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

Mr. Abebe Alamneh, esteemed regulatory affairs professional at East Africa Regulatory Affairs professionals Association (EARAPA) and Ethiopia Food and Drug authority (EFDA) , is a distinguished leader in the field of pharmaceutical regulatory affairs. With over 4 years of experience in leadership in the professional association and more than 8 years in the pharmaceutical regulation , he has been instrumental in pioneering the establishment of the East Africa regulatory affairs professionals association, an important plat form for regulatory information sharing, capacity building and cooperation’s among the East African and African pharmaceuticals regulatory system. Mr. Abebe holds Msc. in pharmaceutical regulatory Affairs from Addis Ababa University and Bpharma from Mekelle University.

A passionate advocate for the advancement of pharmaceutical regulation in Africa , Mr. Abebe regularly speaks at international conferences, sharing his insights on the future of regulatory landscape in East Africa region and the continent at large.

Dr. Mona Al Moussli is a trailblazer in the field of pharmaceutical and medical device regulatory affairs in the Middle East. With over twenty years of experience, she has firmly established herself as a seasoned professional renowned for her unparalleled expertise in navigating the intricacies of healthcare regulations.

Throughout her career, Dr. Al Moussli has demonstrated an unwavering dedication to upholding the highest standards of ethics and compliance within the industry. In 2013, she co-founded PRA Consultancy, a firm that has since become synonymous with regulatory excellence in the region.

Her impact transcends traditional boardroom boundaries as she actively works to shape the future of healthcare regulation through education and advocacy. Notably, Dr. Al Moussli played a pivotal role in the inception of the GCC Regulatory Affairs (RA) Course, a pioneering certification program designed to nurture the next generation of industry experts.

Fueled by her passion for advancing health and safety standards, Dr. Al Moussli has spearheaded numerous initiatives, including the renowned GCC Regulatory Affairs Pharma Summit and other significant gatherings focused on pharmaceutical-related regulations in the region.

Dr. Al Moussli’s commitment to advancing regulatory standards transcends borders, as evidenced by her initiation of the AFRI Summit. This crucial platform facilitates discussions on pharmaceutical and medical device regulations in Africa, fostering knowledge sharing and collaboration among stakeholders to improve healthcare outcomes across the continent.

Beyond her professional achievements, Dr. Al Moussli remains actively involved in community engagement, serving as an advisory board member at Dubai Pharmacy College and lending her expertise to the Women’s Business Council at the Dubai Chamber of Commerce. In recognition of her outstanding contributions, Dr. Mona Al Moussli was elected as a board member of the Emirates Medical Association – Pharmacy chapter for consecutive terms in 2021 and 2022.

Loshnee Vandayar has worked in Regulatory Affairs across Africa for more than 12 years. She has a BSc in Biochemistry and Microbiology from the University of KwaZulu Natal, a National Diploma in Biomedical Technology from the Cape Peninsula University of Technology as well as a Post Graduate degree in Business Management. Loshnee is currently busy with an MBA in Healthcare Management. She has extensive, hands-on laboratory experience and has worked in the Medical Device and IVD industry for over 15 years with managerial positions in both Quality Assurance, Compliance and Regulatory Affairs. She has been with Cepheid since 2019 and currently holds the role of Senior Manager, International Regulatory Affairs for Eastern Europe, Middle East and Africa.

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.

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.

Rana is an experienced Regulatory Affairs Professional with a demonstrated history of working in leading multinational medical devices companies such as Medtronic, Johnson & Johnson and Hospira Pfizer. During her career, Rana has managed to take over regulatory roles of increased responsibilities with an extended area coverage where she has built extensive knowledge of the regulations across MEA region.

Rana holds a Medical Laboratory Sciences degree along with a Regulatory Affairs Certification (RAC) from RAPS, and a certificate in “Regulation: Theory, Strategy & Practice” from London School of Economics & Political Sciences (LSE).

In her current role as Regulatory Affairs Director at Mecomed, Rana is responsible for managing

Regulatory Affairs-related responsibilities in MECOMED, the Medical Technology Association in Middle East and Africa, and works closely with the different MedTech stakeholders such as Ministry of Health officials and Regulatory agencies to advance the Medical Technology Regulations in the region.

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.

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

Dr. Asmaa Awad is a dedicated professional with a strong commitment to advancing the field of regulatory science and driving positive change in the healthcare ecosystem. Her work is centred on ensuring patients have access to safe and innovative healthcare products.

She holds a Bachelor of Pharmacy from Mansoura University and currently collaborates with a diverse range of external stakeholders, including the World Health Organization (WHO), the International Medical Device Forum (IMDRF), the Global Harmonization Working Party (GHWP), the Medical Device Regulatory Capacity Building (MDRC) project team, Mecomed, and national regulatory authorities.

Through these partnerships, Dr. Awad plays a pivotal role in driving the convergence, reliance, and adoption of international best practices to accelerate patient access to cutting-edge healthcare products. Her efforts are aimed at improving patient health outcomes and alleviating the burden on healthcare systems.

Dr. Awad’s specialized expertise lies in medical devices and in vitro diagnostics (IVDs), where she actively contributes to the development and influence of regulatory policies and frameworks. Her work enhances product accessibility and ensures patient safety, making a significant impact on health outcomes across various regions.

Prior to her current role, Dr. Awad served as the Regional Regulatory Affairs Manager for the Middle East and Africa. In this position, she led major projects, including MDR/IVDR and Brexit, ensuring compliance with regulatory requirements and providing strategic guidance to cross-functional teams to bring innovative products to market.

Dr. Fazila is a Regulatory Affairs  over 15 years of diversified experience from various leadership positions in Regulatory Affairs , Quality Assurance Pharmacovigilance outsourcing  Project Management  within multinational organizations at both regional and local levels.

Dr. Fazila  is currently leading  French Africa speaking cluster Regulatory Affairs,. In her role in Abbott Established Pharmaceutical Division; Fazila is responsible for setting Regulatory Strategies for New Product Introduction, Geo-expansion, Licensing & Acquisition, Localization, Life cycle management, enhancement of promotional model, as well as Regulatory risk mitigation and regulatory compliance.

Dr. Fazila has set effective regulatory strategies of external engagement including Health authorities, local distributors, trade associations and Third-Party Manufacturers.

Dr. Fazila is holding a bachelor of pharmaceutical sciences from Algeria University and has a lot certifications   in project management leadership for results and Market Access

Dalia Safwat is seasoned Quality assurance professional with Over 20 years in pharmaceutical industry. Dalia is dedicated to ensuring the highest standards of safety and quality in pharmaceutical practices.

Core Qualifications:

• Strong Knowledge in Pharmaceutical industry.
• Strong Knowledge in Distributor quality management
• Strong Knowledge in Pharmacovigilance activities

I am Currently serving as Quality assurance manager for Africa and ME at Alcon.

With bachelor’s degree in pharmacy from Helwan University and an MBA from The Arab Academy for Science, Technology & Maritime Transport.

He is the Manager International Affairs at MedTech Europe the European trade association for the medical technology industry including diagnostics, medical devices and digital health. In this position, Dario manages and coordinates projects and working groups addressing market access, trade policy initiatives and international regulatory matters in the medical technologies sector, with a primary focus on the countries outside of Europe. He holds a master’s degree in international economics from the University of Antwerp (Belgium).

Christopher serves as the Pan-Africa Regulatory Policy and Intelligence Partner at Roche Diagnostics, in Africa.

Christopher also serves and leads various industry associations representing both local and multi-national companies. In Kenya, he is the Executive-Secretary of MEDAK (Medical Technology Industry Association of Kenya) as well as the Honorary Treasurer at KAPI (Kenya Association of Pharmaceutical Industry). Christopher is also a member of the Africa Working Group in several Regional and Global industry associations, including Mecomed, MedTech Europe and GMTA.

Focal Point of the WHO-AIRP Collaborative Procedure for the Evaluation of In Vitro Diagnostic Medical Devices (IVDMs) for WHO Prequalification

“Frank N Laban is a Pharmacist at the Zambia Medicines Regulatory Authority with 16 years of experience as a regulator in the area of medicines and medical devices regulation.

Mr. Laban is responsible for supervising marketing authorization and related activities on Medical Devices and Human Medicines and is the country focal person for the WHO PQ Collaborative Registration Procedure for In Vitro Diagnostics.

Mr. Laban has extensive experience in medical device regulation and regulatory harmonization initiatives for medical devices.  During his career, he has participated in various continental activities around medical product regulatory convergence initiatives.

Frank holds a holder of a BPharm and is a candidate for MSc Pharmacy Administration and Policy

Dr. Ivan Emil is a Microbiologist and a seasoned Public Health Laboratory Scientist with over a decade of experience as the Division Manager at Rwanda’s National Reference Laboratory. His management led to the laboratory attainment of ISO 15189. His extensive background encompasses regulatory affairs at national, regional, and international levels, with a strong emphasis on infectious diseases through research and academia work skillset.

In his current role at the Rwanda Food and Drugs Authority (Rwanda FDA), he serves as a Technical Analyst, responsible for the assessment of medical devices, in vitro diagnostics (IVDs), vaccines, and biologicals. At Rwanda FDA, He has played a key role in implementing regulatory reliance and recognition pathways, streamlining registration processes for medical devices and IVDs to facilitate efficient market access. His involvement in the Rwanda FDA Quality Management Committees further underscores his commitment to advancing regulatory standards and improving practices through collaborative pathways.

Dr Ivan’s contributions are essential to the ongoing development of medical device regional harmonization regulations, ensuring registration of quality product on Rwandan Market that are safe and efficacious to fit Rwanda FDA long term mandate of protecting public health

Ms Khanyisile Nkuku In her current role she contributes her expertise in the assessment and registration of medical devices & IVD’s in South Africa in an effort to promote medical device & IVD access on a global scale, with a particular focus on African countries.

She holds a Bachelor of Pharmacy  honours degree from the University of Witwatersrand, Master’s in Pharmacy administration & Policy Regulations from University of Western Cape and is currently busy with Masters in Business Administration in Healthcare Leadership at University of Witwatersrand.

She is an experienced Pharmacist with successful background in medical device & IVD regulations and regulatory system strengthening.  Having great strength in policy advocacy, policy development, policy implementation and compliance. She has experience and knowledge in medical device & IVD registration, clinical trials regulation, law enforcement, post marketing surveillance, and good reliance plus regulatory practice.

She partakes in the International medical device regulatory forum (IMDRF) working groups and Africa medical device forum (AMDF) working groups. She is further a committee member for two SABS Technical committees as well as HPSCA task team .

Khatija Suleman is a pharmacist with a postgraduate qualification in clinical pharmacology. She has 35 years of dynamic engagement in pharmaceuticals, medical devices, in-vitro diagnostics, clinical pharmacy and academia. Her experience and expertise in various sectors of the healthcare industry emanates from a wide range of roles and responsibilities in medical affairs, regulatory affairs, clinical trials, pharmacovigilance, post marketing surveillance, quality management, education and training. Leveraging her extensive background, she actively contributes to enhancing and shaping regulatory frameworks to decrease complexity, while supporting advancement of healthcare delivery and patient safety

A pharmacist, holding a master’s degree in business administration with a focus on Health Economics from Arab Academy for Science, Technology and Maritime Transport with Regulatory affairs experience more than 9 years.

She earned Regulatory Affairs Certificate in Medical devices from RAPS Online University since 2021 and ISO 13485:2016 Auditor/Lead Auditor from BSI since 2021.

Marvin Turinaiwe is a pharmacist and Regulatory Officer at the National Drug Authority in Uganda, with three years of experience in the pharmaceutical sector. He specializes in the assessment and registration of drugs, medical devices, and healthcare products, ensuring compliance with regulatory standards.

Marvin also has experience as an Analyst in the Quality Control Laboratory, where he contributed to quality management and analytical testing. Additionally, he has worked as a Supervising Pharmacist in community pharmacy, enhancing his understanding of healthcare delivery.

Marvin is passionate about fostering collaborations that improve regulatory processes and access to essential medications on the worldwide.

She holds a bachelor’s degree of pharmaceutical sciences from an established Egyptian university and a master’s degree in business administration from Arab Academy for Science, Technology & Maritime Transport, (AASTMT), where she specialized in supply chain.

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

From November 2020, Miriam became the head of Central Administration of Medical Devices.

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

The most significant achievements that took place under her leadership:

• Egypt, represented by Egyptian Drug Authority, became an affiliate member of International Medical Devices Regulatory Forum (IMDRF) on October 2023.
• Egypt, represented by Egyptian Drug Authority, became a permanent member of Global Harmonization Working Party (GHWP) in December 2023.
• Egyptian Drug Authority joined African Medical Devices Forum (AMDF) in February 2024.
• Enhancing the localization of many medical devices and equipment.
• Establishing an online platform (MeDevice) for automating administrative
• workand electronic archiving.
• Issuing guidelines to regulate all procedures related to premarket approvals, unique device identification and labelling requirements.
• Developing a procedure to regulate the import and circulation of laboratory and diagnostic reagents for the first time in the Arab Republic of Egypt.
• Unique device identification(UDI) was applied to all medical devices that are circulated in the local market in October 2022

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

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

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

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

Mr. 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.

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

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

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

In 2005, the consultancy business started providing.

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

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

Dr. Noha El-Hariri is the General director of the general administration of medical devises registration -Egyptian drug authority (EDA) since 2020 and until now. She is also the supervisor of investment support & localization of medical devices, medical equipment & iVDs at EDA.

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

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

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

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

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

Dr. Rachel J Mujawimana is a pharmacist with 14 years of experience in the pharmaceutical sector, covering community and regulatory pharmacy. She currently works as an Inspector of Drugs at the Uganda National Drug Authority, where she is responsible for ensuring the quality and safety of medicines and medical products in Uganda.

Dr. Rachel is the focal person for medical devices within the Directorate of Inspectorate and Enforcement. She holds a Master’s degree in Pharmaceutical Sciences from Trinity College Dublin and is certified in ISO 13485, specializing in quality management systems for medical devices.

In her role, Dr. Rachel has been actively involved in screening imports of drugs and medical devices to ensure compliance with regulatory standards. She has also contributed to policy discussions on Uganda’s new legislation regarding medical devices and carried out audits of manufacturers, improving regulatory compliance and raising safety standards. Dr. Rachel is dedicated to advancing public health and ensuring that safe, high-quality medical products are accessible to all.

Dr. Rafik Khazri, pharmacist, charged of the Medical Devices Regulatory Affairs, leads the development of regulatory texts and the digital transformation initiatives at the National Agency of Medicines and Health Products in Tunisia. He oversees key projects, including the implementation of digital tools for regulatory processes. Dr. Khazri is a key player in advancing the medical device regulatory framework and is also actively involved in strategic efforts to modernize and streamline the medical device regulations in Tunisia, contributing to the national vision for improved healthcare governance.

Ms Sarah Cohen, currently the Executive Officer at SALDA and an independent consultant, brings a wealth of expertise cultivated over a four-decade career in the medical and research industry. She obtained her Bachelors degree in Laboratory Management (Pretoria), Masters in Operations Management (Johannesburg) and MBA (Australia).

Her contributions encompass training, coaching, and mentoring thus upskilling the next generation for the MedTech industry. Sarah is a certified auditor, reflecting her commitment to maintaining high standards in the industry.

In her role as SALDA Executive Officer, Sarah has been instrumental in driving SALDA initiatives and fostering engagement with key industry stakeholders underscoring unwavering commitment to collaborative efforts within the industry

A passionate advocate for innovation in medical technology, Ms Cohen regularly speaks at conferences, and events sharing her insights on the future of IVDs (in vitro diagnostics) and their impact on medical technology.

Shellan Omondi is a regulatory officer at the Pharmacy and Poisons Board (PPB) in Kenya, where he is part of the Department of Product Evaluation and Registration in the Medical Devices and In Vitro Diagnostics (IVD) Unit. He oversees the evaluation and registration of medical devices and IVDs to ensure they meet safety, efficacy, and quality standards in the Kenyan healthcare market.

Mr. Thabo B. Bokhutlo is a Medical Laboratory Scientist by profession. For the last 3.5 years, he has been involved in the medical devices dossier assessments in the Department of Product Evaluation and Registration, at the Botswana Medicines Regulatory Authority (BoMRA) in Gaborone, 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 In-vitro Diagnostics (IVDs).