Speakers : Workshop on Regulatory Convergence for Healthcare Products in West Africa

Kirti Narsai
Senior Africa Health Specialist
Corporate Council on Africa

Moderator

Kirti Narsai has over 26 years’ experience in the healthcare industry with experience across pharmaceuticals, medical devices and consumer products. She has held board positions in several large organisations with Pan African interests and has participated in several strategic initiatives in Africa, including the African Regional Business Network (WEF Africa), Health/Medical Devices Master Plan in South Africa, Market Design & Demand Intelligence workstream of the Partnership for African Vaccine Manufacturing (PAVM) and regulatory harmonisation in the SADC region. She currently runs her own consultancy, HealthValue Consulting (Pty) Ltd, which focuses on providing advisory services to the healthcare sector evolving health and trade policy issues in Africa. She also holds a part time position as Principal Researcher at the Nelson Mandela School of Public Governance leading research on establishment and growth of regional healthcare value chains through focus on local manufacturing capabilities under the AfCFTA. She is currently completing her PhD in Pharmaceutical Policy at the Utrecht University, Netherlands. She has published several research articles and OpEds and is a regular speaker at conferences and webinars on topics related to health policy and trade. During her spare time, she volunteers as a mentor for the African Academy of Sciences (AAS) and the Pan African Women in Health (PAWH).

Prof. Moji Adeyeye

Director General

National Agency for Food and Drug Administration and Control (NAFDAC)

Prof Moji Adeyeye is the Director General of National Agency for Food and Drug Administration and Control (NAFDAC) where she has added strong governance structure and regulatory strengthening to NAFDAC through disciplined and motivating workforce, updating of regulations and guidelines, strengthening the local pharmaceutical companies through international best practices, and encouraging local production. She has brought NAFDAC from insolvency to solvency. She refocused the Agency through Quality Management System approach and WHO Global Benchmarking to be Standard Operating Procedure-driven organization that has embraced international standards and best practices. This has resulted in attainment of ISO 9001-2015 in 2019, WHO Maturity Level 3 (ISO 9004) in 2022 (a recognition as a well-functioning Agency in many regulatory functions), and Prequalification of Lagos Central Drug Control Laboratory in 2023. She changed the culture of NAFDAC to Customer-focused and Agency-minded establishment in order to safeguard the health of the nation. The Director General is keenly involved in the Lot Release, Post-Approval Safety Monitoring, and Traceability of COVID-19 vaccines, that is focused on visibility of COVID-19 Vaccines Supply Chain using GS1-driven Technology nationally and continentally. She has initiated research collaboration with several institutions as a means of increasing staff competency and improving regulatory research.

Dr. Simon Agwale

CEO

Innovative Biotech Nigeria

Simon Agwale, Ph. D is the CEO of Innovative Biotech, Nigeria and Innovative Biotech USA Inc. Dr Agwale is the Vice Chair of AVMI’s Board of Directors and the lead of the Vaccine Technology working group. He was the lead and member of the Africa CDCPAVM’s Technology Transfer and IP bold program and Talent Development workstreams respectively. Dr. Agwale has a vision for the development and investigation of HIV vaccine constructs from prevalent Nigerian strains which are relevant to Nigerians. He is also currently developing novel vaccines against Covid-19, Ebola, HPV, and HIV using innovative viral-like particles (VLPs), and has recently licensed several technologies, which he is in the process of further developing and commercializing. Through INNOVATIVE, Dr. Agwale is striving to further develop and refine these dynamic, novel treatments, and in doing so, expand domestic vaccine manufacturing capabilities in Nigeria to serve the African community. Dr. Agwale was a Postdoc fellow at the Institute of Human Virology Baltimore, USA and Visiting Scientist at various institutions in Brazil, Germany, UK including the US Vaccine Research Center/NIH, and US Center for Disease Control and prevention in Atlanta. Dr. Agwale was West Africa's representative on HIV/AIDS for Developing countries Coordinating Committee (DCCC) at European and Developing Countries Clinical Trials Programme, where he was also the chair of the African Scientists committee (DCCC). He is a recipient of several scholarships, fellowships and grants from reputable organizations around the world. He has also authored and co-authored numerous noteworthy publications.

Dr. Kwasi Boateng

Director

U.S. Pharmacopeia (USP)

Kwasi Poku Boateng graduated from the then University of Science & Technology (UST) with a BPharm (Hon’s) degree in 1992. He is a Fellow of the Pharmaceutical Society of Ghana and the Ghana College of Pharmacists. He has an MBA in Strategic & Project Management from the Paris School of Management. He has certifications from the American Society for Quality (ASQ) as a Certified Pharmaceutical GMP Professional and Certified Quality Auditor.

For the thirty (30) years he has worked as a Quality Practitioner, in the Public Sector in Ghana, Manufacturing Industry and as a Quality Management Consultant.

He is currently the Director of USP Ghana & the Promoting the Quality of Medicines plus Program (PQM+) West Africa.

Through the USP Ghana program he has led his team over the past eleven (11) years to build the capacity of over 1300 medicines regulators and pharmaceutical manufacturers from 45 countries as well as provision of direct in-country technical assistance to strengthen regulatory/laboratory systems in 10 countries in Africa. USP Ghana also works closely with the African Medicines Quality Forum (AMQF) which bring together 40 national medicines control laboratories, as a key technical partner.

Under the PQM+ program he oversees implementation of technical assistance programs in nine (9) countries in West & Central Africa to strengthen their medical product quality assurance (QA) systems. He was the PQM+ Technical lead for the development of the African Reliance Laboratory Network for Vaccine Lot Release commissioned by the African Medicines Regulatory Harmonization (AMRH) Initiative in 2022-2023.

Dr. Oumy Ndiaye

Director General

Senegalese Agency for Pharmaceutical Regulation

Doctor Oumy Kalsoum NDIAYE NDAO is a Pharmacist graduated from UCAD in Dakar, Biologist by training, specialist in supply chain management, management of projects and health programs with experience of more than 25 years in the health system. public health in Senegal.
She was pharmacist responsible for supply, Head of Technical Service and Head of Marketing/Commercial and Communication Department of the National Supply Pharmacy of Senegal.
His time of almost ten years at the NGO Intrahealth International with the Bill and Melinda Gates Foundation, is marked by the management of health projects, the most successful of which was the Push Model which later became the Yeksi-Naa which is an approach to distributing medicines and health products up to the last kilometer.
Doctor Ndao was also technical advisor to the Minister of Health and Social Action in charge of pharmaceutical policies, then Coordinator of the Support and Monitoring Unit of the National Health and Social Development Plan, Since April 2022 Doctor Ndao has been the Director General of the Pharmaceutical Regulation Agency of Senegal (ARP), in charge of the implementation of regulatory functions in the pharmaceutical sector of Senegal.

Chris LeGrand

CEO

Broadreach Group

Moderator

Chris LeGrand has more than 30 years of experience across 40+ countries, spanning private sector healthcare and life sciences industries, public health, and international health, leading organizations at the convergence of positive social impact and sustainable business results. He currently serves as CEO of BroadReach Group, a South Africa-based social enterprise that helps healthcare organizations to deliver better outcomes, improved resource efficiency, cost savings, enhanced organizational performance, and sustainable health systems. Prior to BroadReach, he served as president of DAI Global Health and before that as CEO of Futures Group. He serves on multiple boards in global healthcare, is a frequent speaker and has been awarded multiple business leadership honors. LeGrand also recently authored a book entitled ‘The Complete Business Leader: A Framework for Impact in Work and Life'. He believes in the possibility of science and technology for good, democratization of knowledge as a great equalizer, and global human-to-human connection as the path to peace.

Abisola Ayodele

Regulatory Affairs Manager

Pfizer

Abisola Ayodele is the West- African Regulatory Lead at Pfizer. She works with Global and Regional teams on regulatory strategy development to support registration and lifecycle management across 10 countries.

With 18 years of experience in varying roles within the healthcare & pharmaceutical sector, she brings diverse perspectives and a fresh approach to Regulatory Sciences.

Abisola graduated from the University of Bath, UK with a Master of Pharmacy degree, and began her career as a Clinical Pharmacist working with the NHS, UK.

Bukola Johnson

Senior Specialist, Regulatory Affairs Pharmacist for West Africa & QPPV for Nigeria

MSD

Bukola Johnson is a Pharmacy graduate from ABU, Zaria with Master degrees in Business Administration and Public Health Sciences from University of Lagos and Karolinska Institutet, Sweden respectively. He has certifications in Project Management (Prince2) and Risk Management.

Bukola is a Senior Specialist, Regulatory Affairs, with MSD Sub-Saharan Africa Regulatory team. He has gross interest in patient access to medicines and vaccines, especially in a resource-constrained economy. He is an enthusiastic believer in capacity building and regulatory system strengthening as an essential tool in delivering safe, quality and efficacious medicines to the people who have hope and trust in the Pharma Industry live-saving medicines and vaccines. Bukola states that it is really exciting to witness the growing positive changes in Africa’s regulatory landscape.

He is is married with two daughters and has great delight in reading.

Christopher Odero

Pan-Africa Regulatory Policy & Intelligence Partner

Roche Diagnostics

As Roche Diagnostics' Regulatory Policy and Intelligence Manager in Africa, Christopher Odero collaborates with stakeholders and regulators worldwide to influence and refine regulatory practices for medical devices and diagnostics across the continent. His primary mission involves facilitating the adoption of international standards and best practices through reliance and recognition mechanisms, as well as promoting regulatory harmonization and convergence. He has also gained experience working with international organizations, supporting policy and access initiatives in Africa. Mr. Odero's greatest satisfaction comes from contributing to initiatives that ensure life-saving interventions reach those who need them most, particularly in Africa.

Joseph Rieras, J.D.

J.D., Director of the Office of Trade and Global Partnerships (OTGP)

U.S. Food and Drug Administration

Mr. Joseph Rieras is the Director of FDA’s Office of Trade and Global Partnerships.  Mr. Rieras oversees FDA participation in international negotiations involving regulatory matters, including at the World Health Organization. Prior to joining FDA, Mr. Rieras served as an Associate General Counsel at the Office of the U.S. Trade Representative, in Washington, DC.  Mr. Rieras also served in Geneva, Switzerland as a Legal Advisor to the U.S. Mission to the World Trade Organization. 

Olufunke Falade

Healthcare Consultant

Nigeria Sovereign Investment Authority (NSIA)

Moderator

Funke is a healthcare financing and investment professional with over 18 years’ experience in management consulting, public health and healthcare infrastructure financing. Funke started her career with KPMG Nigeria where she provided strategy, financial and project management advisory services to clients in the infrastructure, government and health sectors. She has also worked on a series of USAID-funded health systems strengthening projects where she led resource mobilization, strategic purchasing and private sector engagement activities across six (6) states in Nigeria, Ethiopia, Mali and Democratic Republic of Congo (DRC). At the Nigerian Sovereign Investment (NSIA) where she currently works, Funke is exploring opportunities to invest in and catalyse medical manufacturing and industrialization in Nigeria. Funke holds a B. Pharm from University of Lagos, a masters in Global Health Policy and Management from Brandeis University and is a chartered, certified accountant (ACCA).

Dr. Kwesi Amissah-Arthur

Founder and Director

Quintex Pharma Inc.

Kwesi is an entrepreneur and Vitreo-retinal surgeon with practical hands-on experience in building new healthcare ventures and services in both the public and private sectors. He is currently focused on building Quintex Pharma into a manufacturer of high quality internationally certified medications in Africa for the World.

He had his medical education at the University of Birmingham Medical School and his Ophthalmology training in the UK. Together with his colleague Imoro Braimah they expanded the surgical retina service of the Korle Bu teaching hospital in Accra, where they setup the first full function public hospital vitrectomy service in West Africa.

Kwesi has co-authored two book chapters and 35 scientific peer reviewed papers. Kwesi won the Alcon UK Glaucoma prize in 2010 and the Roper Hall medal in 2008. His research grants total $675,000. This includes an H3 Africa NIH grant and a Google Deepmind grant for artificial intelligence in retinal imaging.

Kwesi co-founded GeneLab which provides high end molecular diagnostic services in Ghana and is a director of Mimosa Developers. He then moved on to found Quintex Pharma which is on track to deliver a cGMP pharmaceutical manufacturing facility in Ghana.

Abisola Ayodele

Regulatory Affairs Manager

Pfizer

With 18 years of experience in varying roles within the healthcare & pharmaceutical sector, she brings diverse perspectives and a fresh approach to Regulatory Sciences.

Abisola graduated from the University of Bath, UK with a Master of Pharmacy degree, and began her career as a Clinical Pharmacist working with the NHS, UK.

Dr. Oumy Ndiaye

Director General

Senegalese Agency for Pharmaceutical Regulation

Laird Treiber

Senior Advisor

Corporate Council on Africa

Moderator

Laird Treiber is a recognized leader and active consultant on international trade and investment issues. He was previously a career member of the Senior Foreign Service in the State Department, where he worked as an Economic Officer for more than 30 years on the full range of international economic and commercial issues, with a specific focus on identifying and resolving trade and investment barriers. Laird has extensive experience in promoting trade and investment ties with Africa, including successfully resolving AGOA related trade disputes and engaging U.S. companies on the opportunities presented by the African Continental Free Trade Agreement. He worked most recently as the State Department’s Senior Liaison for Prosper Africa, the Administration’s program to promote trade and investment between the U.S. and Africa. Laird previously served as the Economic Minister Counselor at the U.S. Embassies in South Africa, Turkey and Saudi Arabia, as well as earlier tours in Poland, Mexico and Washington. From 2018-19, the State Department detailed Laird as the Senior Adviser to the President of the Corporate Council on Africa, where he helped hold two major international events bringing U.S. and African companies together with senior government leaders.

Alex Juma Ismail

Program Officer

African Union Development Agency (AUDA NEPAD)

Mr. Alex Juma Ismail is a Programme Officer at AUDA-NEPAD, working under the Medicines Regulatory Harmonization (AMRH) initiative, specializing in regulatory systems strengthening and harmonization. He is focused on supporting the operationalization of the African Medicines Agency (AMA), particularly in the formation and strengthening of continental technical committees and continental regulatory work meant to support the foundation of a robust continental regulatory ecosystem.

Mr. Ismail has more than 9 years of experience in the medical and pharmaceutical industries. He is a pharmacist by training and has previously worked for both private pharmaceutical companies and governmental regulatory bodies In East and Southern Africa. He was also actively engaged in the regional economic communities’ medicines regulatory harmonization programmes for EAC and SADC whereas he served as the focal person assessor and regional technical officer respectively.

Sybil Nana Ama Ossei-Agyeman-Yeboah

West Africa Health Organization (WAHO)

Sybil a Ghanaian and a Pharmacist with 35 years’ experience and 25 years as Pharmaceutical and Quality Assurance Analyst. She was the former Ag. Principal Program Officer for Public Health and Pharmaceuticals as well as the Head of Public Health Division of West African Health Organization (WAHO) for the past 14 years. She was the MRH coordinator and currently on retirement but supporting the West Africa Medicines Regulatory Harmonization Initiative (WA-MRH), the Pooled Procurement Mechanism and eCTD development in the ECOWAS region. Sybil supported must of the Regulatory Agencies in the ECOWAS region to achieve Autonomy as well as strengthen their regulatory systems, quality management systems and WHO Global benchmarking maturity levels of which FDA-Ghana and NAFDAC- Nigeria have obtain ML3 while others are in ML2. She has been instrumental in the development and implementation of the Africa Medicines Regulatory Harmonization Initiative (AMRHI) and the development of the Africa Medicines Agency Treaty as well as the preparations towards its establishment. She has impacted a lot on the human resource training and capacity development of regional professionals and experts in the pharmaceutical sector, supported building of most local manufacturers capacity to comply with Good Manufacturing Practices (GMP) in the ECOWAS region. She is a PhD candidate in Public Health Administration and Policy (Walden University-USA) and Lead Auditor for (ISO 45001:2018-OHSMS, ISO14001:2015-EMS, ISO9001:2015-QMS, ISO17025:2017-QCL.

Sybil is a Regulatory Consultant and the CEO for SNAAP Access.

Kirti Narsai
Senior Africa Health Specialist
Corporate Council on Africa

Moderator

Sharika Baijnath

Regulatory Affairs Manager, Africa and EWBU, Rapid Diagnostics Division

Abbott

Sharika Baijnath is currently the Regulatory Affairs Manager for Abbott Rapid Diagnostics based in Johannesburg, South Africa. In her role, Sharika is responsible for coordinating and managing regulatory activities for the IVD and medical device portfolio in Africa.

Sharika holds a Biochemistry and Microbiology degree as well as a Masters in Agricultural science.

Her career in Regulatory Affairs began in the Agricultural industry 17 years ago. After completing her Masters, she went on to work for the Department of Agriculture. This tenure was followed by a stretch at the then Bayer Environmental Science where she was Head of Product Development and Regulatory Affairs. Her interest in health care attracted her to the industry and in 2015 she joined the world of medical devices and IVD’s, taking a Regulation Affairs Manager – Africa position at Philips. Since then she has held positions at Alcon Novartis, and Boston Scientific as the Regulatory Affairs lead for Africa.

Rana Chalhoub

Regulatory Affairs Director,

Mecomed

Rana Chalhoub is an experienced Regulatory Affairs Professional with a demonstrated history of working in leading multinational medical devices companies such as Medtronic, Johnson & Johnson and Hospira Pfizer. During her career, Rana has managed to take over regulatory roles of increased responsibilities with an extended area coverage where she has built extensive knowledge of the regulations across MEA region. Rana holds a 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 and subject matter expert in several international and regional forums in Europe, Africa, Asia Pacific and the Middle East, on several topics

Steve Kipkoti

Senior Regulatory Affairs Specialist

Medtronic

Regulatory Affairs professional in Healthcare space, with +10 years’ experience gained collectively in both Pharmaceutical and MedTech industries and a passion for networking and collaborating to tackle barriers that impact on regulatory framework systems and changing requirements towards realizing healthy patient populations in Africa. An avid lover of animals and nature, also enjoys sports and physical activity as pastime hobbies.

Enoch Nyarko

Head of Unit, In-Vitro Diagnostic Medical Devices and SaMD Medical Devices Department

Ghana Food and Drug Authority

Enoch Nyarko is a distinguished Biochemist and Principal Regulatory Officer with over 14 years of experience in regulatory oversight for medical devices and quality control of pharmaceutical products. Currently serving as the Head of the In-Vitro Diagnostic (IVD) Medical Devices and SaMD Unit at the Food and Drugs Authority (FDA) in Ghana, Mr. Nyarko leads a team responsible for the timely evaluation of IVDs to ensure quality, safety and performance as well as their compliance with regional and international standards. Mr. Nyarko holds a Master of Public Health (Epidemiology) Degree from the University of Ghana and has completed numerous professional development programmes, including Leadership and Management in Health (University of Washington), and Biotechnology and Biomedical Engineering (Indian Institute of Technology). He is an active member of several professional bodies, including the Regulatory Affairs Professional Society and has participated in numerous international regulatory convergence and harmonisation initiatives for IVDs. Aside from proficiency in English and French, Mr. Nyarko also has a strong background in laboratory analysis and profound experience in the development of regulatory guidelines and policies for medical devices. His expertise extends to serving as a resource person for various in-house training programs at the FDA and conducting foreign audits/inspections of medical device manufacturing facilities to ensure compliance with GMP and QMS Standards.

Josh Egba

Country Representative, West Africa

U.S. Trade and Development Agency

Modetator

Joshua Egba serves as a U.S. Trade and Development Agency (USTDA) country representative based in Lagos, Nigeria where he provides program support and contributes to strategic planning and business development in the West African region. He is a member of the agency’s Healthcare and Agribusiness sector teams.

Prior to joining USTDA, Mr. Egba was a business consultant, providing technical assistance for public and private sector entities including the Central Bank of Nigeria and Nigeria’s Federal Ministry of Industry, Trade and Investment. His prior professional experience included serving as a Finance Officer where he prepared budgets and financial statements for Wakefield & District Housing, a registered social landlord in the United Kingdom (UK), as well as serving as a Credit Risk Advisor for British telecoms firm O2 in Leeds, UK.

He holds a Master of Science degree in International Business from London Southbank University and a Bachelor of Science degree in Economics from University of Jos.

Mirette Abskharoun

Regulatory Affairs Associate Director , Middle East & Africa (MEA)

Johnson & Johnson

Mirette Abskharoun, is the Regulatory Affairs Associate Director for Middle East & Africa region at Johnson & Johnson Medical Device company.

Mirette is the vice chair for Mecomed industry group for MEA region, with the objective of working towards bringing together healthcare stakeholders to foster good citizenship, encourage value-based healthcare, and work proactively with governments to increase patient access to the latest, cutting-edge industry innovations.

Prior to joining J&J, she was Regulatory Affairs at Egypt Ministry of Health working for Medical device registration department at EDA (Egyptian Drug authority) for five years.

She started her career at the Regulatory Affairs field to ensure Medical device safety and efficacy before placing the product on the market, learning EU/US and other GHTF Medical device regulation for product compliance.

Mirette was graduated as a Pharmacist from the Cairo University of Egypt. She was Enrolled in Global Regulatory Affairs Certificate Course at Northeastern University's College of Professional, USA. Also Granted RAPS certificate for Medical device.

Dr. Tolulope Adewole

Managing Director & CEO, Nigerian Sovereign Investment Authority

MedServe (an NSIA company)

Dr. Tolulope Adewole is a highly regarded healthcare expert with over two decades of diverse experience, ranging from clinical practice to leadership in the C-suite. His academic journey began at the University of Ibadan, followed by a medical internship at Lagos University Teaching Hospital and a Residency Program in Chemical Pathology at the University College Hospital, Ibadan, where he earned a Fellowship from the National Postgraduate Medical College. Beyond medical practice, Dr. Adewole completed a Healthcare Management certificate program at the University of Washington and is a distinguished member of professional organizations like the American Association of Clinical Chemists. In 2019, Dr. Adewole became the CEO of NSIA Healthcare Development & Investment Company (NHDIC), overseeing projects valued at US$21M in Cancer care and Diagnostics across Nigeria's regions. Currently, he serves as Chairman of the Board for NSIA LUTH Cancer Center and NSIA Kano Diagnostic Center, holding positions on the Board for NSIA Umuahia Diagnostic Center. Dr. Adewole is recognized for his financial acumen in the healthcare sector, serving on the Finance Committee for the Healthcare Federation of Nigeria and on the Board of Directors for Covenant University. He is a Member of the Institute of Directors. Dr. Adewole's reputation extends globally, as a respected expert in healthcare matters. Acknowledged by prestigious bodies, including the Institute of Directors, Society for Quality in Healthcare, and International Society for Immunotherapy of Cancer (SITC).

Prof. Moji Adeyeye

Director General

National Agency for Food and Drug Administration and Control (NAFDAC)

Joseph Rieras, J.D.,

Director of the Office of Trade and Global Partnerships (OTGP)

U.S. Food and Drug Administration

Khatija Suleman

Head of Regulatory Affairs

Becton Dickinson

Khatija Suleman is a pharmacist and clinical pharmacologist with 35 years of experience and expertise in various sectors of the healthcare industry from a wide range of roles and responsibilities. She currently holds the position of Vice Chairperson of the Regulatory Committee at the South African Medical Device Industry Association (SAMED) and is the Head of Regulatory Affairs for Africa at Becton Dickinson, a global medical technology company. She actively contributes to enhancing and shaping regulatory frameworks that supports innovative healthcare delivery and patient safety.