About MedDevREG AfriSummit

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 regulations, through case studies, interactive presentations, and discussions. Attendees will learn which regulatory strategy is applicable for their products in which country in Africa.

WHY ATTEND

MEET NEW FACES

MORE THAN 150 PARTICIPANTS, among them your peers, advisers, clients and potential business partners

GET INSPIRED

A TWO-DAY PROGRAMME, filled with analysis, strategic ideas and exclusive new information from top speakers

INFORMATIVE PLATFORM

INTERACTIVE FORMATS, including industry leaders debates, interviews, discussions, analyses, Q&A, round tables and master-classes

2022 SPEAKERS

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

DR. DIMAKATSO T. MATHIBE

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

DR. BRENDA CLARE KITIMBO

Position: Assessor & Inspector working at the Uganda National Drug Authority
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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)
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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
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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
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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

SANDRA LIGIA GONZÁLEZ AGUIRRE

Position: : Lead Tier 2, Medical Device Regulatory Convergence, COVID-19 Project (MDRC)
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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).

SANDRA LIGIA GONZÁLEZ AGUIRRE

: Lead Tier 2, Medical Device Regulatory Convergence, COVID-19 Project (MDRC)

MS. RANA CHALHOUB

Position: REGULATORY AFFAIRS DIRECTOR AT MECOMED
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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

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

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

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.

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

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.

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.

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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