MS. SIMONE RUDOLPH-SHORTT

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

Dr. Rima Nsheiwat

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. Lydia Mina

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. NOHA EL HARIRI

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.

Ms. Avanthi Govender Bester

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.

MR. MOHAMAD EL MOUALLEM

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. DARIO BELLUOMINI

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).

 

 

 

DR. RANIA SOLIMAN

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. MIRIAM BOLES

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.

 

Ms. Salma Salim

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.