Bringing together regulators and industry leaders to streamline medical device and IVD access across Africa

Over 15 years of experience in regulation, including assessments of Medicines, vaccines, medical devices, diagnostics, and Emerging Technologies.
Regulatory Inspections, including Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) inspections, Market Surveillance, and Pharmacovigilance,

Technical areas of expertise include:

• Providing scientific and technical expertise on registration of Health Products;
• Reviewing scientific and regulatory assessments of Marketing Applications;
• Supporting reliance and joint review approaches;
• Advising on regulatory standards, guidelines, and best practices;
• Contributing to continental capacity strengthening;
• Supporting emergency regulatory preparedness where relevant

Paulyne Wairimu, Chair of the African Medical Devices Forum (AMDF) under the African Medicines Agency, also serves as the Head of the Medical Devices and IVD Cluster at the Pharmacy and Poisons Board, Kenya’s National Regulatory Authority. With extensive experience in regulatory systems development and health systems strengthening with Specialized Expertise in Medical Technologies, Public Health, and Global health diplomacy; Paulyne is a dedicated advocate for regulatory harmonization and convergence across Africa and globally.

Dr. Edwin Kojo Ogara is a pharmacist and global health specialist with over 18 years of experience spanning pharmaceutical regulation, public health systems, quality assurance, pharmacovigilance and health-product supply chains. He currently serves as Essential Drugs and Medicines Officer and Technical Focal Point for Health Products and Technologies at the World Health Organization (WHO) Kenya Country Office, providing technical support to governments and partners to strengthen regulatory systems and access to safe, quality-assured medicines, vaccines and other health technologies.

His work has contributed to Kenya’s advancement toward WHO Global Benchmarking Tool (GBT) Maturity Level 3, including regulatory institutional development, audits and quality-assurance capacity strengthening. He is also engaged in local vaccine and biologics manufacturing readiness, including collaboration with the Kenya Biovax Institute and the WHO mRNA Technology Transfer Programme.

Previously, Dr. Ogara served as GMP Quality Assurance Manager for East Africa with a multinational pharmaceutical company, supporting quality systems across Sub-Saharan Africa, and subsequently advised pharmaceutical start-ups on operations, policy and strategy. His professional focus is on regulatory systems strengthening, resilient health-product ecosystems, local manufacturing, pandemic preparedness and health security in Africa and across the Globe.

Dr. Zivanai Antony Makoni is Head of the Evaluations and Registration Division at the Medicines Control Authority of Zimbabwe (MCAZ), where he leads marketing authorisation of human, veterinary and complementary medicines and deputises for the Director General.
He is MCAZ’s WHO Global Benchmarking Tool focal point for marketing authorisation, guided the Authority’s advancement from Maturity Level 1 to ML3, and now leads its work towards ML4 through the publication of Public Assessment Reports and Summaries of Product Characteristics. In 15 years of regulatory science he rebuilt MCAZ’s registration system around measurable performance: the KPI-driven framework he introduced in January 2024 delivered 74% more medicines registered, a 77% rise in new submissions and a 122% increase in application revenue. He also led the digitisation of MCAZ’s regulatory processes, culminating in the Authority’s in-house online submission and tracking platform — work recognised with the 2025 MCAZ Corporate Values Award for Innovation.

Continentally, he chaired the African ML3 NRAs Operations Team that developed a reliance mechanism aligned to the African Medicines Agency, AMRH for Africa.

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.

Dr. Rachaa is a Regulatory Affairs Pharmacist at ANMPS with 5 years of expertise. Specializing as a Pharmacist Evaluator for Marketing Authorization (AMM) applications, Dr. Rachaa also manages the classification of medical devices and borderline products and oversee regulatory compliance for dental products.

Dr. Rachaa is dedicated to ensuring health product safety and compliance.

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.

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. Vedaste HABYALIMANA is the Head of the Drugs Department at the Rwanda FDA since April 2024. He brings with him a wealth of experience, having previously held the position of head of the former Food and Drugs Assessment and Registration Department, as well as serving as the Quality Assurance Analyst at Rwanda FDA.

Dr. Vedaste is highly proficient in the development and coordination of Quality Management Systems (QMS) and has played a key role in the process of certifying Rwanda FDA’s QMS to the ISO 9001:2015 standard. He has also been involved in the WHO benchmarking for maturity level 3 (ML3) for Rwanda FDA, an essential requirement for the regulation of Medicines and Vaccine manufacturing and Vaccine lot release.

With over 15 years of practical experience in Quality Assurance and Quality Control of essential medicines and health commodities, Dr. Vedaste has held significant roles at the Pharmaceutical Laboratory of Rwanda (LABOPHAR) and the Rwanda Biomedical Center / Medical Procurement and Production Division (currently Rwanda Medical Supply Ltd.).

Dr. Vedaste holds a Bachelor’s degree in Chemistry, as well as a Master’s degree and a Ph.D. in Biomedical and Pharmaceutical Sciences – with a specialization in Pharmaceutical Analytical Chemistry.

Dr. Vedaste actively contributes to academia as a part-time Lecturer and Theses Supervisor in the Pharmacy Department at the University of Rwanda / College of Medicine and Health Sciences (UR-CMHS), and at the EAC-Regional Center of Excellence for Vaccines, Immunization and Health Supply Chain Management (UR-HSCM).

Additionally, he focuses his research on the Quality of medicines and other health commodities, Systems compliance with international standards/guidelines and application of best practices (GxP), among other critical areas.

Dr. Khadijah O. Ade-Abolade is a Consultant Public Health Pharmacist with almost twenty-five 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., Masters and PhD in 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 Project Team Lead for the WHO Maturity Level 3 for Medical Devices in Nigeria and 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

A Doctor of Pharmacy and sworn pharmaceutical inspector, Dr. Fadoua OUDRHIRI is a public health specialist with over 12 years of experience in health products, particularly in regulation, evaluation, and authorization.

Dr. Fadoua’s professional background has enabled her to develop strong expertise in the regulatory assessment of health products and the implementation of requirements related to their quality, safety, and efficacy.

She currently serves as Head of the Division of Evaluation and Authorization of Health Products at the Moroccan Agency for Medicines and Health Products (AMMPS), where she oversees medical devices, in vitro diagnostic reagents, cosmetics, and food supplements, leading a team of approximately 50 evaluators.

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.

Prof. Mazyanga Lucy Mazaba is an award-winning Zambian public-health leader, epidemiologist and virologist with nearly 30 years of experience in health-system strengthening, disease surveillance, epidemic preparedness, policy engagement and strategic communication.

She currently serves as Regional Director of the Africa Centres for Disease Control and Prevention Eastern Africa Regional Coordinating Centre, providing strategic leadership and coordinating public-health priorities across 14 African Union Member States.

Prof. Mazaba was a member of the inaugural leadership team that established and operationalised the Zambia National Public Health Institute, where she subsequently held senior Director positions. She also established and served as the inaugural Editor-in-Chief of The Health Press Zambia, creating an influential platform for translating scientific evidence into policy, practice and public understanding. Earlier in her career, she served with the World Health Organization for 11 years, contributing to surveillance, immunisation, laboratory systems and outbreak response.

She holds a Doctor of Science in Public Health and a Master of Science in Epidemiology. She is an Adjunct Professor at Amref International University, a Fellow of the Academy of Public Health, and an accomplished author and editor with more than 180 scientific publications, editorials and book chapters.

Dr Mazaba has received numerous accolades and recognitions from professional, academic, corporate and civic organizations for her contributions to public health, scientific communication, leadership and community service. Her formal awards include the Stanbic Bank Zambia Anakazi Women in Health Award and the Outstanding Health Communications Award at the Zambia Health Research Conference.

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.

Ezekiel Mukanga is a distinguished Artificial Intelligence Expert and Digital Transformation Leader. He has been leading the Digital and Data Transformation workstream for the African Medicines Agency (AMA), a specialized institution of the African Union. Ezekiel also chairs the SADC (ZAZIBONA IMS Technical Committee).

He has held several senior leadership roles across key national institutions, including heading ICT departments at the Medicines Control Authority of Zimbabwe (MCAZ) which saw MCAZ reach WHO ML3 and also benchmarked for ML4 , prior to joining MCAZ , Ezekiel lead the ICT Divisions of the Zimbabwe Stock Exchange (ZSE), the Zimbabwe Investment and Development Agency (ZIDA), and Akribos Financial Investments.

With over 12 years of regulatory experience, he has developed systems for regulators from the unique vantage point of having served as a regulator himself.

Batlegang Dallas Mosweu is the Manager Medical Devices at the BoMRA. Joining BoMRA in December 2020, he brings extensive biomedical engineering expertise from his prior role at the Ministry of Health, where he served from 2003.

Batlegang leads the development and implementation of BoMRA’s Medical Devices Regulatory Strategy and Roadmap. He oversees both basic and expanded levels of regulatory control across all medical device functions, including product registration, special exemptions, licensing, inspections, clinical trials, vigilance reporting and post-market surveillance. He plays a key role in driving regional and international harmonization and convergence of medical devices regulations, standards, and requirements, aligning BoMRA with global frameworks such as IMDRF, GHWP, ISO, and WHO. Additionally, he is an expert in navigating the BRIMS platform for medical device registration, classification, and compliance.

Education & Qualifications:

• MSc in Project Management – University of Sydney
• BSc in Biomedical Engineering – University of Hartford
• Certificate in Medical Devices Regulatory Affairs – RAPS
• Certificate in Management Development Programme – University of the Witwatersrand
• Regulatory & Quality Certificates
• Professional & Technical Service Certificates
• Trained in WHO GBT+MD for evaluation and strengthening of regulatory systems.

Neema Joseph Nagu is a Senior Medical Devices Officer at the Tanzania Medicines and Medical Devices Authority (TMDA), with over 15 years of experience in the health sector, including four years specializing in medical device regulations.

She leads coordination with manufacturers, marketing authorization holders, importers, distributors, healthcare facilities, and development partners to strengthen medical device regulation in Tanzania. Her work focuses on post-market surveillance, stakeholder capacity building and coordination of the safe disposal of unserviceable medical devices.

Ms. Nagu has led two notable initiatives: establishing a digital data collection system for post-market surveillance of medical equipment and coordinating Tanzania’s first national disposal of unserviceable medical equipment. These initiatives have strengthened regulatory oversight and contributed to the safety, quality, and performance of medical devices.

She holds MSc in Applied Epidemiology, MSc in Pharmaceutical Analysis, and a Bachelor of Pharmacy. At the 6th AfriSummit 2026, she aims to share Tanzania’s regulatory experiences and learn from regional best practices to advance equitable access to safe, quality, and affordable medical devices across Africa.

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).

Nourhan El Naggar is a Medical Device Regulatory Affairs professional with more than eight years of experience in medical device regulation, scientific evaluation, and regulatory policy development. She currently serves as Manager of the Scientific Evaluation Unit at the Egyptian Drug Authority (EDA), where she leads the scientific assessment of medical devices and contributes to the development of regulatory frameworks and market authorization pathways.

Her expertise includes medical device classification, conformity assessment, regulatory reliance, international regulatory benchmarking, and medical device localization and local manufacturing strategies. She is also pursuing a Master’s degree in Quality Management. Nourhan is passionate about regulatory harmonization, strengthening local manufacturing capabilities, and advancing medical device regulatory systems across Egypt and Africa

Alex Gisagara is a Regulatory Harmonization Expert at the East African Community (EAC) Secretariat. He holds a Master’s degree and a PhD in Biotechnology Innovation and Regulatory Sciences and teaches in the Master’s Programme in Regulatory Science at the University of Rwanda.

Alex previously served as Head of Department at the Rwanda Food and Drugs Authority (Rwanda FDA), where he was responsible for Inspection and Safety Monitoring. He also represented Rwanda in the EAC Medicines Regulatory Harmonization (MRH) Programme from 2012 to 2018, contributing to regional efforts to strengthen and harmonize medicines regulatory systems.

He led the Rwanda FDA team during the PIC/S pre-accession assessment initiated in 2020 to assess compliance with the PIC/S recommendations on quality system requirements for pharmaceutical inspectorates.

Alex has also participated in assessments of Rwanda FDA and the South African Health Products Regulatory Authority (SAHPRA) with the World Health Organization (WHO), serving as an assessor and applying the WHO Global Benchmarking Tool (GBT) for the assessment of regulatory systems for vaccines and medicines.

Mr. Nyambe Lyoko is a seasoned pharmacist and regulatory professional with over 14 years of experience in medicines regulation. He currently serves as Director of Marketing Authorisation at the Zambia Medicines Regulatory Authority (ZAMRA), where he leads the registration of medicines and allied substances, authorisation of the conduct of clinical trials and vigilance activities.

His expertise spans marketing authorisation, clinical trials, and pharmacovigilance, contributing to strengthened public health systems in Zambia. Under his leadership, ZAMRA has advanced key initiatives, including the clearance of backlog marketing authorisation applications, the adoption of regulatory reliance mechanisms to improve access to quality-assured medicines, and the implementation of track and trace for medicines in Zambia.

Mr. Lyoko is passionate about regulatory science, innovation, and strengthening pharmaceutical supply chains to ensure access to safe and effective health products across Africa.

Ravi is the Deputy Director of FDA’s Office of Global Policy and Strategy, which is the lead for U.S. FDA’s interactions with international counterparts, including for regulatory cooperation initiatives. He also manages the FDA’s foreign offices in China and Europe (Belgium, Netherlands, United Kingdom), Latin America (Costa Rica, Mexico, Chile, Argentina), India, and Rwanda

Birikunzira Shabani Jean Baptiste is a Pharmaceutical Regulatory Professional and Pharmaceutical Production and Supply Chain Strategy Specialist at Rwanda Food and Drugs Authority (Rwanda FDA), with over 13 years of experience spanning medicines regulation, pharmaceutical manufacturing, supply chain management, quality systems, and regulatory strategy.

He holds a Bachelor of Pharmacy (Honours) and a Master of Science in Health Supply Chain Management from the University of Rwanda and is currently pursuing a PhD in Pharmaceutical Sciences at the University of Rwanda. His doctoral research focuses on assessing the Pharmaceutical Traceability Framework for Safeguarding Medicine Quality in the Rwandan Market.

At Rwanda FDA, Jean Baptiste has held progressively responsible roles in GMP inspections and establishment inspections, and pharmaceutical production and supply chain strategy. In his current role, he contributes to national initiatives aimed at strengthening pharmaceutical production, supply-chain integrity, digital transformation, technology transfer, and regulatory systems. He has actively advanced pharmaceutical traceability and the use of GS1 Global Standards, including aligning the National Product Catalogue with Rwanda’s national vision and strategy for pharmaceutical traceability.

Jean Baptiste combines regulatory expertise with practical experience in pharmaceutical supply-chain management, having previously served as a hospital pharmacist and Deputy Director at a regional medical store. He is a certified ISO 9001:2015 Quality Management Systems Lead Auditor. He has undertaken professional training in GMP, GSDP, vaccine manufacturing, intellectual property management, technology transfer, health supply chains, and regulatory leadership.

He is passionate about strengthening African pharmaceutical regulatory systems, advancing local production, and leveraging digital technologies and regulatory innovation to improve access to safe, quality-assured medicines across Africa.

Dr. Solomon Koech is a Senior Regulatory Officer at Pharmacy and Poisons Board(PPB) Kenya. Solomon works at the Department of Product Evaluation and Registration under the Medical devices and In-vitro diagnostics unit. He is involved in technical evaluation of Medical devices and IVD applications for Marketing Authorization.

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 AfriSummit and the GCC Regulatory Affairs Summit 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.

Sebastian Neuwirth is Head of Government Solutions at Antares Vision Group, where he holds executive responsibility for the Group’s government business. His remit spans strategy, commercial leadership and the delivery of national digital health and regulatory platforms, with a focus on pharmaceutical and medical device traceability and digital transformation. Appointed to the role in 2024, he leads the Group’s engagement with government authorities worldwide.

Working at the intersection of regulation and technology, Sebastian supports authorities in modernising how healthcare products are registered, imported and monitored throughout their lifecycle. His work connects regulatory policy with programme design and delivery, helping governments move from fragmented, paper-based processes to integrated digital systems that support national oversight.

He works directly with regulators to shape implementation strategies that reflect both policy ambitions and operational realities. This includes phased deployment, industry readiness, legacy data migration and integration with customs and other government platforms. His approach draws on experience across the full delivery lifecycle, from defining programme requirements to coordinating complex implementations in highly regulated markets.
Based in Manama, Bahrain, Sebastian oversees Antares Vision Group’s engagement with Bahrain’s National Health Regulatory Authority on the MADAR and TATABU programmes, alongside other government projects across the region and Africa.

He brings nearly a decade of experience in healthcare and life sciences. Before assuming his current role, he built and scaled the Group’s global partner integration capability for pharmaceutical serialisation and held successive leadership positions in Project Management and Professional Services. These included responsibility for the global professional services delivery portfolio for enterprise programmes and the implementation of complex traceability, serialisation and compliance solutions.

Earlier in his career, Sebastian worked in management consulting and private equity, focusing exclusively on the technology sector.

Ms. Nataliya Deych is Chair of the MedTech Europe Middle East and Africa Working Group and Vice President, Regulatory Affairs EMEACLA at Edwards Lifesciences.

Based in the Geneva–Lausanne region of Switzerland, she holds a Master’s degree in Biotechnology and leads the development and implementation of regulatory strategies across Europe, the Middle East, Africa, Latin America and Canada. In her current role, she guides the organisation through evolving regulatory environments and capability investments, with a particular focus on regulatory and clinical pathways for marketing authorisation and patient access. Her work also covers risk-benefit approaches to clinical evidence and Real-World Evidence, particularly for therapies addressing unmet medical needs.

Prior to joining Edwards Lifesciences, Ms. Deych served as Senior Director, Regulatory Affairs EMEA at Medtronic and led Regulatory Affairs at Colgate-Palmolive Europe Sàrl in Basel, Switzerland. Earlier in her career, she held management positions across Research & Development, Manufacturing Process Management and Quality Assurance at Unilever. She has also worked as an independent consultant to the cosmetics industry, including in the area of alternative toxicological methods.

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.

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.

Dr. Janki Chauhan, Senior Manager of Regulatory Affairs and Pharmacovigilance at Surgipharm Limited, a DP World company, and a practicing Regulatory Pharmacist with extensive experience in pharmaceutical and medical device regulation.”

“Dr. Janki Chauhan holds a Doctor of Pharmacy (Pharm.D.) degree, supply chain diploma, leadership management, ISO 9001:2015 lead auditor by IRCA and serves as the Qualified Person for Pharmacovigilance (QPPV). She is also the Chairperson of the Medical Technology Industry Association of Kenya (MEDAK), where she actively advocates for regulatory harmonization, patient safety, and improved access to quality healthcare products.” In addition, she is the vice chair of the supply chain committee at KHF, an active member of KAPI and PSK.

“With expertise spanning regulatory affairs, quality assurance, pharmacovigilance, supply chain compliance, and medical device regulation, she has successfully led numerous market access initiatives, and compliance programs that have enhanced patient access to safe and effective health products throughout the region.”

Managing Director | Strategic Healthcare Executive | Board Director

Robert Mayama is a strategic healthcare executive with over 15 years of leadership experience across the East African medical technology and pharmaceutical sectors. He currently serves as Managing Director of Autosterile East Africa Limited, a Medical Device manufacturing and Health Products and Technologies (HPT) distribution company.

Prior to his current role, Robert led Business Development, Marketing, and Sales for East Africa at B. Braun Medical. His experience spans medical device manufacturing and distribution, commercial strategy, market development, and corporate governance, giving him a practical perspective on the opportunities and challenges facing Africa’s Medical Technology industry.

Robert serves on several boards, including the Medical Technology Industry Association of Kenya (MEDAK), Sawa Sacco, and Undugu Empowerment Programs (UEP). He holds an MBA in Marketing from Kenyatta University, a Bachelor of Business Management from Mount Kenya University, a Diploma in Pharmacy from The Eldoret Polytechnic, and Level 7 Advanced Marketing credentials from the Chartered Institute of Marketing (CIM), UK. He is currently pursuing a Doctorate in Business Administration (DBA).

His experience across Manufacturing, Industry representation, and Commercial strategy positions him to contribute meaningfully to discussions on strengthening Local Manufacturing, advancing Africa’s Medical Device industry, and aligning industry priorities to drive sustainable growth and access.

Sarah Cohen is the Strategic Executive Officer of SALDA and an independent consultant in the IVD and laboratory industry.

Sarah has more than 30 years of experience in laboratory testing and research, specialising in IVDs and clinical trials. She liaises with SALDA members and other stakeholders across the medical technology industry, with a particular emphasis on IVDs. She takes a solutions-driven approach to assisting the industry in navigating regulatory requirements, product importation, tenders, validation and health technology assessment.

Sarah represents SALDA on the SAHPRA Regulatory Technical Forum. She is also a member of the Medical Devices Professionals Group and the South African Clinical Trials Association, and serves as an ASLM Ambassador.

She is passionate about training, lecturing and mentoring clinical trial and laboratory personnel, as well as upskilling the next generation of pharmaceutical sciences students for the medical technology industry.

Sarah holds a bachelor’s degree in Laboratory Management from Pretoria, a master’s degree in Operations Management from Johannesburg and an MBA from Australia.

Kim Stephenson is a Clinical and Regulatory Affairs professional with over 10 years of experience spanning clinical research, medical devices, digital health and regulatory affairs. She currently serves as Clinical and Regulatory Affairs Lead at AI Diagnostics, a South African medical technology company developing accessible, AI-enabled diagnostic solutions.

At AI Diagnostics, Kim supports the clinical and regulatory development of Ostium™, a digital stethoscope platform, and AID.TB™, an AI-enabled solution designed to support decentralised tuberculosis screening. Her work includes developing regulatory strategies and preparing technical documentation to support medical device submissions across multiple markets. This involves translating regulatory requirements into product development and evidence-generation activities, supporting clinical evaluation and human factors programmes, and coordinating submission documentation for emerging and AI-enabled medical technologies. Her work considers both national regulatory requirements and broader global access pathways, including WHO and international procurement frameworks relevant to diagnostics in high-burden settings.

Kim has a particular interest in regulatory pathways for emerging medical technologies, AI-enabled medical devices and decentralised diagnostics, and how regulatory reliance and global access mechanisms can support earlier and more equitable access to healthcare innovation.

Dr. Prafulla K. Chitnis, with over 30 years’ experience in the QC Micro space, has spearheaded Charles River India operations since its inception in 2008 and now supports Business Development in the Middle East, India, and Bangladesh. He holds a PhD in molecular biology from the National Chemical Laboratory, Pune, India. As a member of the Rockefeller Rice Biotechnology Foundation, he was actively involved in bringing Plant Molecular Genetics technology to India in the late 1980s. He is privileged to have been trained by Dr James Cooper in the Bacterial Endotoxins Test at the Medical University of South Carolina, Charleston, USA. Later, in 1996, he worked closely with the Indian Pharmacopoeia to introduce the Bacterial Endotoxins Test in India. He also represented India in the “Joint International Validation of the Endotoxin Standard”. His long association with the Indian Pharmacopoeia continues to date, and he continues to contribute to the Indian Pharmacopoeia as a member of the Expert Working Group. He has conducted many workshops and training programmes across India, including some in collaboration with the PDA India Chapter, for the pharma industry on risk management in microbiology, with a focus on endotoxin testing, biological indicators, and microbial identification.

Mai Ahmed Faied, is a senior vigilance and product safety professional with more than 14 years of experience spanning pharmaceuticals, biologics, and medical devices within both regulatory authority and industry environments. Her career has been dedicated to advancing patient safety through pharmacovigilance, materiovigilance, risk management, and post-market surveillance activities.

Currently serving as Local Safety Responsible (LSR) at Medtronic, Mai acts as the primary local liaison for medical device vigilance matters, serving as the key interface between health authorities, global manufacturers, and internal stakeholders. She supports vigilance activities across African markets, throughout the product lifecycle, from regulatory approval through post-market oversight, including vigilance reporting, implementation of Field Safety Corrective Actions (FSCAs), and ensuring compliance with local vigilance requirements.

Prior to joining Medtronic, Mai served as Qualified Person for Pharmacovigilance (QPPV), where she established and maintained compliant pharmacovigilance and medical device vigilance systems and supported regulatory interactions related to product safety and post-market surveillance. Earlier in her career, she spent nearly six years at the Egyptian Pharmaceutical Vigilance Center (EPVC) within the Egyptian Drug Authority (EDA), contributing to regulatory decision-making through the evaluation of safety data, benefit-risk profiles, risk management plans, and safety-related regulatory submissions.
Drawing on experience from both regulatory authority and industry environments, Mai brings a unique perspective on the product safety lifecycle, bridging regulatory expectations with practical implementation to support compliance and patient protection.

Mai holds a Master’s degree in clinical pharmacy (Pharmacovigilance) and a Bachelor of Pharmaceutical Sciences from Ain Shams University.

Dr. Karim Wahba is the Head of Regulatory Affairs and Trade Compliance for Middle East & Africa at Merck life science. With over 15 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.

Mr. Yussuf Osman Ahmed is the Director of Enforcement at the Anti-Counterfeit Authority (ACA), the lead government agency mandated to combat counterfeiting, trade, and other dealings in counterfeit goods in Kenya. The Authority operates under the Ministry of Trade, Investment and Industry, State Department for Industry. In his capacity as Director, Mr. Osman provides strategic leadership and policy direction in enforcement operations, ensuring compliance with the Anti-Counterfeit Act, No. 13 of 2008, and coordinating multi-agency efforts aimed at curbing illicit trade and protecting consumers and legitimate businesses.

With an extensive career spanning over twenty-five (25) years in consumer protection and intellectual property rights (IPR) enforcement, Mr. Osman brings a wealth of experience and institutional knowledge in law enforcement and regulatory compliance. He began his public service career in the year 2000 as an Investigating Officer and Prosecutor with the Weights and Measures Department, then under the Ministry of Trade and Industry, where he was instrumental in enforcing fair trade practices and consumer protection laws.

In 2010, Mr. Osman joined the Anti-Counterfeit Authority as an Anti-Counterfeit Inspector II, marking the beginning of his long and progressive service within the institution. Through diligence, integrity, and exemplary leadership, he rose through the ranks to become Regional Manager, Eldoret in 2016, and subsequently Regional Manager, Mombasa in 2018, overseeing enforcement operations in the entire Coast Region, including strategic points such as the Port of Mombasa and the Lunga Lunga Border Post. In these roles, he provided regional supervision of inspectors, coordinated enforcement operations in collaboration with the Kenya Revenue Authority (KRA), Kenya Bureau of Standards (KEBS), Directorate of Criminal Investigations (DCI), and other partners under the Multi-Agency Framework Against Illicit Trade (MAFAT).

Mr. Osman’s leadership has been pivotal in developing operational strategies that strengthen border control, enhance compliance with intellectual property laws, and safeguard the Kenyan market from counterfeit and substandard goods. His commitment to capacity building has also seen him mentor numerous enforcement officers and contribute to national policy development on IPR protection.

Academically, Mr. Osman holds a Bachelor of Education (Science) degree in Mathematics and Chemistry from Kenyatta University and a Master’s Degree in Intellectual Property from Ankara University, Turkey and currently pursuing Masters of Science in Governance, peace and security at Africa Nazarene university. He also holds a Diploma in Intellectual Property from Mount Kenya University and advanced professional certifications in Trademarks, Industrial Designs, Geographical Indications, Copyright, and Related Rights from the World Intellectual Property Organization (WIPO). Additionally, he has successfully completed the Strategic Leadership Development Program (SLDP) and Senior Management Course at the Kenya School of Government (KSG), alongside numerous other professional and management courses focused on leadership, governance, and enforcement strategy.

Mr. Osman is a dedicated public servant, visionary leader, and strong advocate for consumer rights and fair trade. His exemplary service and contributions to the enforcement of intellectual property laws continue to play a crucial role in strengthening Kenya’s fight against counterfeiting and promoting a secure and competitive market environment. Osman is the Director Enforcement of the Anti-Counterfeit Authority (ACA), the lead Kenya Government Authority mandated to Combat Counterfeiting, trade and other dealings in counterfeit goods. The Authority is under the Ministry of Trade, Investment and Industry- state Department of industry.

Catherine Mwendwa is a pharmaceutical regulatory affairs leader with over 10 years of experience in Regulatory Affairs and Pharmacovigilance across African markets. She holds a Bachelor of Pharmacy and an MBA, combining technical pharmaceutical expertise with strategic business leadership.

Catherine currently serves as Head of Regulatory Affairs, where she leads regional regulatory strategy and capability development across Africa. Her areas of expertise include market access, regulatory intelligence, regulatory harmonization, reliance pathways, pharmacovigilance, pharmaceutical traceability and regulatory compliance.

She is passionate about positioning Regulatory Affairs as a strategic enabler of sustainable business growth, integrating regulatory considerations early to manage compliance risk while supporting innovation, market access and business continuity.

Mr. Chacha Sammy Nyanswi is a highly experienced Integrated Regulatory Information Management System (IRIMS) Consultant, Project Manager and Implementation Team Lead at SoftClans Technologies Limited. With more than 12 years of experience in digital transformation, regulatory technology and software project delivery, he has led and supported IRIMS implementations across several African markets, including Tanzania, Zambia, Rwanda, Botswana, Nigeria, Namibia, Uganda, Ghana and Burkina Faso, as well as the ZAZIBONA collaborative initiative.

His expertise covers the complete system implementation lifecycle, including regulatory business process analysis, requirements definition, solution design, workflow automation, system configuration, data migration, interoperability, validation, stakeholder engagement, capacity building, deployment and post-implementation support. His work spans product registration, inspections, laboratory management, pharmacovigilance, clinical trials, import and export control, finance, electronic document management and regulatory reporting.

Chacha holds a bachelor’s degree in computer science, a Project Management Professional qualification, and a Professional Masters in Capacity Building in Astronautics from Sapienza University of Rome. He is also pursuing a Master of Science in Information Technology Management at the University of Nairobi. He is passionate about using secure, scalable and sustainable digital technologies to strengthen regulatory systems across Africa.

A 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 Associate Director Regulatory Affairs for MEA & CEESAT region for Electrophysiology/neurovascular business at JNJ Medtech, 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.

Wilfrid is a Pharmaceutical Traceability & Compliance Specialist at VISIOTT, working in the marketing department to advance traceability solutions for pharmaceuticals and medical devices. With a background in Biomedical Sciences, he brings an understanding of public health and regulatory compliance, supporting safer and more traceable healthcare supply chains in international markets.

Dr. Mirette is a highly skilled regulatory affairs professional with 18 years of experience specializing in medical device regulatory affairs. Throughout her career, Mirette has been at the forefront of regulatory changes and has successfully navigated the evolving landscape of medical device regulations. Her extensive knowledge of regional regulatory requirements enables her to provide strategic guidance and support to organizations seeking to bring safe and effective medical devices to market.

Dr. Mirette’s expertise spans a wide range of regulatory processes, including product classification, registration submissions, quality management systems, and post-market surveillance.

She actively engages with regulatory authorities, industry associations, and other stakeholders to shape and promote best practices that prioritize patient safety and product quality as well to ensure compliance to the regulation in place. Her dedication to ongoing education and staying up to date with the latest regulatory developments allows her to effectively advocate for industry advancements while maintaining compliance.

As a leader in her field, Mirette is known for her collaborative approach and ability to work seamlessly with cross-functional teams. She understands the importance of clear communication and building strong relationships with regulatory authorities, fostering an environment of trust and cooperation.

With her 18 years of experience in medical device regulatory affairs, Mirette brings a wealth of knowledge and expertise to any organization. Her commitment to advocacy, shaping regulations, and ensuring compliance and product safety makes her a valuable partner in navigating the regulatory landscape and driving successful regulatory strategies.

Mr. Prem Kumar S is the Senior Director and India Head at LSPedia, leading global implementation delivery and India operations.

He brings extensive expertise in pharmaceutical traceability, serialization, and regulatory compliance, with experience spanning DSCSA, EU FMD, EPCIS, system integrations, master data, and regional compliance requirements across Africa, the GCC, Asia Pacific, CIS, and the Americas.

Prem is also leading the development of LSPedia’s India Center of Excellence, strengthening delivery capabilities, scalable operations, and cross-functional support for global growth.

Ms. Mary Kinyanjui is a regulatory affairs professional with over a decade of experience supporting regulatory strategy, market access, and compliance for medical devices and in vitro diagnostics across Africa. She currently serves as Senior Specialist, Commercial Regulatory Affairs at Cepheid, where she leads regulatory activities across East, West, and North Africa, working closely with regulatory authorities, industry stakeholders, and healthcare partners to facilitate access to innovative diagnostic technologies.

Throughout her career, Mary has developed extensive experience navigating diverse regulatory environments and advancing regulatory convergence, reliance, and harmonization initiatives across the continent. Her work focuses on enabling timely patient access to safe, effective, and high-quality medical technologies while supporting regulatory systems that are proportionate, science-based, and sustainable.

Mary has also played an active leadership role within the industry, serving as Vice Chair of the Medical Devices Association of Kenya (MEDAK) from 2023 to 2024. In this capacity, she contributed to industry-regulator engagement, policy discussions, and advocacy efforts aimed at strengthening the medical technology ecosystem in Kenya and the broader East African region.

Beyond her professional responsibilities, Mary is a passionate advocate for human sustainability and wellbeing. She believes that lasting impact is achieved when people remain at the center of the systems, policies, and decisions that shape healthcare. She actively promotes awareness of the human dimension behind the work of regulatory affairs, healthcare delivery, and organizational leadership.

Outside of work, Mary prioritizes movement and wellbeing as important components of a balanced life. She enjoys dancing, walking, and stretching, practices that help her maintain energy, perspective, and resilience while navigating the dynamic healthcare and regulatory landscape.

Dr. John Juma is a Pharmacist and Regulatory Affairs Specialist with expertise in medical devices and in vitro diagnostics (IVDs) across African Markets. He is currently responsible for the East Africa regulatory portfolio at Becton Dickinson (BD), overseeing a wide range of medical devices and IVDs across Kenya, Tanzania, Uganda, Ethiopia, and Rwanda. His responsibilities include regulatory strategy, product registrations, lifecycle management, Health Authority engagement, regulatory intelligence, and industry advocacy. He also serves as Committee Lead of the Education and Training Committee of MEDAK, Kenya’s medical device and IVD industry association.

Dr. Juma is a RAPS Certified Medical Devices Regulatory Professional and holds a Bachelor of Pharmacy from the University of Nairobi. He has a particular interest in regulatory convergence, reliance, and practical collaboration between regulators and industry as mechanisms to enhance regulatory efficiency and improve timely access to safe, effective, and quality health products and technologies.

Johnpaul Omollo is a seasoned public health professional and policy strategist with over a decade of experience advancing health systems transformation, R&D regulatory frameworks, and health technology access across Africa. Currently serving as the Policy and Government Affairs Partner for Africa at Roche, he leads continent-wide advocacy to strengthen diagnostic systems and build resilient health ecosystems in line with Roche’s regional strategy. Holding a Master’s degree in Public Health, Johnpaul leverages deep expertise in health policy, clinical trial governance, regulatory harmonization, and government engagement to effectively bridge policy and practice for meaningful health impact.

Dr. Lucas Nyabero is a distinguished healthcare executive and pharmacist with over 12 years of proven success in the pharmaceutical and healthcare sectors. He earned his Doctor of Pharmacy (Pharm.D.) from MCPHS University in Massachusetts and has held pivotal leadership roles, including serving as CEO of the Pharmaceutical Society of Kenya, where he championed policy reform and advanced pharmacy modernization.

As the Superintendent Pharmacist at Xenopia Group, Dr. Nyabero applies his extensive expertise in regulatory compliance, operational leadership, and complex healthcare system management to uphold the highest standards of safety, quality, and efficiency. His strategic oversight ensures that pharmaceutical governance aligns seamlessly with international best practices while optimizing supply chain and operational performance.

Beyond his corporate leadership, Dr. Nyabero is a driving force in oncology and global health initiatives. He serves on the Executive Committee of the City Cancer Challenge, contributing to the development of robust cancer care infrastructure. With specialized certification in Pharmacogenomics and experience managing significant Global Fund grants, he demonstrates a steadfast commitment to precision medicine and sustainable healthcare solutions, making him an invaluable leader and visionary within the Xenopia Group team.

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.

Olivia ESISO NGOMOSI is a leading authority in corporate law, regulatory engineering, and digital compliance across Central Africa. As an Attorney at Law and Senior Legal Expert, she brings extensive experience in guiding multinational corporations, vital national infrastructures, and cross-border investors through complex regional legislative transformations and high-stakes regulatory environments.

As the Founder and Chief Executive Officer of LIVY SARLU, based in Kinshasa, Democratic Republic of the Congo, she has pioneered a groundbreaking approach to corporate governance. Her practice seamlessly bridges OHADA business law with advanced technical cyber-resilience frameworks, helping healthcare, pharmaceutical, mining, and fintech enterprises navigate local penal liabilities and data sovereignty imperatives. She is the author of “The Methodological Manual for Digitalized Sector Compliance Engineering in the DRC,” a landmark scientific and operational auditing framework fully protected by State Patent No. 0017011.

Renowned for her strategic leadership, Me ESISO advises executive boards on aligning international investments with national regulatory frameworks, including the DRC Digital Code and the African Union Malabo Convention. Her work focuses on transforming regulatory compliance from a reactive legal burden into a proactive shield for cross-border capital, supply chain integrity, and critical medical infrastructure. In close collaboration with national authorities and international partners, she continues to shape the future of tech-legal compliance engineering in sub-Saharan Africa.