Dr. Hisham Stait has been serving as the Chairman of the Unified Procurement Authority (UPA), Egypt, since 2025. Prior to this role, he was the Vice Chairman of UPA since 2020, overseeing supply chain management for Egypt’s governmental healthcare sector, ensuring the procurement and distribution of essential medical supplies across the entire healthcare spectrum.

His leadership experience includes serving as CEO of El Gomhouria Co. for Chemicals and Pharmaceuticals (2018–2020), one of Egypt’s largest public-sector pharmaceutical and medical supplies companies.

Dr. Stait is a physician with a Master’s degree in Surgery from Ain Shams University, Cairo. Additionally, he holds an MBA in Supply Chain Management and International Trade Logistics, equipping him with a strong foundation in both medical and business management.

With 25 years of experience in healthcare, pharmaceutical manufacturing, FMCG, trade, and distribution, Dr. Stait has successfully led organizations both locally and internationally, driving efficiency, innovation, and strategic growth in the medical and pharmaceutical sectors.

Dr. Mona Al Moussli is the Co-Founder and Managing Director of PRA Consultancy, with over 20 years of expertise in pharmaceutical and medical device regulatory affairs. She has led key initiatives like the GCC RA Pharma Summit and the AfriSummit and developed the GCC Regulatory Affairs Course. Dr. Al Moussli also serves on several advisory boards, contributing to healthcare advancement and regulatory excellence in the region.

Dr. Najiba Al Shezawy is a Pharmacist and healthcare leader with over 20 years of experience in pharmacy practice, regulatory affairs, and public affairs. She is the Co-Founder and Managing Director of Professional Regulatory Affairs (PRA Consultancy), a leading healthcare regulatory consultancy in the Middle East since 2013.

To further uphold ethics and compliance standards in the industry, Dr. Najiba collaborated with Dubai Medical University, industry experts, and health authorities to establish the GCC Regulatory Affairs Course, the first-of-its-kind certification in the region that prepares graduates and professionals for new career opportunities in regulatory affairs.

Dr. Najiba began her academic journey with a Bachelor of Pharmacy from Dubai Pharmacy College for Girls and went on to earn a Master’s degree in EU Regulatory Affairs from Donau-Universität Krems, Austria.

In addition to her leadership roles, Dr. Najiba also shares her expertise in academia as a lecturer at Dubai Medical University, where she teaches Regulatory Affairs. Through this role, she equips future healthcare professionals with practical insights into regulations, ethics, and compliance, ensuring they are well-prepared to navigate the evolving pharmaceutical and healthcare landscape.

Her career started as a pharmacist at Dubai Hospital, followed by senior public affairs roles, before moving into consultancy and leadership. Alongside PRA, she serves as Managing Director of Hubplus Events, where she leads influential platforms such as the GCC Regulatory Affairs Pharma Summit and AfriSummit fostering collaboration between regulators, industry leaders, and young professionals.

Dr. Brayhan Kariuki is a Regulatory Officer at the Pharmacy and Poisons Board (PPB) of Kenya, working in the Department of Product Evaluation and Registration under the Medical Devices and In Vitro Diagnostics (IVD) Unit.

He is responsible for implementing regulatory measures that uphold the safety, efficacy, and quality of medical devices throughout their lifecycle.

Dr. Kariuki is particularly passionate about building an enabling regulatory environment by advancing regulatory systems through regional and global harmonization

Mr. Thabo B. Bokhutlo is a Medical Laboratory Scientist by profession. For the last 4 years, he has been involved in the Medical Devices including IVDs dossier assessments in the Department of Product Evaluation and Registration, at the Botswana Medicines Regulatory Authority (BoMRA) in Botswana. Prior to joining  BoMRA, he had been practicing as a Medical Laboratory Scientist under the Ministry of Health, Botswana for 4 years.  He holds a BSc in Medical Laboratory Sciences from the University of Botswana. He is passionate about the regulatory compliance of Medical Devices including In-vitro Diagnostics (IVDs). He has expertise in evaluating technical files and regulatory submissions to ensure compliance with local and international standards such as ISO 13485, and  ISO 14971. Skilled in assessing product safety, efficacy, and quality across various classes of medical devices including active devices and IVDs. He is committed to upholding regulatory requirements and contributing to patient safety through meticulous dossier assessment and regulatory compliance.

Mr. Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. 

Mr. Abebe Alamneh Kassahun has been working as a Senior Medicine Registration Expert at the Ethiopian Food and Drug Authority (EFDA) since 2016. He is also a Lead GMP Auditor for pharmaceutical companies and has visited more than 30 international manufacturers in different countries.

In addition, he is the Vice Chairman of the East African Regulatory Affairs Professionals Association (EARAPA) for the past two and a half years.

Mr. Arthur Sichivula is a highly experienced Digital Health Expert with over 19 years in the Information and Communication Technology sector, including 15 years specializing as a Digital Regulatory ICT Expert. He has led the design, development, and successful implementation of complex health regulatory systems, most notably the Integrated Regulatory Information Management System (IRIMS) for the Zambia Medicines Regulatory Authority (ZAMRA), where he has served as Head ICT since 2011.

His expertise spans ICT governance, cybersecurity, regulatory system development, ERP administration, digital health infrastructure, and disaster recovery.

He is a graduate in ICT Engineering, International Trade Facilitation, International Development, and Computing.

A fellow of the Information and Communication Technology Association of Zambia (ICTAZ) and a Professional Member of the British Computer Society (BCS), Mr. Arthur is widely recognized for his strategic leadership and ability to align digital innovations with regulatory and public health objectives. He continues to champion technology-driven transformation within regulatory authorities and the broader health sector across the region.

Dr. Frank N. Laban is a Senior Pharmacist with a B. Pharm and an MSc in Pharmacy Administration. He has over 17 years of experience as a medical product regulator at the Zambia Medicines Regulatory Authority (ZAMRA).

Currently, he is the Principal Registration Officer for Allied Substances at ZAMRA, where he oversees marketing authorization activities for medical devices, including IVDs. Throughout his career, he has collaborated with the WHO Prequalification (PQ) team on the assessment of IVDs as the focal person for the WHO Collaborative Registration Procedure (CRP) in Zambia.

At the continental level, he is an active member of the African Medical Devices Forum and serves as Vice Chair of the Medical Device Technical Committee of the AMDF, reflecting his dedication to advancing medical device regulation and healthcare safety across Africa.

Dr. Nancy Ngum is a Public Health Expert at the African Union Development Agency (AUDA-NEPAD) working under the African Medicines Regulatory Harmonization (AMRH) initiative. Her primary responsibility is focused on the operationalization of the African Medicines Agency (AMA), by supporting the coordination of the Regional Medicines Regulatory harmonisation programmes in Africa.

She is also leading the team of experts in Africa tasked to oversee the development of a Regulatory Information Management System (RIMS) and Regulatory Information Sharing Platform (RISP) for Africa. She is passionate about patient access to safe, quality and efficacious medical products and has embarked on conducting studies to assess the performance of Regulatory Review Systems with a view to improving patients’ access to Medicines in Africa.

Dr Ngum holds a Ph.D. in Regulatory Sciences from the University of Hertfordshire in the United Kingdom. Based on her passion, she has authored several publications in top medical journals and has published a book on “The Role of Regional Initiatives in the Operationalization of the African Medicines Agency.

Dr. Rachel J. Mujawimana is a seasoned pharmacist serving as an Inspector of Drugs at the Uganda National Drug Authority, with a focus on the regulation of medicines and medical devices. She holds an MSc in Pharmaceutical Sciences from Trinity College Dublin, a BPharm (Hons) from Universidad de Oriente, Cuba and an MBA from the Uganda Management Institute. Additionally, she has completed a Specialist Diploma in Medical Device Science at the University of Galway.

Rachel has extensive expertise in GMP inspections, quality management systems, and import/export verification, among other core regulatory functions. She is a member of the NDA Scientific Advisory Committee.

Rachel has contributed to policy discussions on Uganda’s new legislation regarding medicines and medical devices and is dedicated to advancing public health and ensuring that safe, high-quality medical products are accessible to all.

Dr. Khadijah is a Consultant Public Health Pharmacist with over twenty years’ experience working with the National Agency for Food and Drug Administration and Control (NAFDAC) across the Enforcement, Registration, and Establishment Inspection functions of the Agency.

She holds a B. Pharm., Master of Public Health, M.Sc. Regulatory Science and a Fellowship of the West African Postgraduate College of Pharmacists.

Dr. Khadijah Ade-Abolade is the Director in charge of the Vaccines, Biologics, and Medical Devices Registration and Regulatory Affairs Directorate of NAFDAC. She leads multidisciplinary teams in the Directorate that carry out all the reviews of technical documentation and other activities leading to the issuance of market authorization of vaccines, biologics, and medical devices, including emergency use authorizations and post-approval changes to registered products. She is also responsible for authorizing donations of vaccines and medical devices for humanitarian and public health needs.

She is a Lead Pharmaceutical Good Manufacturing Practice (GMP) Inspector and Quality Management Systems (QMS) expert, and she has led numerous GMP Inspection Teams to assess GMP compliance of domestic and foreign facilities, informing regulatory decisions on the facilities and the manufactured products.

She is a key participant in the technical working groups responsible for the development of the NAFDAC Medical Devices and GMP for Pharmaceutical Products Regulations and Guidelines, as well as ongoing review of these regulatory tools for continued adequacy. She is also a member of the NAFDAC QMS Steering Committee, which is responsible for monitoring and maintenance of the QMS of the Agency. She is also a member of the NAFDAC Strategic Planning and NAFDAC Greenbook Committees.

Dr. Khadijah Ade-Abolade is the focal person for NAFDAC in the ongoing efforts in preparation for effective regulation of locally manufactured vaccines in Nigeria. She is a member of the National Technical Working Group for Local Vaccine Manufacturing and the Lead of the Regulatory Sub-Team in the Group. She has represented the Agency at several local and international meetings and trainings geared towards preparedness for sustainable local vaccine manufacturing in Nigeria and the African continent. She represents NAFDAC in the Operations Team of the African Maturity Level 3 NRAs Reliance Mechanism as well as on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q1/Q5C Expert Working Group.

Ms. Sarah Cohen is the Executive Officer of SALDA as well as an Independent Consultant in the IVD/Laboratory Industry.

She has over 30 years’ experience in laboratory testing and research, specializing in IVDs and clinical trials.

She liaises with SALDA members and other stakeholders with regards to the MedTech Industry, emphasis being IVDs, and is solutions driven to assist the industry to navigate regulatory requirements, product importation, tenders, validation and health technology assessment.

She represents SALDA on the SAHPRA Regulatory Technical Forum .

Her passion is training, lecturing, and mentoring of clinical trial and laboratory personnel as well as upskilling the next generation of pharmaceutical sciences students for the MedTech industry.

She is a member of the Medical Devices Professionals Group and South African Clinical Trials Association

She obtained her Bachelor’s degree in Laboratory Management (Pretoria), Masters in Operations Management (Johannesburg) and MBA (Australia).

Dr. Marwa Said is a Regulatory Affairs Manager at Boston Scientific Corporation with extensive experience in medical device regulations across Africa and the MENA region.

She is actively engaged in advocacy for regulatory harmonization and capacity building, working closely with authorities and industry partners.

As a moderator of this session, Dr. Marwa will lead discussions on North Africa’s regulatory updates, fostering collaboration and insight among key stakeholders.

Rudolph-Shortt Consultancy cc t/a ISO Health SA, established in 2005, from years of experience in the regulatory, quality assurance, laboratory testing and production of medicines, medical devices, toiletries, and food products.

Ms. Simone Rudolph- Shortt is a qualified Industrial Pharmacist, with extensive experience in production and laboratory management including Quality Assurance and Regulatory Affairs. She provides professional consulting and training services, ensuring regulatory compliance and efficient productivity.

Mr. Rowland Sefakor is the Head of the Medical Devices Department at the Food and Drugs Authority, Ghana. With over ten (10) years of experience in medical devices analysis, he has been instrumental in helping the medical devices laboratory achieve accreditation to ISO 17025 in eight (8) scopes, including sampling by attributes according to ISO 2859. Mr. Rowland Sefakor holds an MSc in Safety Health and Environmental Management from the University of South Wales, United Kingdom.

Mr. Bill McMoil joined RAPS in 2017 as Chief Operating Officer and has served as Executive Director since April 2020. Since joining RAPS, McMoil has grown the organization from 26,000 to 35,000 members globally; staff from 40 to 60; and annual revenue by 57%. By expanding RAPS portfolio of products and services, he has championed innovative and effective solutions to address the diverse educational needs of the regulatory profession and has built a vibrant collaboration with the RAPS volunteer base (boards, committees, and chapters) in support of RAPS’ diverse, and geographically distributed community. RAPS’s European presence has expanded significantly during McMoil’s tenure, with membership and RAPS Euro Convergence event more than doubling. McMoil has also ensured that RAPS promotes itself as an ethical, neutral, and non-advocacy community for its regulatory members to connect, learn and share ideas.

Mr. Marc Chaillou is Head of Sales at Schlafender Hase. He has been working for the Pharmaceutical & Medical Devices industries for the last 13 years. Marc specialises in Regulatory Labelling and specifically how processes & technologies can reinforce, or compromise patient safety.

Dr. Karim Wahba is the Head of Regulatory Affairs and Trade Compliance for Middle East & Africa at Merck life science. With over 13 years of experience within regulatory management in medical device, life science and FMCG industries, Karim is a seasoned expert in navigating complex regulatory landscapes and ensuring compliance with international regulations. His expertise lies in strategic regulatory planning, risk management and building strong relationships with regulatory authorities.

Dr. 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.

Dr. Rana holds a Medical Laboratory Sciences degree along with a Regulatory Affairs Certification (RAC) from RAPS, and a certificate in “Regulation: Theory, Strategy & Practice” and another certificate in “AI: Law, Policy and Governance” 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 the different MedTech stakeholders such as Ministry of Health officials and Regulatory agencies to advance the Medical Technology Regulations in the region.

Dr. Rana is also co-chairing the GMTA (Global Medical Technology Alliance) Africa Working Group, and has been actively involved in the MDRC (Medical Device Regulatory Convergence) program for Africa.

Dr. Rana has also been engaged as a speaker and subject matter expert in several international and regional forums in Europe, Africa, Asia Pacific and the Middle East, on several topics such as Good regulatory practices, Reliance principles and Regulatory environment in MEA region.

Mr. Erik specialises in EU legal and regulatory frameworks for medical devices, digital health technologies, pharmaceuticals, and life sciences, with distinctive expertise in AI, software, in vitro diagnostics and personal data protection.

As a multilingual legal expert with extensive experience at the European Commission and several leading international law firms, he provides strategic counsel on complex regulatory and legal matters across medicinal products, medical devices, biotech and in vitro diagnostics sectors. His clients include the largest medical technology manufacturers and pharmaceutical companies in the world to start-ups as well as EU institutions, national governments and industry associations.

Erik’s expertise spans regulatory advice and litigation, commercial contracts, M&A transactions, and comprehensive regulatory strategy for medical technology, pharmaceutical, biotech and in vitro diagnostic enterprises.

An internationally recognised authority in life sciences regulation, Erik actively contributes to EU and national law and policy development through specialised committees at both national and EU levels. He is strategic advisor on law and policy development in medical technology for several EU institutions, governments and industry associations.

He serves as an arbitrator in medical device-related disputes and is regularly retained as an external expert in litigation.

Leveraging professional experience in Brussels, Amsterdam and Stockholm, Erik offers nuanced legal insights across multiple jurisdictions. Proficient in Dutch, English, French, German, Spanish and Swedish, he provides strategic, sophisticated, cross-border regulatory  and legal guidance for complex medical technology and life sciences challenges.

Dr. Marie Bouchra is Regulatory Professional with sixteen years of experience in Regulatory Affairs and over a decade of experience in the African Regulatory landscape, started her career with Johnson and Johnson in 2009, held various roles of increasing responsibilities.

Currently Regional Manager Regulatory Affairs and Policy for Middle East and Africa, specializing in advancing regulatory frameworks to enhance patient safety and market access for innovative medical technologies.

Driven by a deep passion for impactful initiatives specially for Africa region, Marie has worked extensively with both local and international trade associations on various advocacy topics to streamline regulatory processes across the continent. Through strategic collaborations, aiming to create a harmonized, efficient, quality-driven environment that empowers African countries to access cutting-edge medical technologies safely and efficiently.

Mr. Hilton Tommy Stevens has been with PSI (Population Services International) South Africa, an American based Medical Devices and Pharmaceutical Social Business, as the Head of the Regulatory Affairs and Quality Assurance. This role is responsible for the oversight and coordination of product registration and quality compliance for Sub-Saharan Africa regions. Currently also supporting New Product and business Development.

Mr. Hilton has a Bachelor of Pharmacy Honours qualification from Rhodes University, South Africa, and a Post Graduate Diploma in Health Economics from University of Cape Town.

Passionate about pharmacy affairs. As student he was elected as the President of the South African Pharmaceutical Students’ Federation (SAPSF), recently sat on the National Executive Committee of the Pharmaceutical Society of South Africa (PSSA), and currently sits on the National Executive Committee of the South African Association of Pharmacist in Industry (SAAHIP).

Mr. Dirk Gey Van Pittius has been in the Medical Device Industry since 1996, initially working on the commercial side of the business. Since 2005, he has focused on quality and regulatory affairs. Over the years, he has presented at various meetings covering both clinical and regulatory topics. He is a qualified external auditor for the ISO 13485 standard and led the First-in-Man (FIM) clinical trial in South Africa for a new vascular endoprosthesis developed by Medtronic.

Mr. Dirk holds an HDE (Education) from the University of the Witwatersrand and a postgraduate diploma in Strategic Management from George Washington University. More recently, he has developed a strong interest in post-market surveillance of medical devices and is currently involved in projects within this field.

Outside of work, Mr. Dirk is an avid mountain biker, enjoys the outdoors, and is actively involved in various animal welfare initiatives.

Ms Lydia Motlogelwa is a Medical Device Registration and Clinical Trials Manager at SAHPRA, she holds a Bachelor of Pharmacy degree .

She has more than 24 years of experience in a regulatory environment of health products. She is currently with SAHPRA in the Medical Device Registration and Clinical Trials Sub-unit.

Dr. Lydia is a Pharmacist with more than two decades of experience in pharmaceutical sales, market access, and regulatory affairs across the Middle East, Africa, Turkey, India, and the UK. Her career began in Egypt with Johnson & Johnson’s Janssen Cilag Pharma division, where she gained a deep understanding of commercial strategy in various roles for gastro, derma, neurology, and psychiatry products. She then joined Merck Sharp & Dohme in Kuwait, where she led the launch of Gardasil, followed by a position with MSD in the UAE, where she expanded her portfolio to include HIV and oncology products. In this capacity, she began working closely with health authorities, gaining insight into strategic market penetration, product classification, and distribution channel optimization.

Recognizing the critical role of regulatory affairs in shaping healthcare access and influencing outcomes beyond sales, she pursued her regulatory certification and was promoted to MSD’s Regulatory Department for specialty products across the Gulf region. She further expanded her regulatory expertise by joining the fast-growing FMCG company RB, where she collaborated with a team to build a regulatory framework for a diverse healthcare portfolio—including pharmaceuticals, medical devices, pesticides, and hygiene products—across the Middle East.

In her current role, Lydia is the Regulatory Affairs Regional Manager for Abbott-APOC, overseeing regulatory affairs for IVDs across METAP (Middle East, Turkey, Africa, and Pakistan), with extended responsibilities in the UK. This regional role is pivotal in navigating the evolving regulatory landscape shaped by MDR and IVDR, while aligning compliance with business growth strategies. She has also served as lead for the IVDR Tracker Working Group at Mecomed.

Dr. Fatma Wahdan is a seasoned Regulatory Affairs professional with over 18 years of experience spanning both government and industry roles. She began her career at Egypt’s Regulatory Authority before moving into the private sector, where she has held key local and regional positions at leading multinational pharmaceutical and medical device companies including Pfizer, Johnson & Johnson, and Medtronic.

Currently, Dr. Fatma leads the Regulatory & Quality team at Medtronic for Egypt, North, and West Africa. She is recognized for her strategic leadership, regulatory advocacy, and commitment to advancing regulatory excellence across diverse markets.

Mr. David Aden Mwakyoma is a Medical Devices Officer at the Tanzania Medicines and Medical Devices Authority (TMDA), with a professional background in pharmacy and biomedical engineering. With over eight years of regulatory experience, he specialises in the assessment of technical information for medical devices and in vitro diagnostics (IVDs) for marketing approval in Tanzania.

He has been involved in the development of national policies, regulations, and technical guidelines related to the regulation of medical products. As part of his regulatory responsibilities, he has conducted quality audits both locally and internationally, ensuring compliance with ISO 13485 standards.

He has served as the WHO Collaborative Procedure focal point for in vitro diagnostics in Tanzania and represents the country as the SADC regional focal person for the harmonisation of medical device regulation. He is also an active member of the GHWP Technical Working Group WG3 – Pre-market: Software as Medical Device.

Dr. Khalil Chemli is a pharmaceutical expert specializing in analytical chemistry and regulatory affairs. He is part of the Faculty of Pharmacy of Monastir, Tunisia, between 2013 and 2019, and went on to specialize in Analytical Chemistry from 2020 to 2024.

Currently, he serves as a Medical Device and Health Products Assessor at the National Agency for the Control of Medicines and Health Products (ANMPS). In this role, he is part of the department responsible for the technical control of medical devices and other health products, a critical step in the process of obtaining marketing authorization for consumption (AMC). His responsibilities include reviewing technical documentation submitted by importers, as well as the examination and analysis of product samples to ensure compliance with regulatory standards and public health safety.

Ms. Clare Birmingham is the Manager for International Affairs at MedTech Europe, the European trade association representing the medical technology industry. She works on international regulatory and market access issues, coordinating engagement with partners and policymakers across Africa, the Middle East, India, the UK, and Switzerland. Prior to joining MedTech Europe, Clare worked in the EU pharmaceutical sector in public policy and communications, and at the International Chamber of Commerce in Paris. She holds degrees in European Studies and Global Affairs, and in Political Science and Philosophy.

Dr. Miriam Boles currently serves as the Head of the Central Administration of Medical Devices at the Egyptian Drug Authority (EDA). She holds a Bachelor’s degree in Pharmaceutical Sciences from a well-established Egyptian university and a Master’s degree in Business Administration with a specialization in Supply Chain Management from the Arab Academy for Science, Technology & Maritime Transport (AASTMT).

With over two decades of experience in the medical device regulatory sector, Miriam has built a distinguished career in public service. She began her journey as a Medical Devices Registration Reviewer, later advancing to Senior Reviewer, and subsequently to Director of the Medical Devices Unit. In November 2020, she was appointed as the Head of the Central Administration of Medical Devices at the EDA.

In her leadership role, Miriam is dedicated to developing and implementing strategic plans for premarket regulation of medical devices and in-vitro diagnostics (IVDs), in alignment with the EDA’s mission to ensure the safety, quality, and effectiveness of medical devices in Egypt.

Key Achievements under her leadership include:

• Egypt, represented by the Egyptian Drug Authority, became the Vice Chairman of the African Medical Devices Forum (AMDF) in April 2025, winning the position for a three-year term.
• Egypt, represented by the EDA, became an Affiliate Member of the International Medical Device Regulators Forum (IMDRF) in October 2023.
• Egypt, represented by the EDA, became a Permanent Member of the Global Harmonization Working Party (GHWP) in December 2023.
• The Egyptian Drug Authority joined the African Medical Devices Forum (AMDF) in February 2024.
• Enhanced localization of numerous medical devices and equipment.
• Implemented Unique Device Identification (UDI) for all medical devices circulating in the local market in October 2022.
• Established “MeDevice”, an online platform for automating administrative processes and enabling electronic archiving in 2021.
• Developed a national procedure to regulate the importation and circulation of laboratory and IVDs — the first of its kind in Egypt in 2021.
• Issued comprehensive regulatory guidelines for premarket approvals, unique device identification (UDI), and labeling requirements.

Dr. Miriam is recognized for her dedication, professionalism, and passion for regulatory excellence. She values teamwork, positivity, and motivation through achievement. Her interests include data analysis, problem-solving, and continuous learning — particularly in staying updated with global developments in medical device and IVD regulations.

Dr. Noha is a Strategic Business Consultant and industry expert with more than 22 years of experience in the regulatory field.

She served as the General Manager of the General Administration of Medical Device Registration at the Egyptian Drug Authority (EDA) from 2020 to 2025, where she contributed significantly to the development of numerous regulations and guidelines for medical device registration. She also participated as a member of the IMDRF Working Group.

During her tenure at the EDA, she was responsible for the localization project of medical devices, equipment, and IVDs, where she played a key role in establishing many new factories and had a substantial impact on supporting the industry.

Dr. Marie Emad is a seasoned regulatory affairs specialist with over 12 years of experience in the medical device sector. In her current role, she leverages her expertise in medical device registration, variation assessment, and regulatory compliance to support the availability of safe and innovative healthcare technologies in Egypt.

Dr. Emad holds a Bachelor of Pharmaceutical Sciences and has dedicated her career to strengthening regulatory systems and promoting regulatory excellence. Prior to joining BD, she served as the Manager of the Evaluation Unit – Administration of Medical Devices Variation at the Egyptian Drug Authority (EDA). In this role, she was responsible for evaluating medical device variations, developing guidance documents, and contributing to the implementation of regulatory policies.

Her unique experience across both regulatory authority and industry environments allows her to combine deep technical knowledge with practical insights, making her a valuable contributor to advancing healthcare regulation in Egypt and beyond.

Dr. Maria is a dedicated pharmacist specialized in the Regulatory Affairs field with more than a decade of experience in the MedTech sector, progressing from local roles to regional positions within top global medical device organizations. She has a proven track record of ensuring compliance with industry regulations and guidelines across Emerging Markets, supporting the registration and access of medical devices.

Dr. Arame Mbengue holds a Doctorate in Pharmacy from Cheikh Anta Diop University of Dakar (2019) and has six years of experience in the field of pharmaceutical regulation within Senegal’s pharmaceutical regulatory authority.

She also holds two master’s degrees: a Master’s in Pharmaceutical Inspection from the Institute of Pharmaceutical Sciences (ISMED), Cheikh Anta Diop University (UCAD), and a Master’s in Physicochemical Analysis and Quality Management of Health Products and Food from the same university.

In addition, Dr. Mbengue obtained a University Certificate from the International Course on Medical Devices: Practical Knowledge and Management at Joseph Ki-Zerbo University in Burkina Faso (2021).

Dr. Mbengue also currently serves as the WHO CRP DMDIV Focal Point.

Dr. Salah Eldin Allam is a seasoned pharmaceutical regulatory expert with over 18 years of experience in drug inspection, market surveillance, and regulatory compliance. As the Manager of Pharmacy and Warehouse Inspection at the Egyptian Drug Authority (EDA), he leads strategic initiatives to combat substandard and falsified medical products (SFMPs), oversees nationwide inspections, and develops regulatory frameworks aligned with WHO standards.

Key Achievements:

• Regulatory Leadership: Spearheaded Egypt’s achievement of WHO Maturity Level 3 (for vaccines and pharmaceuticals) as the focal point for market control and inspections.

• Global Collaboration: Serves as Egypt’s focal point for the WHO Global Surveillance and Monitoring System (GSMS) and actively contributes to WHO guidelines on SFMP prevention.

• Capacity Building: Trained 400+ inspectors and international counterparts (e.g., Libyan NRA) on post-market surveillance (PMS) and Good Distribution Practices (GDP).

• Policy Development: Authored Egypt’s risk-based sampling guidelines, GSDP standards, and SOPs for PMS, enhancing regulatory oversight.

• Digital Transformation: Pioneered track-and-trace systems and digital tools for market surveillance in Egypt.

Education & Training:

• Bachelor of Pharmacy, Ain Shams University (2005)

• Certified in WHO Global Benchmarking Tool (GBT), ISO 9001:2015, Supply Chain Security, and Cold Chain Management.

Recent Engagements:

• Member, WHO Member State Mechanism on SFMPs (Working Group on Regulatory Capacity).

• Contributor, AUDA-NEPAD subcommittee on market surveillance (Africa-wide guidelines).

Dr. Doaa Saeed has been serving as the General Director of the General Administration of Medical Devices Registration at the Egyptian Drug Authority (EDA) since September 2025.

She earned her Bachelor’s degree in Pharmaceutical Sciences in 2005 and began her professional journey with the Central Administration for Pharmaceutical Affairs – Medical Device Registration in 2006. Over the years, she has played a vital role in shaping Egypt’s medical device regulatory landscape, contributing her expertise to the establishment of the EDA in 2020.

Throughout her nearly 20-year career, Dr. Saeed has held various leadership positions within the medical devices sector, progressing from Rapporteur of the Registration Committee to Manager of multiple departments, and now to her current directorial role.

In 2024, she earned a Project Management Certification from the American University in Cairo (AUC) School of Business, further strengthening her leadership and strategic management capabilities.

Dr. Youstina Nabil is a Senior Reviewer in Local Medical Device Registration at the Egyptian Drug Authority (EDA). She is responsible for reviewing technical documentation of non-CE medical devices in accordance with EU regulatory principles. Through her work, she contributes to advancing local innovation and strengthening the regulatory framework that supports the growth of Egypt’s medical technology sector.

Dr. Saida Foughalia is the Deputy Director at the Directorate of Medical Device Registration within the Algerian Ministry of Pharmaceuticals.

A Principal Physician, she previously served as Head of Materiovigilance at the National Centre for Pharmaco- and Materiovigilance, and as Project Manager for “Patient Safety Related to Medical Devices” from 2012 to 2015.

Dr. Foughalia is deeply engaged in strengthening the national regulatory framework for medical devices and promoting patient safety, quality, and performance within the healthcare system.

She represents Algeria at the AfriSummit, a continental platform dedicated to advancing medical device regulation in Africa.

Dr. Sara Emad Girgis is a Clinical Pharmacy specialist with a Bachelor’s degree in Pharmaceutical Science and a Diploma in Clinical Pharmacy from Ain Shams University. Currently serving as the Imported In Vitro Diagnostic Listing Unit Manager at the Egyptian Drug Authority. She leads the registration and regulatory oversight of multiple in vitro diagnostic (IVD) devices, ensuring full compliance with EDA standards. 

An active member of several international and national regulatory bodies, including the IMDRF IVD Clinical Evidence Working Group, the GHWP Working Group 2, and the Medical Laboratories and In Vitro Diagnostics Committee of the Egyptian Organization for Standards and Quality (EOS).

Dr. Radwa Abdelkafy is the Head of Regulatory Affairs Africa at Baxter International. She is a seasoned Regulatory Affairs professional with over 15 years of experience across Middle East, Africa, and Turkey. She has extensive expertise in both the pharmaceutical and medical device sectors.