsula University of Technology as well as a Post Graduate degree in Business Management. She has extensive, hands on laboratory experience and has worked in the Medical Device and IVD industry for over 15 years with managerial positions in both Quality Assurance, Compliance and Regulatory Affairs. She has been with Cepheid since 2019 and currently holds the role of Senior Manager, International Regulatory Affairs for Middle East and Africa.

Ms. Loshnee Vandayar

Senior Manager, International Regulatory Affairs (Middle East and Africa) - Cepheid

Dr. Mary Kinyanjui

Position: Senior Regulatory Affairs Specialist - Cepheid
Categories: MedDev Speakers 2023

Mary has a Bsc in Pharmaceutical Sciences and Technology from Maseno University, and a post graduate Diploma in Public Health from Kenyatta University. She has extensive hands-on experience in the Pharma manufacturing industry and over 7 years of experience in regulatory affairs and Quality Assurance. She is the current Vice Chair for MEDAK(Medical Technology Industry Association of Kenya) and member of the regulatory and Trade committee. She has been with Cepheid since 2020 and currently holds the role of Senior Regulatory Affairs Specialist over East, West, and North Africa

Dr. Mary Kinyanjui

Senior Regulatory Affairs Specialist - Cepheid

MR. DARIO BELLUOMINI

Position: MANAGER INTERNATIONAL AFFAIRS – MEDTECH EUROPE
Categories: MedDev Speakers 2023

Dario Belluomini is Manager International Affairs at MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices, and digital health.

In this position, he manages and coordinates project and working groups addressing market access, trade policy initiatives and international regulatory matters in the medical technologies sector, with a primary focus on the countries outside of Europe.

He is experienced in representing the organization before multiple institutional stakeholders as well as engaging with third country authorities and international fora (e.g., IMDRF, GMTA). Earlier in his career, he coordinated market trackers and ad hoc market intelligence projects in the medical technologies sector. He holds a Master’s Degree in International Trade from the University of Antwerp (Belgium).

MR. DARIO BELLUOMINI

MANAGER INTERNATIONAL AFFAIRS – MEDTECH EUROPE

MR. MOHAMAD EL MOUALLEM

Position: REGULATORY AFFAIRS MANAGER, META – COOPERSURGICAL
Categories: MedDev Speakers 2023

Mohamad has been working in the field of medical devices and pharmaceuticals for more than 14 years. He has been on both sides of the supply chain, distributor and manufacturer, and has an experience in different fields such as orders management, business support & regulatory affairs.

Mohamad works with CooperSurgical, a leading manufacturer of IVF products, and since 2021 he is occupying the role of Regulatory Affairs Manager for Middle East, Turkey and Africa. He holds an MBA degree and a master’s degree in Law.

MR. MOHAMAD EL MOUALLEM

REGULATORY AFFAIRS MANAGER, META – COOPERSURGICAL

DR. HAYTHEM SABRY

Position: HEAD OF REGULATORY SOLUTIONS – GS1
Categories: MedDev Speakers 2023, RA Speakers 2023

He graduated from the Faculty of Pharmacy in 2008, then he joined the marketing, sales and Business administration diploma at the American University in Cairo and the Naval Academy as well.

He started his career in the Egyptian Drug Authority (formerly the Ministry of Health and Population) in 2013 and worked gradually until he reached the Head of Digital Transformation in EDA.

His big focus was managing the track and trace project in Egypt from 2018 until 2020 adding to that he managed to transform the registration to be automatically and having company profile for each entity registering in EDA then he decided to move to GS1 Egypt, where he is responsible for helping in implementing the GS1 standards in the healthcare sector and continuing to manage track and trace and other projects such as the UDI project for medical supplies, which was implemented in Egypt in 2021-2022 and other projects related to the health care sector in Egypt.

DR. HAYTHEM SABRY

HEAD OF REGULATORY SOLUTIONS – GS1

Ms. Avanthi Govender Bester

Position: Member of the Board, past Chair and Vice Chairperson - SAMED
Categories: MedDev Speakers 2023

Avanthi is the Associate Director-Regulatory and Quality at Alcon Laboratories South Africa across a portfolio of medical devices and pharmaceuticals. Prior roles involved various Regulatory and Quality responsibilities in Sub-Saharan Africa.

She is a member of the Board, past Chair and Vice Chairperson of SAMED, and an Associate Executive Member of the Industrial Pharmacy Section of FIP (since 2008).

Avanthi is a registered pharmacist, with a Master’s degree in Health Economics and Pharmacoeconomics.

She has worked in both the private and public sectors of South Africa covering the retail, hospital, academic and industry sectors, and in Singapore.

Avanthi has a particular interest in access to healthcare in Africa, specifically focusing on the regulatory mechanisms that enable these processes.

Ms. Avanthi Govender Bester

Member of the Board, past Chair and Vice Chairperson - SAMED

Dr. Lydia Mina

Position: Regulatory Affairs Regional Manager For The Region: METAP & UK (Middle East, Turkey , Africa & Pakistan & UK ) - ABBOTT
Categories: MedDev Speakers 2023

Dr. Lydia Mina’s impressive regulatory experience is complemented by her strong commercial background in the Middle East region. During her tenure at Merck Sharp & Dhome, she held the pivotal role of overseeing regulatory submissions for Specialty products, including Oncology, Antibiotics, and HIV products, specifically for the Gulf Region.

Transitioning to Reckitt Benckiser, Dr. Mina assumed the position of Regulatory Lead for Pharma & Health Care products throughout the Middle East Region, showcasing her expertise in navigating regulatory intricacies across various domains.

Her career continued to ascend as she joined Abbott as the Regulatory Affairs Regional Manager, where she played a crucial role in facilitating the transition to IVDR & MDR within the AMTI region (Africa Middle East Turkey & India), and eventually extended her influence to the UK & METAP regions.

Beyond her regulatory prowess, Dr. Mina also demonstrated her versatility by serving as the Sales Manager for the Psychiatry & Neurology unit at Janssen Cilag, Egypt, a subsidiary of Johnson & Johnson Pharma companies, and later expanding her responsibilities to include the gastro business unit.

She is an esteemed member of the Regulatory Affairs Professional Society (RAPS) in the USA and holds a Diploma in e-CTD Masterclass from eXtedo E-Regulatory Affairs. Dr. Lydia Mina’s dedication to professional development is evident through her certifications from the Saudi Council for Health Specialists and the European Pharma Consultant group, specifically in the field of Regulatory affairs for Saudi FDA.

In addition to her extensive professional achievements, Dr. Mina has pursued higher education, earning an MBA from Warnbough College in the UK. She also holds a Diploma in Marketing & Salesmanship from the American University in Cairo and graduated with a Bachelor of Pharmacy & Science from Alexandria University. Her diverse educational background further enhances her multifaceted expertise in the field.

Dr. Lydia Mina

Regulatory Affairs Regional Manager For The Region: METAP & UK (Middle East, Turkey , Africa & Pakistan & UK ) - ABBOTT

Dr. Rima Nsheiwat

Position: Regulatory Access and Market intelligence Strategist and Consultant - B.V. Amsterdam Medical & Scientific Alliance
Categories: MedDev Speakers 2023, RA Speakers 2023

With over 18 years of experience in regulatory access and market intelligence healthcare industry, I successfully assisted different MAHs, manufactures and companies in developing innovative strategies for entering new markets, focusing on all different market access perspective such as BD, regulatory, pricing and vigilance considerations.

Through my career in different healthcare stakeholders of which Shocair Group (Arab Drugstore, Arab Medical and scientific Alliance and Amsterdam Medical and scientific Alliance )which I served for more than 15 years which id Shocair group, I successfully established and managed different operational departments such as supply chain, quality compliance, in addition to regulatory and intelligence department, which gave me enrichment exposure to registration experience in different regions and from different perspectives. Moreover, I was part of the teams responsible for revision of different JFDA regulations, member in drug owner association, in addition to my active participation as a keynote speaker at numerous healthcare industry events, I regularly provide updates on the latest trends in regulatory affairs. Additionally, I serve as a business coach and trainer, helping companies unlock the potential of their employees through technical training and personalized coaching.

As for my qualification; by educations I`m a pharmacist with two master degrees; Public Health and MBA which both supported my remarkable achievements in different scopes. Moreover, through continuous education and commitment to unremitting learning I gained different professional certifications in different regulatory access and market intelligence fields such as quality pharmacovigilance auditing (International Colleague of London),  Professional GCC Regulatory Affairs Certificate (Dubai Pharmacy College), Certified Innovation Associate (GIMI), and Vocational Diploma in Regulatory Affairs of Pharmaceutical Products &Market Authorization (University of Jordan)

Recently, I`m working as a Regulatory Access and Market intelligence Strategist and Consultant through which I help companies to strategies their regulatory access in different countries with thorough market assessment. Support different MAHs in their regulatory projects within the region through creating innovative solution when coming to challenges faced with authority or other stakeholders. Furthermore, I create and implement effective business coaching plan for companies that positively reflected in their team achievements and increased quality of their work deliverables.

Dr. Rima Nsheiwat

Regulatory Access and Market intelligence Strategist and Consultant - B.V. Amsterdam Medical & Scientific Alliance

MS. SIMONE RUDOLPH-SHORTT

Position: Chairperson at MDMSA
Categories: MedDev Speakers 2023

An Industrial Pharmacist of 30 years. Started her career at Adcock Ingram (pre – Sterling Winthrop) in production of Panado tablets and Syrup before moving to Smith & Nephew in 1992, which became BSNmedical (2001), National Bio-products (20004) as Pharmacist Plant Manager (ampoules / Vials ) followed by own Consulting business 2005.

At Smith & Nephew, Introduced to medical devices such as burns creams, wound dressings, bandages and plasters and the new quality management system, at the time, ISO9001 and moving to ISO 13485 in 2000.

Worked in Production, Quality Assurance, Regulatory affairs, Validation and Laboratory Management of a chemistry, microbiology and textile laboratory.

In 2005, the consultancy business started providing;

  • Consultation on quality management systems (ISO9001/22001/13495) regulatory requirements, product licensing, company registration for medicines and medical devices
  • Training in-house or public venue on the development, implementation and maintenance of a quality managements system (ISO13485), good manufacturing practices and internal auditing for conformity assessment certification and
  • Documentation requirements for risk assessment (ISO 14971), procedures, clinical evaluation, technical file and declaration of conformity

A member of PSSA, SAAPHI, SAHFE, SAMED , MDPG (Chairperson 2019) MDMSA (chairperson 2021),  and is a committee member of the SAMED Regulatory and Procurement committees and the SABS Technical committees for textiles and medical devices

MS. SIMONE RUDOLPH-SHORTT

Chairperson at MDMSA

DR. RAMI MANSOUR

Position: Regulatory Affairs Manager, Egypt – Becton Dickinson
Categories: MedDev Speakers 2023

Rami is currently the Regulatory Affairs Manager at Becton Dickinson supporting Egypt. He has over 11 years of experience in regulatory affairs of medical devices and has worked in different markets in the Middle East to include but not limited to KSA, Jordan, Syria, Libya, and Yemen. He is originally a pharmacist, holding a master’s degree in pharmacology from Azhar University and a hospital management diploma from the American University in Cairo.

DR. RAMI MANSOUR

Regulatory Affairs Manager, Egypt – Becton Dickinson

Dr. Marwa Said

Position: Regulatory Affairs Manager - Boston Scientific
Categories: MedDev Speakers 2023

Marwa Said is a Regulatory Affairs Manager at Boston Scientific with 14 years of experience in the Medical Devices Regulatory Affairs field.

Preceded by 12 years of experience as a pharmacist in different Health Care foundations.

I am passionate about Regulations in the MEA region and am always looking for new ways to use technology to make a difference.

I am honored to be a member of the Mecomed Trade association team because it gives me the chance to contact the regulators all over the region and contribute in shaping the regulations.

Dr. Marwa Said

Regulatory Affairs Manager - Boston Scientific

Dr. Nariman Hussein Fahmy

Position: Senior RA Specialist Gulf & Levant - Johnson & Johnson
Categories: MedDev Speakers 2023

She is a Pharmacist & RAC certified.

She has over 17 years of Experience in Medical devices & pharmaceutical registration in a Regulatory Affairs Career.

Her Current role at Johnson & Johnson MEDTECH is as Senior Regulatory Affairs Specialist Gulf, Levant & Iraq.

She has more than 9 years of general regional diversified experience between Saudi Arabia, Pakistan & the Middle East.

She has management experience of 4 years in Egypt at DKT International as Regulatory Affairs Manager Egypt. Dr.Nariman is Based in Cairo, Egypt.

Dr. Nariman Hussein Fahmy

Senior RA Specialist Gulf & Levant - Johnson & Johnson

Dr. Hassiba Chemli

Position: Regulatory Affairs Manager, Regional Vigilance officer, MENA – Lohmann & Rauscher
Categories: MedDev Speakers 2023

Dr. Hassiba Chemli

Regulatory Affairs Manager, Regional Vigilance officer, MENA – Lohmann & Rauscher

Dr. Carol Attieh

Position: Growth Emerging Markets (GEM) Regulatory Lead - Boston Scientific Middle East FZ LLC
Categories: MedDev Speakers 2023

Senior Regulatory & Quality professional with more than 20 years’ experience in multinational environment and emerging regulations including leading, planning and implementing strategies, policies & procedures for the Regulatory Affairs & Quality Assurance department for  Boston Scientific. Solid experience in working with Health Authorities throughout the Middle East, Africa and rest of emerging markets. One of founding and active member of Mecomed since 2007 currently acting as Chair of the regulatory committee.

Dr. Carol Attieh

Growth Emerging Markets (GEM) Regulatory Lead - Boston Scientific Middle East FZ LLC

AHMED HACHAMI

Position: Regulatory Affairs Specialist - Johnson & Johnson MedTech
Categories: MedDev Speakers 2023

In his current job role, he is responsible for all aspects of regulatory activities for Maghreb, Ghana, Mozambique, and French West Africa.

Prior to his current job role, Mr. Ahmad has worked at BBraun Medical, Siemens Healthiness, Thales AVS France till 2018, and from 2011 he began at ANSM (French Health Authority), as a vigilance evaluator.

He is an active member in local and regional Trade Associations (SNITEM, MECOMED, AMPDM).

In addition, he is a speaker at Dubai Pharmacy College & PRA Consultancy’s Medical Device Regulation Masterclass MENA in the year of 2021 and 2022.

AHMED HACHAMI

Regulatory Affairs Specialist - Johnson & Johnson MedTech

Mr. Charle Leibbrandt

Position: Partner - VECTOR Life Sciences (Pty) Ltd
Categories: MedDev Speakers 2023

Charle Leibbrandt is a partner of VECTOR Life Science. He is responsible for overall business development and the strategic growth of products and markets. He gained his experience in the electrical and Automotive arena where he fulfilled the role of managing director in South Africa and Zambia.

Mr. Charle Leibbrandt

Partner - VECTOR Life Sciences (Pty) Ltd

Dr. Alaa Okasha

Position: Regional Senior Regulatory Affairs Associate for GCC and GETM - STADA MENA
Categories: MedDev Speakers 2023

A pharmacist with 14+ years of regulatory experience on both Local and Regional levels. Combining both Governmental and Pharmaceuticals companies experience.

Dr. Alaa Okasha

Regional Senior Regulatory Affairs Associate for GCC and GETM - STADA MENA

Ms. Majda Mghimimi

Position: Senior Regulatory Affairs Specialist French Speaking Africa – Medtronic
Categories: MedDev Speakers 2023

Majda Mghimimi is Moroccan based in Casablanca. She is a Senior Regulatory Affairs Specialist for North Africa and French-speaking Africa at Medtronic.

She holds a master’s degree in Marketing and Immunology. She has prior experiences in diverse departments: Regulatory Affairs, Quality Control, Compliance and Customer Relationship Management, with other renowned multinational l compagnies operating in the Pharmaceutical and Medical Devices field (Roche – Fresenius – 3M).

As a scientist, leading relationships with healthcare regulators and various internal and external stakeholders, our mission is to facilitate patient access to appropriate and better Health products and Medical Devices, making regulation our ally in overcoming environmental challenges.

Ms. Majda Mghimimi

Senior Regulatory Affairs Specialist French Speaking Africa – Medtronic

Dr. Fatma Wahdan

Position: Regulatory Affairs and Quality Assurance Manager - Medtronic Egypt & Libya Cluster
Categories: MedDev Speakers 2023

A pharmacist by graduation, with 17+ years of Regulatory experience on Local, Regional and Global levels.

Fatma has a proven track of record in regulatory strategy setting and advocacy activities combining the Governmental, Pharmaceutical, and Medical device companies experience.

Dr. Fatma Wahdan

Regulatory Affairs and Quality Assurance Manager - Medtronic Egypt & Libya Cluster

Mr. Kent Briggs

Position: Director - VECTOR Life Sciences (Pty) Ltd
Categories: MedDev Speakers 2023, RA Speakers 2023

Kent Briggs is the Managing Director at VECTOR Life Sciences. He began working with eSubmissions in 2002 and eCTDs when they were first implemented in 2003. He has provided industry workshops in the US, Canada, Europe, South Africa, India and Australia and has performed application compilation training with both big and small pharmaceutical companies around the world. In addition to performing evaluator training at over 20 health authorities, Kent has authored the eCTD specifications for 4 regions including the soon to be released specifications for ECOWAS. Since 2014, Kent has focused on the CTD in Africa and supporting the harmonization efforts through regional and continental activities.

VECTOR Life Sciences is a service provider for the African regulatory market with a key focus on the implementation and usage of electronic systems to improve regulatory efficiency. VECTOR supports customers in their transition from paper based methods to electronic processes by streamlining their regulatory operations and making their use of data more effective

Mr. Kent Briggs

Director - VECTOR Life Sciences (Pty) Ltd

Featured Testimonials

2022 SPEAKERS

MS. NADIA BEL HADJ AMMAR

Position: Pharmacist R. technical import control - Biology Laboratories Unit at Ministry of Health, Tunisia
Categories: meddevreg 2022

Unité des laboratoires de biologie médicale – Ministère de la santé de Tunisie

Pharmacien de la santé – depuis avril 2019

  • Contrôle technique à l’importation des DMDIV
  • Réactovigilance et surveillance du marché
  • Gestion des dossiers de création, de transfert et de fermeture des laboratoires privés de biologie médicale

MedicaSud

Directeur médical – janvier à avril 2019

OPALIA RECORDATI industries

Délégué médical – juin 2017 à octobre 2018

Novopharm SARL

MS. NADIA BEL HADJ AMMAR

Pharmacist R. technical import control - Biology Laboratories Unit at Ministry of Health, Tunisia

MR. EMMANUEL NKRUMAH

Position: DIRECTOR FOR THE MEDICAL DEVICE, COSMETICS AND HOUSEHOLD CHEMICALS DIRECTORATE AT THE FOOD AND DRUGS AUTHORITY (FDA) - GHANA
Categories: meddevreg 2022

Emmanuel Nkrumah is the Director for the Medical Device, Cosmetics and Household Chemicals Directorate at the Food and Drugs Authority (FDA), Ghana. He has been a regulatory officer for eighteen years with immense experience in Food, Drugs, Medical devices, Cosmetics and Household chemicals regulation.

 

Emmanuel holds a Bachelor’s degree in Biological Sciences from the Kwame Nkrumah University of Science and Technology, Kumasi and a Master’s degree in Pharmaceutical Sciences from the University of Greenwich, United Kingdom.

Emmanuel is a member of the Food and Drugs Authority’s GMP inspection team (as a GMP Lead inspector) and a member of the Drugs Product Registration Committee of the Food and Drugs Authority.

He is also a member of the Technical Committee (National committee) responsible for drafting standards for the Cosmetics and Household chemicals industry at the Ghana Standards Authority, and also the Ghana Society of Dermatology.

 

Emmanuel has a strong background in the regulation of medical devices, cosmetics and household chemicals in Ghana, and has been involved in the drafting of a number of policies for the regulation of the medical devices, cosmetics and household chemical industry in Ghana; and has represented Ghana on the international stage having delivered a presentation including Cosmetic Regulation in West Africa.

MR. EMMANUEL NKRUMAH

DIRECTOR FOR THE MEDICAL DEVICE, COSMETICS AND HOUSEHOLD CHEMICALS DIRECTORATE AT THE FOOD AND DRUGS AUTHORITY (FDA) - GHANA

MS. ASMA ELFASSI

Position: Auditor ISO13485 at DQS Inc.
Categories: meddevreg 2022
  • ISO13485 Auditor/ Lead auditor-Freelancer

Medpoint LLC-USA

  • ISO13485 Auditor/ Lead auditor-Freelancer TD File reviewer –MDD93/42/EEC

Under Qualification MDR2017/745 and MDSAP

DQS MED-Notified Body N°0297

  • ISO 13485 Auditor-Freelancer

Rina certification – Italian Notified body

  • Project manager

Sartorius Stedim Bioprocess -Tunisia

Medical device manufacturer: bags for parenteral nutrition injection and transfer lines

Company under ISO13485-Products under CE mark MDD 93/42/EEC

  • Quality Director and regulatory affairs- medical device industry

Epsilon Orthopedics (Tunisia)/ Smart Spine (France)

Medical device manufacturer: implantable intersomatic cages; metallic osteosynthesis

screws and plates

Company under ISO13485-Products under CE mark MDD 93/42/EEC

MS. ASMA ELFASSI

Auditor ISO13485 at DQS Inc.

MS. MICHELLE BRONZE

Position: Technical Director at Diagnostech
Categories: meddevreg 2022

Michelle completed her PhD (Molecular Medicine) through the University of the Witwatersrand in 2013, exploring in vitro HIV-1 drug resistance phenotyping, genotyping and novel virological failure detection tools for clinical patient management. Her research was performed at Virco Lab, Inc (now Janssen Diagnostics) in Belgium and at the NHLS in Johannesburg. Michelle put into practice her PhD acquired skills at partner laboratories in Zimbabwe (Newlands Clinic; Harare) and Uganda (JCRC; Kampala, Fort Portal, Mbale). Post-PhD, she spent much of her career in the molecular research and diagnostics environment and related quality systems at the NHLS, focusing on HIV drug resistance and haematological malignancies. She was actively involved with the development of education programmes and training of haematopathology registrars, intern medical scientists, and medical technologists. As a project manager, Michelle carried out the design and implementation of an NHLS dashboard to enable the monitoring of performance indices of the Department of Health’s HIV programme. She is a registered medical scientist with the Health Professions Council of South Africa and currently serves as an examiner for intern medical scientist portfolios.

Having joined Diagnostech (research and IVD distributor company) in 2015, Michelle strives to enhance the use of state-of-the-art technologies to drive the highest level of quality research and diagnostics in Africa. She has a personal interest in translational research focusing on the medical diagnostics environment. Within the IVD regulatory context, she’s currently an executive member of the Southern Africa Laboratory Diagnostics Association (SALDA), a member of the SAMED regulatory committee, and the Management Representative for Quality and Technical Director at Diagnostech.

MS. MICHELLE BRONZE

Technical Director at Diagnostech

DR. OLFA BEN SMIDA

Position: Public Health Pharmacist/ Pharmacy and Medicines Unit
Categories: meddevreg 2022

Depuis Septembre               Pharmacien de la santé publique/ Unité                 

2015                  de la Pharmacie et du Médicament

(Décembre 2019)                   Chef de service de la commercialisation des produits pharmaceutiques et para pharmaceutiques à la sous-direction de l’industrie des produits pharmaceutiques et para pharmaceutiques et du contrôle de leur commercialisation

(Depuis Février 2017)            En charge du Contrôle Technique à l’Importation (CTI)

  • Gestion et réponse aux courriers (émanant du BO du Ministère/ électroniques) relatifs aux dispositifs médicaux et aux produits parapharmaceutiques
  • Evaluation administrative des dossiers d’enregistrement de dispositifs médicaux soumis au Contrôle Technique à l’Importation
  • Evaluation de la recevabilité et gestion des dossiers de demande de commercialisation de produits frontières, de laits infantiles et des produits apparentés et de filtres d’hémodialyse
  • Etude et validation des demandes déposées à la DPM concernant le dédouanement de matières premières, de dons et d’échantillons de dispositifs médicaux et de produits para pharmaceutiques, concernant les Privilèges fiscaux et concernant l’export des produits mentionnés ci dessus
  • Réception des usagers pour répondre à leurs questions, suivre et résoudre les problèmes qu’ils rencontrent
  • Préparation et suivi des travaux du Comité Technique de classification des produits frontières, de la Commission Nationale Pour la Promotion de l’Alimentation du Nourrisson et de l’Enfant et du Comité Technique d’Agrément des Filtres d’hémodialyse
  • Préparation et suivi des travaux des réunions de la DPM concernant tout sujet relatif au CTI, aux Dispositifs médicaux et aux produits para pharmaceutiques
  • Gestion des réclamations liées aux dispositifs médicaux et aux produits parapharmaceutiques
  • Rédaction des notes destinées au Ministre et des avis destinés aux usagers
  • Contribution à l’élaboration et à la révision des textes juridiques liés au CTI, aux Dispositifs médicaux et aux produits para pharmaceutiques
  • Représentation de la DPM dans les réunions interministérielles et au sein du Ministère concernant tout sujet relatif au CTI, aux Dispositifs médicaux et aux produits para pharmaceutiques
  • Contribution à la rédaction et à l’amélioration des procédures de travail
  • Organisation et gestion de l’équipe du service du CTI

(Sep 2015- Jan 2017)  Pharmacien Evaluateur Médicament/CTI

  • Evaluation de la partie administrative des dossiers de demande d’AMM
  • Traitement et suivi des réclamations relatives à la qualité, l’efficacité et la pharmacovigilance des médicaments
  • Traitement des commandes fermes
  • Gestion des dossiers de produits frontières (entre médicaments et autres statuts)
  • Contribution à l’élaboration et à l’amélioration des procédures
  • Représentation de la DPM dans les réunions

   Novembre 2011-                Pharmacien Responsable Affaires

      Août 2015           Réglementaires/ Société Tradisco – 

(Laboratoires pharmaceutiques Reckitt   Benckiser)

  • Préparation, suivi et dépôt des dossiers de nouveaux médicaments (importés) en vu d’obtention d’AMM
  • Préparation, dépôt et suivi des dossiers de demande du CTI auprès de la Direction de la Qualité et de la Protection du Consommateur (Ministère du Commerce), de la DPM et de Direction de l’Hygiène du Milieu et de la Protection de l’Environnement (Ministère de la Santé) en vu d’obtention de l’Autorisation de Mise à la Consommation
  • Contribution à la mise en œuvre de la stratégie technico-réglementaire de l’entreprise
  • Contribution à la gestion des Ressources Humaines

Avr 2011- Sep 2011        Pharmacien Assistant/ Pharmacie

Déc 2009 – Juin 2010     Catégorie A   

  • Dispensation des médicaments
  • Traitement des bulletins de soins
  • Réalisation des préparations magistrales et officinales
  • Conseil officinal
  • Gestion du stock

        Responsabilités assurées

Emploi fonctionnel

Chef de service de la commercialisation des produits pharmaceutiques et para pharmaceutiques à la sous-direction de l’industrie des produits pharmaceutiques et para pharmaceutiques et du contrôle de leur commercialisation depuis Décembre 2019.

Membre d’une commission

  1. Membre du Comité technique multisectoriel pour l’étude des dossiers d’importation de masques à usage unique suite à l’alerte Interpole depuis Janvier 2021.
  2. Membre du Groupe de travail chargé de la création d’une centrale d’achat de dispositifs médicaux stériles à usage unique en 2020.
  3. Membre de la Commission d’élaboration du projet de décret relatif aux dispositifs médicaux (depuis 2017) au sein de l’ANCSEP.
  4. Membre de la Commission d’élaboration du projet de décret relatif aux compléments alimentaires (2015/ 2016/ 2019) au sein de l’ANCSEP.
  5. Membre de la Commission d’élaboration du projet de décret relatif aux produits cosmétiques (en 2016) au sein de l’ANCSEP.
  6. Membre du Comité Technique de Classification des Produits Frontières en tant que Coordinatrice (depuis 2017).
  7. Membre de la Commission Nationale pour la Promotion de l’Alimentation du Nourrisson et de l’Enfant en tant que Coordinatrice (depuis 2016).
  8. Membre du Comité Technique d’Agrément des filtres d’hémodialyse en tant que Coordinatrice (depuis 2016).

Divers

Qualités:

Sociable, organisée, rigoureuse, patiente, esprit d’équipe.

Langues : Arabe (Maternelle)/ Français (Principale)/ Anglais (Excellent)/ Allemand (Scolaire).

Hobbies:   Lecture/ Cinéma

 

DR. OLFA BEN SMIDA

Public Health Pharmacist/ Pharmacy and Medicines Unit

MR. NEVILLE MAYHEW

Position: Global Project Manager, South Africa, Import – Export Specialist, Africa Region at Oximio
Categories: meddevreg 2022

Neville is a Global Project Manager, Import Export Specialist, Africa Region at Oximio, responsibilities include the coordination and completion of all projects on time, within budget and to the client requirements. This involves overseeing all aspects of projects, monitoring and summarising progress of project and ensuring the reports are prepared key stakeholders of the business regarding status of project.

Oximio, previously known as the SMO Group, has a rapidly expanding GxP storage and services network focused on Eastern Europe, the Middle East and Africa. Along with the two facilities in serving the sub-Saharan region, Oximio also operates through a partner depot in Egypt in Africa.

Oximio in Kenya runs a Customs Bonded depot, and serves as a gateway to East, Central and West Africa. This enables cost-effective solutions and quick turnaround times in the region and substantially improves patient access to medicine, particularly in difficult to reach areas and marginalised populations.

Neville’s background

Neville entered the Clinical Supply Chain market in 2014 working for various carrier in the clinical trial sector and continues to build and maintain mutually beneficial relationships with local and international sponsors, manufacturers, and other key stakeholders including regulators and Research Organisations.

MR. NEVILLE MAYHEW

Global Project Manager, South Africa, Import – Export Specialist, Africa Region at Oximio

MRS. ROBYN HOWES

Position: Regulatory Manager, Core Diagnostics - South Africa at Abbott
Categories: meddevreg 2022

Robyn is a qualified Medical Technologist specialising in infectious diseases. She has worked in microbiology clinical laboratories for 8 years before entering the commercial environment. Robyn was a director of Bioweb Pty Ltd diagnostics company importing and exporting diagnostics reagents to laboratories and blood banks into Africa for 17 years.

She is a member of the Southern African Diagnostics Trade Association and held the post of Executive Officer between 2015 until 2018. During this time, she participated in the following SALDA and SAMED committees and activities:

Portfolio of activity:

-SAHPRA Legislation and Regulations

-MD and IVD Licence Applications

-Regulatory Educational Forums for Member Companies

-Laboratory Medicines Group

-NHLS HTA

-Point of Care

-SAMED Board (2015 – 2017)

-Medical Device Code of Ethical Marketing and Business Practice

-Health Economics and Reimbursement

-SALDA/SAMED Regulatory Committee

-Association governance and company membership management

It is in this role as Executive Officer of SALDA Robyn has been able to interact with several industry stakeholders which has given her valuable insight into the future path of the In Vitro diagnostic industry and the many challenges ahead.

Robyn was appointed as Regulatory Manager for Abbott Diagnostics Division in Oct 2018 which will allows her insight into the regulatory environment across the African Continent.

MRS. ROBYN HOWES

Regulatory Manager, Core Diagnostics - South Africa at Abbott

MR. ALBERT MAQOLO

Position: Senior Analyst of Microbiology and Medical Devices Unit at Medicines Control Authority of Zimbabwe
Categories: meddevreg 2022

Albert Maqolo is a Senior Analyst at the Medicines Control Authority of Zimbabwe in the Microbiology and Medical Devices Unit. He has more than 10 years of experience in the regulation of medical devices.  He specialises in regulation and quality conformity assessments of medical devices and in-vitro diagnostics.

He is an experienced ISO 13485 factory auditor and ISO 17025 Quality Management System (QMS) auditor. He is also a member of the ISO/TC 157 technical committee (Non-systemic contraceptives and STI barrier prophylactics).

Albert has played a key role in ensuring that the public has access to quality, safe and effective medical devices through development and continuous improvement of regulatory processes.

He has worked with international and regional organisations such as the United Nations Population Fund (UNFPA), World Health Organisation (WHO) and African Medical Devices Regulatory Forum (AMDF) to further improve the quality of health commodities through development of international guidelines and processes for regulating medical devices. He holds a BSc Honours Degree in Biological Sciences and a Master of Business Administration degree.

MR. ALBERT MAQOLO

Senior Analyst of Microbiology and Medical Devices Unit at Medicines Control Authority of Zimbabwe

MR. MARK BANFIELD

Position: Director of Mark Banfield & Associates Consulting & Member at Medical Device Professional Group
Categories: meddevreg 2022

MR. MARK BANFIELD

Director of Mark Banfield & Associates Consulting & Member at Medical Device Professional Group

MS. CHRISTINE WAHBA

Position: Senior Regulatory Affairs Specialist MEA at Align Technology
Categories: meddevreg 2022

Personal Interests and Fun Facts

Originally born and raised in Egypt, currently live in Dubai

Outside of work spend most hours in:  time with family & friends, practicing sports (Swimming, Basketball), have a walk, jogging, eat good food, love to travel!

Professional Background (13 yrs RA/QA Pharmaceutical& Medical Devices)

  • GSK (~8 yrs)
    Held multiple roles as microbiologist, raw material analyst (Quality Control), Quality Assurance, Change Control management, Risk management, Auditing, QMS, CAPA management, Complaints, Root cause Analysis.
  • Astellas Pharma, Pfizer Consumer Healthcare (~3 yrs)
    – Regulatory Affairs associate MENA
  • Hillrom (2 yrs)

-RAQA Specialist MEATI

Education

  • German University in Cairo
    S. Pharmacy and Biotechnology double major
  • RAPS Online University

-Regulatory Affairs Certificate: Medical Devices and

Pharmaceuticals (dual)

MS. CHRISTINE WAHBA

Senior Regulatory Affairs Specialist MEA at Align Technology

DR. NOHA EL-HARIRI

Position: General Director of Administration of Medical Device Registration, Egyptian Drug Authority
Categories: meddevreg 2022

Dr. Noha El Hariri is the general manager of the general medical device registration administration-Egyptian drug authority (EDA).

She had Bachelor of Clinical Pharmacy year 2003 with excellent grade with honor.
She had MBA (Master of Business Administration in health economics) with grade excellent with honor.

She worked in the central administration for pharmaceutical affairs since 2004 as inspector
In 2011 she left the inspection department and joined the medical device department since 2011.

In 2013 she became head of variation department in medical devices unit.
In 2020 she became general manager of registration department.

DR. NOHA EL-HARIRI

General Director of Administration of Medical Device Registration, Egyptian Drug Authority

MS. SARAH COHEN

Position: Executive Officer at Southern African Laboratory Diagnostics Association (SALDA)
Categories: meddevreg 2022
  • Cohen has over 25 years’ experience in laboratory testing and research, specializing in IVDs and clinical trials.

Executive Officer – SALDA – since August 2019

  • Liaising with members and other stakeholders as needed relating to the MedTech Industry with emphasis on IVDs

Offers support in laboratory management, accreditation and oversight of  clinical trial laboratories

Monitoring , assessing and auditing of clinical trial and laboratory  processes

Training, lecturing, coaching and mentoring of clinical trial staff / pharmaceutical sciences students

She has previously held senior positions in the fields of laboratory medicine and clinical trials

Education

She obtained her Bachelor degree in Laboratory Management (Pretoria), Masters in Operations

Management (Johannesburg) and MBA (Australia)

MS. SARAH COHEN

Executive Officer at Southern African Laboratory Diagnostics Association (SALDA)

MS. LOSHNEE VANDAYAR

Position: Manager, International Regulatory Affairs - Middle East and Africa at Cepheid
Categories: meddevreg 2022

MS. LOSHNEE VANDAYAR

Manager, International Regulatory Affairs - Middle East and Africa at Cepheid

MS. NADIA ISSAD

Position: Director Regulatory Affairs & Commercial Quality MEA -Turkey at Smith+Nephew
Categories: meddevreg 2022

MS. NADIA ISSAD

Director Regulatory Affairs & Commercial Quality MEA -Turkey at Smith+Nephew

MR. ROB VAN DEN BERGH

Position: Regional Director, sub-Saharan Africa at Oximio
Categories: meddevreg 2022

Rob is Regional Director, sub-Saharan Africa at Oximio, which includes operations in South Africa and the newly opened facility in Kenya. Both are licensed pharmaceutical distribution warehouses, specialising in global clinical trial supply procurement, comparator sourcing, repackaging, storage and distribution.

Oximio, previously known as the SMO Group, has a rapidly expanding GxP storage and services network focused on Eastern Europe, the Middle East and Africa. Along with the two facilities in serving the sub-Saharan region, Oximio also operates through a partner depot in Egypt in Africa.

Oximio in Kenya runs a Customs Bonded depot, and serves as a gateway to East, Central and West Africa. This enables cost-effective solutions and quick turnaround times in the region and substantially improves patient access to medicine, particularly in difficult to reach areas and marginalised populations.

Rob’s background

Rob entered the Clinical Supply Chain market in 2002 and continues to build and maintain mutually beneficial relationships with local and international sponsors, manufacturers, and other key stakeholders including regulators and Research Organisations.

As a leader, team player and brand ambassador, and through Oximio clients, Rob is focussed on attracting a wider range of research into sub-Saharan Africa.

MR. ROB VAN DEN BERGH

Regional Director, sub-Saharan Africa at Oximio

DR. FADOUA KHADIRI

Position: Docteur en pharmacie, lauréate de la Faculté de Médecine et de Pharmacie de Rabat, Maroc
Categories: meddevreg 2022

Fadoua Khadiri, Docteur en pharmacie, lauréate de la Faculté de Médecine et de Pharmacie de Rabat, Maroc en 2008.

Elle travaille actuellement et depuis Janvier 2019, au Centre Marocain de Pharmacovigilance. En plus des activités de la Pharmacovigilance et de la Vaccinovigilance et depuis 2020, elle s’occupe des activités relatives à la Matériovigilance, à savoir le traitement des notifications et la gestion de la base de données Marocaine des incidents liés au dispositifs médicaux.

Elle a participé dans des programmes de formation des professionnels de santé en matière de Pharmacovigilance.

Elle a commencé son exercice dans la fonction publique comme pharmacien hospitalier, elle a exercé en tant que pharmacienne responsable de la gestion de la pharmacie hospitalière. Elle a une expérience de 9 ans dans la gestion des médicaments et des dispositifs médicaux au niveaux des hôpitaux. Elle a travaillé également dans la gestion et la préparation des médicaments cytotoxiques utilisés en Oncologie en milieu hospitalier.

DR. FADOUA KHADIRI

Docteur en pharmacie, lauréate de la Faculté de Médecine et de Pharmacie de Rabat, Maroc

MS. MICHELLE BULLIARD

Position: Vice President, Global Head Real World Evidence, IQVIA MedTech
Categories: meddevreg 2022

Ms. Bulliard has over 25 years’ experience in real-world evidence studies, patient registries, safety surveillance programs, and other specialized real-world programs. She has an extensive global portfolio, specializing in medical device & diagnostics studies.

Ms. Bulliard works with medtech companies around the world to design & deliver solutions that translate evolving methodological real-world research standards and real-world data generation methods into feasible operational delivery strategies to meet the needs of regulators, payers, providers & patients.

A subject matter expert in RWE medical device, diagnostic and digital health studies with a robust knowledge of the current and evolving clinical, regulatory, scientific and commercial medtech landscape, she seeks to generate product value by leveraging the most effective, innovative and compelling strategies within the marketplace.

Ms. Bulliard is a member of IQVIA’s MedTech Center of Excellence representing the domain of real-world evidence.

She has previously held senior positions in the field of post market safety and real-world research in medical device and biotech companies.

Education

She has obtained her Bachelor of Science in Nursing, BScN, RN, from Dr Steevens Hospital  / Trinity College Dublin Ireland, with a P. Grad. Dip in Critical Care ICU Dublin, Ireland and Lausanne, Switzerland.

MS. MICHELLE BULLIARD

Vice President, Global Head Real World Evidence, IQVIA MedTech

DR. DIMAKATSO T. MATHIBE

Position: SENIOR MANAGER MEDICAL DEVICE UNIT AT SAHPRA & CO-CHAIR OF AMDF
Categories: meddevreg 2022

Has a PhD – Pharmacology from the University of Pretoria, MBL from SBL and project Management. Dr Mathibe has worked in both the pharmaceutical and medical device (IVD & Non|VD industry) for over the past 10 years with managerial positions in QA & RA. Her current role since April of this 2021 is with SAMPRA as the Senior Manager for Medical Device and Radiation control.

DR. DIMAKATSO T. MATHIBE

SENIOR MANAGER MEDICAL DEVICE UNIT AT SAHPRA & CO-CHAIR OF AMDF

SIMONE RUDOLPH-SHORTT

Position: Chairperson at MDMSA
Categories: meddevreg 2022

An Industrial Pharmacist of 30 years. Started her career at Adcock Ingram (pre – Sterling Winthrop) in production of Panado tablets and Syrup before moving to Smith & Nephew in 1992, which became BSNmedical (2001), National Bio-products (20004) as Pharmacist Plant Manager (ampoules / Vials ) followed by own Consulting business 2005.

At Smith & Nephew, Introduced to medical devices such as burns creams, wound dressings, bandages and plasters and the new quality management system, at the time, ISO9001 and moving to ISO 13485 in 2000.

Worked in Production, Quality Assurance, Regulatory affairs, Validation and Laboratory Management of a chemistry, microbiology and textile laboratory.

In 2005, the consultancy business started providing;

  • Consultation on quality management systems (ISO9001/22001/13495) regulatory requirements, product licensing, company registration for medicines and medical devices
  • Training in-house or public venue on the development, implementation and maintenance of a quality managements system (ISO13485), good manufacturing practices and internal auditing for conformity assessment certification and
  • Documentation requirements for risk assessment (ISO 14971), procedures, clinical evaluation, technical file and declaration of conformity

A member of PSSA, SAAPHI, SAHFE, SAMED , MDPG (Chairperson 2019) MDMSA (chairperson 2021),  and is a committee member of the SAMED Regulatory and Procurement committees and the SABS Technical committees for textiles and medical devices

SIMONE RUDOLPH-SHORTT

Chairperson at MDMSA

DR. MARIAM GEORGE LABIB

Position: Unit manger IVDs inspection department at Egyptian Drug Authority
Categories: meddevreg 2022

DR. MARIAM GEORGE LABIB

Unit manger IVDs inspection department at Egyptian Drug Authority

MS. SUSAN LIN

Position: SENIOR MANAGER: HEALTH POLICY DEVELOPMENT FOR MEDSCHEME HOLDING (PTY) LTD.
Categories: meddevreg 2022

She is a qualified pharmacist with a Bachelor of Pharmacy from Rhodes University and has worked extensively in the healthcare industry.  She has spent the majority of her career in health risk management / managed care.

Susan began her career serving as a dispensing pharmacist in public as well as private sector but later progressed to the Managed Care industry where she managed several portfolios. Her positions included the Executive Manager: Medicines Risk & Electronic Benefit Management and Specialist: Business Modelling & Coordination.

Her notable achievements was on the public and private partnership initiatives in enabling access to care. She consulted for a number of segments within the healthcare industry whereby she facilitated the streamlining of access to primary healthcare and development of technologies to support maternal and child care.

Currently, Susan is heading up the Health Policy Unit where she is responsible for the development of strategies for enabling access to pharmaceutical, technological and medical procedures. One of her ambitions is finding sustainable solutions in building reimbursement models to facilitate the funding of specialised medicines in South Africa.

MS. SUSAN LIN

SENIOR MANAGER: HEALTH POLICY DEVELOPMENT FOR MEDSCHEME HOLDING (PTY) LTD.

DR. MIRIAM BOLES

Position: Head of central administration of medical devices at Egyptian Drug Authority
Categories: meddevreg 2022

DR. MIRIAM BOLES

Head of central administration of medical devices at Egyptian Drug Authority

DR. BRENDA CLARE KITIMBO

Position: Assessor & Inspector working at the Uganda National Drug Authority
Categories: meddevreg 2022

Brenda Clare Kitimbo is a pharmacist with over a decade in regulatory undertakings. She has served with distinction as a Regulatory officer with Joint medical store a renown pharmaceutical distributor.

Prior to working at Joint Medical Store, Brenda worked as a general manager for a local production firm in Uganda. She has also served on the council of the pharmaceutical society of Uganda as an ex official council member and treasurer.

She has vast experience in pharmaceutical and medical devices supply chain management, Good manufacturing practices, quality management systems, submissions, strategies and agency interactions.

Brenda is a currently an assessor and inspector working at the Uganda National Drug Authority with present focus on medical devices.

She holds an M.S C. in Biotechnology innovation and Regulatory Sciences from Purdue-USA, an MBA from Makerere University -Uganda and Bachelors Degree in Pharmacy from University of Pune-India

DR. BRENDA CLARE KITIMBO

Assessor & Inspector working at the Uganda National Drug Authority

MR. CHRISTIAN NATALIS KAPINGA

Position: Drug Registration Officer at Tanzania Medicines and Medical Devices Authority (TMDA)
Categories: meddevreg 2022

He gained experience in regulation of both medicines, medical Devices, and invitro diagnostics specifically on Evaluation of dossiers for acquiring MA, conducting inspection of premises, conducting post marketing surveillance and vigilance, and conducting GMP inspection and quality audit against ISO 13485.

Christian has previously Worked as Supply Chain Advisor for PEPFAR HIV/AIDS Project at Bugando Medical Centre- A hospital in Eastern Northen part of Tanzania.

MR. CHRISTIAN NATALIS KAPINGA

Drug Registration Officer at Tanzania Medicines and Medical Devices Authority (TMDA)

DR. PLACIDE MUHAYIMANA

Position: Diagnostics and Medical Devices Registration Specialist at Rwanda Food & Drugs Authority
Categories: meddevreg 2022

Dr. Placide Muhayimana is currently working as a diagnostics and medical devices registration specialist at Rwanda Food and drugs authority.

He has a few years’ experience in the assessment of medical devices including IVDs as well as in the assessment of human medicinal products and is Rwanda FDA focal person in WHO for IVDs collaborative registration procedure.

He owns several certifications namely in basic fundamentals of IVD medical devices regulations from the World Health Organization and Assessment of Technical Files for Blood Screening in Vitro Diagnostic Medical Devices from Paul Erlich Institute among others. As for his educational background he holds a pre-med certificate in science and Russian language from Taras shevchenko university, after which he pursued a degree in general medicine from Bogomolets medical university and graduated as a medical doctor.

Currently, he is pursuing a masters’ degree in science of public health at the University of Suffolk.

DR. PLACIDE MUHAYIMANA

Diagnostics and Medical Devices Registration Specialist at Rwanda Food & Drugs Authority

MR. BATLEGANG DALLAS MOSWEU

Position: MANAGER MEDICAL DEVICES, DEPARTMENT OF PRODUCT EVALUATION AND REGISTRATION, AT BOTSWANA MEDICINES REGULATORY AUTHORITY (BOMRA) IN GABORONE – BOTSWANA
Categories: meddevreg 2022

Mr. Batlegang Dallas Mosweu is a Manager Medical Devices, in the Department of Product Evaluation and Registration, at Botswana Medicines Regulatory Authority (BoMRA) in Gaborone, Botswana.

Batlegang joined BoMRA in December 2020, having worked as a Biomedical Engineer at the Ministry of Health since August 2003. In his current role, he is overseeing the development and implementation of Medical Devices Regulatory Framework. This involves but not limited to:

  • Establishment of medical devices regulatory function in a stepwise approach, following the WHO Global Model Regulatory Framework for Medical Devices including IVDs (GMRF).
  • Development and implementation of medical devices & IVDs regulatory strategy and roadmap.
  • Registration of medical devices including IVDs (for both human and animal) to ensure of their safety, quality, and effectiveness before coming into the market.
  • Listing of medical devices including IVDs.
  • Assessment of Covid-19 related medical devices including IVDs coming into the market through an exemption process.
  • Collaboration with other internal Departments in development and implementation of:
    • Licensing, Inspection and Enforcement plan for medical devices including IVDs.
    • Laboratory testing plan for medical devices including IVDs.
    • Clinical trials and research plan for medical devices including IVDs.
    • Post Market Surveillance and materiovigilance of medical devices plan including IVDs.
  • Ensure effective implementation of collaboration action plans for the established Strategic Partnerships and Collaborations.

All these are achieved through continuous learning, stakeholder / shareholder consultations and stakeholder education on Medical Devices Regulation.

Batlegang holds a Degree in Biomedical Engineering from The University of Hartford in Connecticut, USA; Master’s in Project Management (specializing on Project economics and scheduling) from The University of Sidney in Australia; and various professional certificates in management and maintenance of specific medical devices, medical devices regulations, quality management system to medical devices etc.

Batlegang is a member of the Technical Working Groups aimed at harmonization of medical devices regulations and guidelines in the Region, Africa and for WHO working group on reviewing the GMRF for Medical devices including IVDs.

MR. BATLEGANG DALLAS MOSWEU

MANAGER MEDICAL DEVICES, DEPARTMENT OF PRODUCT EVALUATION AND REGISTRATION, AT BOTSWANA MEDICINES REGULATORY AUTHORITY (BOMRA) IN GABORONE – BOTSWANA

MS. SANDRA LIGIA GONZÁLEZ AGUIRRE

Position: MDRC PROJECT, TIER 2 LEADER
Categories: meddevreg 2022

Sandra Ligia has hold diverse management and directive positions at Regulatory Affairs, Sales, Marketing, Business Development and R&D for various countries in Latin America and Turkey.

Her experience covers from public institutions such as the National Institute of Nutrition in Mexico, to Global Companies such as Baxter, Danone and Johnson & Johnson Medical Devices where she held a Regulatory Affairs Senior Manager Position for Colombia and Mexico; she led the Regulatory Affairs Committee at AMID (Mexican Association of Innovative Medical Devices Industry) in 2016 and 2017.

She acted as Chair of AdvaMed’s Latin American Regulatory Affairs work since 2017 and is currently serving as Executive Secretary Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector, which unifies its 18 largest industry bodies in the Western Hemisphere and Lead of the Tier 2 Component of the Medical Device Regulatory Convergence, COVID-19 Project (MDRC).

Sandra has participated as a Faculty Member and speaker for several international events organized by the Regulatory Affairs Professionals Society (RAPS), International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and COFEPRIS/PAHO.

Sandra holds a bachelor’s Degree in Nutrition and Food Science and a Diploma on Product/Brand Management, both by Universidad Iberoamericana and a Diploma on Enterprise Top Management by IPADE (Instituto Panamericano de Alta Dirección de Empresas).

MS. SANDRA LIGIA GONZÁLEZ AGUIRRE

MDRC PROJECT, TIER 2 LEADER

MS. RANA CHALHOUB

Position: REGULATORY AFFAIRS DIRECTOR AT MECOMED
Categories: meddevreg 2022

Rana Chalhoub is an experienced Regulatory Affairs Professional with a demonstrated history of working in leading multinational medical devices companies such as Medtronic, Johnson & Johnson and Hospira Pfizer. During her career, Rana has managed to take over regulatory roles of increased responsibilities with an extended area coverage where she has built extensive knowledge of the regulations across MEA region. Rana holds a Laboratory Sciences degree along with a Regulatory Affairs Certification (RAC) from RAPS, along with a certificate in “Regulation: Theory, Strategy & Practice” from London School of Economics & Political Sciences (LSE).

In her current role as Regulatory Affairs Director at Mecomed, Rana is responsible for managing Regulatory Affairs-related responsibilities in MECOMED, the Medical Technology Association in Middle East and Africa, and works closely with Mecomed RA and executive teams on advancing Medical Technology regulations in the region.

She acts as the link between MECOMED members and external stakeholders such as Ministry of Health officials and Regulatory agencies with special emphasis on the prioritization of the RA needs of the MedTech industry.

MS. RANA CHALHOUB

REGULATORY AFFAIRS DIRECTOR AT MECOMED

MS. SALMA SALIM

Position: SENIOR RA PROGRAM MANAGER AT GE HEALTHCARE
Categories: meddevreg 2022

Salma Salim is an experienced Regulatory Affairs expert specialized in medical devices. She has worked for multiple medical devices companies for more than 12 years. During her career Salma has covered all the regulatory aspects in several regions: Europe, USA, Japan, China, Middle East and Africa. Salma is graduated from the Pharmaceutical School of Châtenay-Malabry (Paris XI – France) where she had her master’s degree in “Quality and Health products”.

In her current role as Senior Regulatory Affairs Program Manager at GE Healthcare, Salma is responsible for building RA strategy in Africa and covering all the regulatory aspects (Products registrations, Matereovigilance, Regulatory Intelligence…). She is also continuously interacting with the ministry of health representatives in the regulated countries within the region.

MS. SALMA SALIM

SENIOR RA PROGRAM MANAGER AT GE HEALTHCARE

DR. LYDIA MINA

Position: REGULATORY AFFAIRS MANAGER FOR THE REGION: AMTI (AFRICA MIDDLE EAST TURKEY INDIA) AT ABBOTT
Categories: meddevreg 2022

She is a RAPS (Regulatory Affairs Professional Society) member in USA and has a Diploma in e-CTD Master class by eXtedo E-Regulatory Affairs. Ms. Lydia is certified from Saudi council for Health Specialists & European Pharma Consultant group for Regulatory profession in Saudi FDA. In addition to her educational background, she has an MBA from Warnbough college, UK and a Diploma in Marketing & Salesmanship from American University in Cairo as well as a Bachelor of Pharmacy & Science, Alexandria University

DR. LYDIA MINA

REGULATORY AFFAIRS MANAGER FOR THE REGION: AMTI (AFRICA MIDDLE EAST TURKEY INDIA) AT ABBOTT

MS. SHIMAA SALAH

Position: ASSOCIATE DIRECTOR FOR AFRICA CLUSTER AT ALCON
Categories: meddevreg 2022

She’s a pharmacist with +15 years of experience in regulatory affairs in both private and governmental sector, generics & Innovative products on local and regional basis.

She’s experienced in fields of pharmaceutical &Medical Device industry (e.g. Regulatory compliance, supply chain, pricing and market access), with strong interpersonal skills reflecting presentation, communication, and analytical thinking with creative ability coupled with eagerness to learning and innovation, with high approach for problem solving, Conducting skillful negotiations, and establishing good relationships with Local Health Authorities.

Ms. Shimaa started her regulatory career as regulator in MOH in Egypt, currently it is EDA Egyptian drug authority in Egypt as she was occupied the position of planning & importation department head before I joined Alcon in 2011.

I’m graduated from faculty of pharmacy Cairo University and holding MBA from AAST in supply chain management.

In her current role in Alcon, she’s responsible for setting regulatory strategies for new product introduction, geo-expansion, licensing, as well as RA risk mitigation and regulatory compliance.

MS. SHIMAA SALAH

ASSOCIATE DIRECTOR FOR AFRICA CLUSTER AT ALCON

MS. NEREAH KISERA

Position: SENIOR TECHNICAL ADVISOR FOR THE REGULATORY SYSTEMS IMPROVEMENT PORTFOLIO OF THE MEDICINES, TECHNOLOGIES, AND PHARMACEUTICAL SERVICES (MTAPS) INITIATIVE OF THE MEDICINES SCIENCES FOR HEALTH (MSH)
Categories: meddevreg 2022

Nereah Kisera is a Senior Technical Advisor for the regulatory systems improvement portfolio of the Medicines, Technologies and Pharmaceutical Services (MTaPS) initiative of the Medicines Sciences for Health (MSH). She supports country programmes in the development and implementation legislation, guidelines, quality management systems, and information management systems to enhance the regulatory frameworks within the African continent. She also provides technical guidance for the continent-wide implementation of regulatory system harmonization initiatives. She is an experienced pharmacist with over 10 years’ experience in public health research the conduct of clinical trials in in Africa. Nereah holds a Bachelor of Pharmacy form the University of Nairobi in Kenya and A Master of Vaccinology and Pharmaceutical Clinical Development form the University of Siena in Italy.

MS. NEREAH KISERA

SENIOR TECHNICAL ADVISOR FOR THE REGULATORY SYSTEMS IMPROVEMENT PORTFOLIO OF THE MEDICINES, TECHNOLOGIES, AND PHARMACEUTICAL SERVICES (MTAPS) INITIATIVE OF THE MEDICINES SCIENCES FOR HEALTH (MSH)

MS. HELLA KHEMIRI GHORBEL

Position: Clinical Project Director for Mena and Africa at 1Med
Categories: meddevreg 2022

She Co-founder of the first Tunisian CRO, Senior project and regulatory affairs manager, with more than 15 years’ experience in clinical trials field.

Ms. Hella has worked on phase I to IV clinical trials in different therapeutic areas, in pharma-industry and medical devices, across Europe, Middle East & Africa region.

She has a demonstrated history of professional work with multinational sponsors in addition to other clinical services vendors.

At 1MED she Oversees the medical device evaluation and food supplements clinical trials projects in Mena, including daily Interactions with Medical devices manufacturers about MDR and IVDR as well as Team training and support.

MS. HELLA KHEMIRI GHORBEL

Clinical Project Director for Mena and Africa at 1Med

MS. LEA ATTALLAH

Position: QA/RA Associate Director, Emerging Markets at Zimmer Biomet
Categories: meddevreg 2022

Corporate Female too passionate about QARA Commercial and Medical Care with almost 9 years of high-tech experience, including a strong record in quality management systems, and registration projects for all risks of medical devices, IVDs/ biologics, and robotics.

I share best practices in PMPs, M&As, Corporate Strategic Thinking, Business Compliance, and Trade Compliance. This has allowed me to interact with counterparts in US/Americas, APAC, and EMEA. We have built together initiatives and delivered solutions across multiple areas, for efficient marketing strategies and processes effectiveness.

I continue to support Global DEI and the EMEA Leadership with the excellence delivery of culture growth and business transformation. This comes at the same time with my EMBA Program at ESCP Business School where I get the chance not just to explore and meet more than 15 cultures in at least 10 different new countries, but also to expand my creativity from the day-to-day usual tasks. This was pretty obvious having developed dashboard channels for the EMEA EM and Developed Markets for BREXIT, MDR, Demand Plans, and GTMM while assessing the risks in a user-friendly readiness.

Because of this dedication, I received more than 10 awards for being customer focused and for performing beyond expectations. Other significant professional achievements are being listed in the 2021 Med-Tech Women Advocates and moderating in regional events like the 2021 GCC Summit and the upcoming 2022 Afri Summit.

#dreambigger is my personal mantra. This has pushed me to never give up and continue innovating. One of the recent projects is the design of E-Touch, a multi-disciplinary polyclinic focused on both onsite services and omni services. I support the BOD creating new channels and exclusive strategies.

While I keep now focusing on my corporate lifestyle and writing my book, my other favorite times are for cycling, swimming, and reading over coffee. Besides life spirituality, I read about data analytics, brain functionality, and entrepreneurship/consulting.

MS. LEA ATTALLAH

QA/RA Associate Director, Emerging Markets at Zimmer Biomet

MR. LEONARD LAZARUS

Position: Regional Director at Biocair Africa and India, through the South African Clinical Research Association (SACRA)
Categories: meddevreg 2022

Leonard has been involved in clinical trial logistics for the past 30 years.  He has been serving as the Service Provider representative on the SACRA since 2014 Executive Committee. Over the past 30 years he has attended investigator meetings.

He has managed and controlled large clinical trials and assisted CRO’S in setting up complex clinical studies globally with TAT from 6 hours to 24 hours temperature controlled.

Leonard has done presentations to companies on handling, shipping and storage of clinical trial medication and blood samples.  He has assisted with documentation required for shipping medication and samples.

He has assisted with the required packaging and temperature monitoring devices and ensured that all regulations are met for shipping of samples / medication. He visits investigators / CRA’s and advises them on shipping requirements / packing / handling.  He facilitated 5-day training for Pathogenic Avian flu testing for WHO /CDC and, Webinars on Logistic and Regulatory challenges in Africa for Clinical Trials.

Leonard works with various regulatory boarders to bridge the gap with regulations with permits approvals for the Clinical Trial and Pharma Industry. He is an approved Trainer / Facilitator for IATA 6.2. Clinical storage Drug facility set up (Writing Site Master file /Sops) which is approved by Pharmacy Council / DOH.

His other duties include Setting up complex trials in Africa. Leonard is involved in business development on the African continent in the industry.

Leonard is an Independent Management Consultant / Import and Export specialist.

Leonard has really demonstrated his willingness to support researchers in South Africa and abroad

over many years. Recently he demonstrated tremendous commitment to the country’s COVID-19

response by ensuring that essential vaccines made it safely to their destinations.

Leonard Managed and facilitated the Covid 19 Vaccine rollout on the Sisonke Study. He was critical in

assisting us with the districts around the Covid-19 vaccine; without his leadership and hands on management of this process the successful execution of Sisonke would not have been possible.

MR. LEONARD LAZARUS

Regional Director at Biocair Africa and India, through the South African Clinical Research Association (SACRA)

MS. CAMILLA BORRINI, MSc

Position: Program Manager for EU Medical Device Regulation at Zimmer Biomet
Categories: meddevreg 2022

Camilla Borrini has a master’s degree in biology from University of Florence-IT, and Post-grad master’s degree in management from 24ORE Business School-IT. She has worked in the medical device (IVD & Non|VD industry) for over the past 8 years with managerial positions in QA & RA. Her current role since 2018 is with Zimmer Biomet as the Program Manager for EU Medical Device Regulation.

MS. CAMILLA BORRINI, MSc

Program Manager for EU Medical Device Regulation at Zimmer Biomet

DR. NAJDET MEZIANI

Position: Head of Regulatory Affairs for North and West Africa and Pharmacovigilance deputy at Bausch & Lomb.
Categories: meddevreg 2022

Pharmacist with over 14 years’ of working experience in the Pharmaceutical industry and in the fields of Medical Devices, Food Supplements, Cosmetics and retail pharmacies.

Currently occupying the position of Head of Regulatory Affairs for North and West Africa and Pharmacovigilance deputy at Bausch & Lomb.

Previously worked at GlaxoSmithKline (GSK) and at a local Algerian pharmaceutical company.

Strong experience in New Marketing Authorizations Applications and post market activities for more than 20 African countries, as well as labeling and Regulatory Intelligence. In addition to involvement in Distribution, Quality Assurance and Pharmacovigilance.

Passionate about projects management and regulatory strategies.

DR. NAJDET MEZIANI

Head of Regulatory Affairs for North and West Africa and Pharmacovigilance deputy at Bausch & Lomb.

MR. AHMAD HACHAMI

Position: REGULATORY AFFAIRS SPECIALIST AT JOHNSON & JOHNSON MEDTECH
Categories: meddevreg 2022

EDUCATION

2010: University of Bordeaux (FRANCE) : Master’s Degree: Biomaterial & Medical devices & Bachelor’s Degree: Biochemistry

WORK EXPERIENCE:

  • 2009-2011: vigilance Evaluator at ANSM (French Heath Authority)
  • 2011-2018: Regulatory Affairs & Quality Engineer: BBRAUN MEDICAL, Siemens Healthiness, THALES AVS France
  • From 2018 : Responsible for all aspect of regulatory activities for Maghreb, Ghana, Mozambique, and French West Africa, at Johnson & Johnson MedTech

Active member in local and regional Trade Associations (SNITEM, MECOMED, AMPDM).

Speaker at Dubai Pharmacy College via PRA Consultancy for Medical Device Regulation Masterclass MENA 2021 and 2022.

MR. AHMAD HACHAMI

REGULATORY AFFAIRS SPECIALIST AT JOHNSON & JOHNSON MEDTECH

MR. MONIR EL AZZOUZI

Position: CEO & Founder - Easy Medical Device
Categories: meddevreg 2022

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory affairs. He has worked for multiple Medical Device company where he acquired 15 years of experience. Within his experience he had to develop Quality and Regulatory affairs departments, obtain CE marking for Medical Devices, register products all over the world, deal with audits as Management Representative.

He has now created Easy Medical Device to support Medical Device companies that need help to place compliant products in the Market. He also educates the Medical Device community through his Blog, Podcast and Youtube channel. By educating everyone, we prevent issues to happen.

His motto “Would I give this product to a member of my family”. This helps him to take decisions.

MR. MONIR EL AZZOUZI

CEO & Founder - Easy Medical Device

DR. DAVID KARENYE

Position: Head of Regulatory Affairs, Quality Assurance & Compliance for B. Braun Melsungen AG subsidiary, Kenya
Categories: meddevreg 2022

is the Head of Regulatory Affairs, Quality Assurance & Compliance for B. Braun Melsungen AG subsidiary in Kenya; having previously worked as hospital pharmacist and a tutor at Makerere University pharmacy school.

David a registered pharmacist holds a B. Pharm, MSc. Epidemiology & Biostatistics -Makerere University and MBA (Strategic Management) – Kenyatta University.

He is passionate about the Health Products & Technologies (HPT) regularization with a bias to the emerging markets where policies are being developed for consumer protection on the focal pillars of Safety, Efficacy & Quality.

Dr. David is proactively involved in several healthcare industry associations such as the   Kenya Association of Pharmaceutical Industry (KAPI)- Chair of MDs & HPTs Committee as well as Medical Technology Industry Association of Kenya (MEDAK) – Chairperson.

DR. DAVID KARENYE

Head of Regulatory Affairs, Quality Assurance & Compliance for B. Braun Melsungen AG subsidiary, Kenya

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