Overview
Countdown to Event :
December 5, 2022 08:00:00- days
- Hours
- Minutes
- Seconds
- Overview
-
The African Medicines Regulatory Harmonization (AMRH) Week is an event convened every two years by the AMRH Joint Secretariat which comprises the African Union Development Agency-NEPAD (AUDA-NEPAD) and the World Health Organisation (WHO) with support from the African Union Commission (AUC). The ‘week’ brings together high-level African leaders and policy makers, members of AMRH Steering Committee (AMRH SC), Regional Economic Communities (RECs) the AMRH Technical Committees (AMRH TCs), the AMRH Partnership Platform (AMRH PP) as well other partners and stakeholders to showcase and celebrate the successes of AMRH as well as to reflect on progress, challenges and identify opportunities for continued improvement.
The inaugural AMRH Week took place in Kigali, Rwanda in December of 2018 and was a key moment of celebration of a decade of AMRH’s success and an opportunity to align with stakeholders on the coordination and collaboration needs in the medicines regulatory space across the African continent. The event was highly successful, with participation and support from the Minister of Health in Rwanda as well as many other senior officials from AUDA-NEPAD, AUC, WHO and development partners.
Two years later, the 2nd AMRH week took place under completely different circumstances, with the world being at the height of a global health crisis due to the emergence of COVID-19 as a pandemic. The event was held virtually, as many countries were abiding by forced lock down measures to contain the spread of the virus which brought on a massive loss of lives and livelihoods all over the world. Due to the circumstances under which it was held, the event which was attended by over 120 participants, focused mainly on strategies for regulatory preparedness and response during public health emergencies.
National Regulatory Authorities (NRAs) across the globe, and especially in Africa and other low- and middle-income countries faced many challenges in ensuring access to quality assured medical devices, in-vitro diagnostics, personal protective equipment (PPEs) and other health products to control COVID-19. In response to these challenges, and under the guidance of the AMRH Steering Committee, the AMRH TCs provided accelerated technical support and assistance to address some of the challenges highlighted, through coordinated efforts with the member states.
Despite these many challenges, the 2nd AMRH Week also celebrated the good work done by regulators and ethics committees in facilitating COVID-19 clinical trials reviews and subsequent approvals by NRAs, monitoring of the safety of vaccines, as well as listing of medical devices including in vitro diagnostics and manufacturers of medical devices and PPEs as part of COVID-19 response. Regulators also shared their experiences on various regulatory pathways, the use of regulatory reliance and collaboration employed to address COVID-19 challenges.
- Specific Objectives
-
-
To take stock of the progress made in the implementation of recommendations from the second AMRH week.
-
To highlight regulatory response to COVID-19 by NRAs, including promoting access to diagnostics and clinical trials of vaccines and therapeutics on the continent.
-
To articulate the strong collaboration, networking and partnerships built through the TCs of the AMRH.
-
To strengthen and build partnerships and collective action by all stakeholders for the operationalization of the AMA.
-
To launch the reports on access to ARVs in selected African Countries and the current state of development of the local pharmaceutical manufacturing and regulatory capabilities in the Africa Union.
-
- Expected outcome
-
Coordinated partnerships, increased collaboration, and strengthened commitments made among AMRH stakeholders and partners in support of regulatory systems strengthening and harmonisation efforts in Africa.
- Activities during the Third AMRH Week
-
-
The EAC and IGAD MRH HoA meeting on Reliance Frameworks Monday, 05 December 2022
-
The AMRH TC meetings: AMQF, AMDF, GMP, MPRR, EMP, on Tuesday and Wednesday, 06 - 07 December 2022
-
The RCD TC meeting on 06 December followed by Annual RCOREs Conference, 07 December 2022
-
The AMRH Partnership Platform (AMRH-PP) business meeting, launch the two reports on Africa’s pharmaceutical development and progress, followed by the AMRH Week Opening Ceremony, on Thursday, 08 December 2022.
-
The 11th AMRH Steering Committee (AMRH-SC) meeting, Friday, 09 December 2022.
-
- Participants
-
Participants will include policy makers and other senior government officials, leadership of AUDA-NEPAD, AUC, WHO, and Africa-CDC, the AMRH Steering Committee members, the AMRH TC members, the AMRH Partnership Platform members, leadership of the RECs Secretariats and the REC Coordinators
- Things to do while in Accra
-
SOUND OUT
Date | 3 - 9 December 2022
Time | 10am to 10pm each day
Sound Out – It’s a premium art exhibition that showcases not only art pieces but crafts made here in Ghana. It features both the old popular artistes as well as young up-and-coming artists and this year’s exhibition will hold at Underbridge, East Legon between the hours of 10am to 10pm each day from 3rd to 9th December 2022.For more information, Click Here
ARTS AND MUSIC
Organisers
Speakers
Hon Kwaku Agyemang-Manu
Minister of Health, Ghana & Chairperson, AMA Conference of States Parties
Ministry of Health: Ghana
Kwaku Agyeman-Manu born September 6, 1955, is a Ghanaian politician. He is the Member of Parliament for Dormaa Central and the Minister of Health. Kweku Agyeman-Manu is a Chartered Management Accountant and obtained a Bachelor of Arts in Economics and Statistics from the University of Ghana in 1989. Agyemang-Manu served as the Chairman of the Public Accounts Committee in the immediate-past Parliament and was the acting CEO of the National Health Authority in 2006, and also the Deputy Minister of Finance and Economic Planning under former President J. A Kuffuour’s administration (2001 to 2008), he served in various ministries as a Deputy Minister of State in the following Ministries: Trade and Industry, Interior, Finance, Communications, and Roads and Transport. He has served on the Boards of institutions such as the Small Arms Commission of Ghana, the Ghana Revenue Authority, Bank of Ghana, and the Divestiture Implementation Committee. President Nana Akufo-Addo named Kwaku Agyeman-Manu in May 2017, as part of the nineteen ministers who would form his cabinet.
Madame Nardos Bekele-Thomas
Chief Executive Officer
African Union Development Agency (AUDA - NEPAD)
Ms Nardos Bekele-Thomas is the CEO of the African Union Development Agency-NEPAD. She was previously the Senior Director of the Office of the Secretary-General. She also served in the capacity of Resident Coordinator for the United Nations in South Africa; Resident Coordinator and UNDP Resident Representative in the Republic of Kenya and the Republic of Benin. Prior to that she served for over four years in Kenya as Deputy Resident Representative. She holds a Master’s degree in Economic Development, Monetary Economics and Econometrics from New York University (NYU). She is the author of several papers and monographs, and she is fully bilingual in French and English. Ms Bekele-Thomas’ interests include the promotion of human development, anchored on the principles of economic, social and political rights for all. She has excelled as a Private Sector Policy Adviser focusing on the promotion of trade and investment in African countries through private/public sector partnerships in the United States. Ms Bekele-Thomas has also served in the technical and advisory capacity in which she helped initiate and conceptualise a pro-poor programme on the Social Dimensions of Development.
H.E. Amb Minata Samaté Cessouma
Commissioner: Health, Humanitarian Affairs and Social Development
African Union Commission (AUC)
She is a native of Burkina Faso with over thirty (30) years of experience in international relations, Diplomacy, Governance and peace and security, and humanitarian and social affairs. Previously at the continental level, Amb SAMATE CESSOUMA was the African Union Commissioner for Political Affairs from 2017 to 2021 during which she contribute to advancing the continental agenda for governance, democracy, human rights and stability in Africa. Prior to the above, she was Ambassador of Burkina Faso to Ethiopia, Permanent Representative to the African Union Commission (AUC) and the United Nations Economic Commission for Africa (UN-ECA) from December 2011 to May 2014, she successfully spearheaded key negotiations of the PRC and actively contributed to the outcome of framework agreements and decisions of the Executive council and the AU Assembly. Her Excellency Ambassador Samate is an enthusiastic career diplomat who is passionate about public service and the fight against the scourges of our continent. Her ardent will for a more integrated and peaceful continent, “The Africa We Want” and her commitment to good governance, peace and security and the promotion and protection of human rights and the rule of law, as well as her strong support for women and youth participation in governance processes in Africa, are some of her lifelong advocacies.
Dr Ahmed Ogwell Ouma
Acting Director
Africa CDC
Dr. Ahmed Ogwell Ouma is the Deputy Director of the Africa Centers of Disease Control and Prevention, the specialized Technical Institution of the Union charged with the responsibility to promote the prevention and control of diseases in Africa. Dr. Ouma is an accomplished international civil servant and an expert in global health. He has competency in governance in public health; partnerships and resource mobilisation; health security including health emergencies; the prevention and control of NCDs; building multi-sectoral partnerships; international co-operation across sectors; tobacco control; global health diplomacy; and development of international instruments that impact positively on public health. Dr. Ouma has worked globally for public health and has overseen implementation of country level policy in countries in Africa. He has been a pioneer in supporting governments in Africa to implement the WHO Framework Convention on Tobacco Control (WHO FCTC) and other international instruments for the prevention and control of NCDs.
Prof Julio Rakotonirina
Director: Health & Humanitarian Affairs Directorate
African Union Commission (AUC)
Professor Julio Rakotonirina is the Director of Health and Humanitarian Affairs Directorate at the African Union Commission since October 2022. Previously, Professor Julio was based in Madagascar where he worked through the health system, from Primary health care to Director of the University Hospital and in 2019/2020 he was the Minister of Public Health of Madagascar. He has over 20 years of experience working in developing countries, especially in Madagascar, Benin, and Comoros, as an Expert-Consultant, Medical Doctor, Specialist in Public Health (PhD) and Professor in Epidemiology. He has strong and evolving skills in health system management and in epidemic management. As a Researcher, he has worked with co-authors in research/evaluation and published scientific articles (www.researchgate.net/profile/Julio_Rakotonirina). He is actively involved in International and African multidisciplinary expert networks, including Demography Statistics for Africa (DEMOSTAF) project, the PERSUADE-II project and Partnership to enhance technical support for analytical capacity and data use for HIV, TB and Malaria in Southern and Eastern Africa.
Dr Ahmed Al-Mandhari
Regional Director for the Eastern Mediterranean
World Health Organisation (WHO)
Dr Ahmed Al-Mandhari was appointed as WHO Regional Director for the Eastern Mediterranean by WHO’s Executive Board at its 143rd session, and assumed office on 1 June 2018. Dr Al-Mandhari is a native of Oman and has made a substantial positive contribution to the development and modernization of Oman’s health system, which has witnessed qualitative improvements in recent years, particularly in areas such as patient safety.
Dr Matshidiso Rebecca Moeti
Regional Director
WHO-AFRO
Dr Matshidiso Rebecca Moeti is the World Health Organization (WHO) Regional Director for Africa. She is the first woman to be elected to this position and is now in her second term. Dr Moeti obtained her Bachelor of Medicine and Bachelor of Surgery degree from the University of London and a Master of Science in Community Health from the London School of Hygiene and Tropical Medicine. Over the past seven years, Dr Moeti has led a Transformation Agenda that is widely acknowledged to have improved WHO’s performance on emergencies, enhancing accountability and driving progress towards Universal Health Coverage. She leads WHO’s support to the COVID19 pandemic response in Africa. She is a medical doctor and public health expert with more than 41 years of national and international experience. Dr Moeti has worked with WHO for more than 20 years, and prior to this she worked with the Joint United Nations Programme on HIV/AIDS (UNAIDS) as Team Leader of the Africa and Middle East Desk in Geneva (1997–1999); with the United Nations Children's Fund (UNICEF) as Regional Health Advisor for East and Southern Africa; and with Botswana’s Ministry of Health as a clinician and public health specialist.
Prof Jean Baptiste Nikiema
Regional Advisor: Essential Medicines
WHO-AFRO
Jean-Baptiste Nikiema is Regional Adviser for Essential Medicines, EDM, WHO Regional Office for Africa, Brazzaville, Republic of Congo. He obtained his pharmacy degree in 1993 from ULB, Belgium. In 1997 he got a PhD in Pharmaceutical Sciences from the same University. Back to Burkina Faso, he was successively lecturer, associate professor and professor of pharmacognosy at the University of Ouagadougou and senior researcher at the Annigoni center for Biomolecular Research (CERBA). He was also engaged with the Ministry of Health, as responsible for the regulation of traditional medicines since 1998. Thereafter, he became successively Director of Traditional Medicine in 2002, Director of pharmaceutical procurement Directorate in 2008 and Director General of the National Medicines Regulatory Authority in 2011. He also served for four years as chairman of the Board of Centre Muraz, an institution specialized in Health research in general and particularly in clinical trials. In 2012, he joined the WHO Regional Office for Africa.
Prof. Mojisola Christianah Adeyeye
Director: General
NAFDAC and Chair of AMRH Steering Committee
Professor Adeyeye is the Director General (DG) of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) where she is leading regulatory and administrative reforms through quality management approach. She currently serves as the Chair of the Steering Committee of the African Medicines Regulatory Harmonization (AMRH) and the WHO-based Global Pediatric Regulatory Network. She earned her B.S from the University of Nigeria, Nsukka, Nigeria and MS and PhD from the University of Georgia, Athens, GA. She is an expert in research and drug development (R&D), bench-to-bedside translational research and regulatory science. She has mentored over 15 PhD and M.S candidates. She has 5 patents, 65 peer reviewed manuscripts, book chapters and books, and more than 140 scientific presentations.
Mrs Mimi Delese Darko
Chief Executive Officer
Ghana Food and Drug Authority, Republic of Ghana
Mrs. Delese Mimi Darko is the Chief Executive Officer of the Ghana Food and Drugs Authority. Mrs. Darko graduated from the Kwame Nkrumah University of Science and Technology (KNUST), where she was trained as a pharmacist. She later obtained a Master's degree in Business Administration from the University of Northampton. Mrs. Darko joined the Food and Drugs Board in the early 1990s. The organization was subsequently renamed the Food and Drugs Authority (FDA), and Mrs. Darko has served there in various capacities. In 2020, under Mrs. Darko's leadership, the FDA was recognized as a World Health Organisation Level Three listed institution. Some of the international and local advisory committees she serves on include, the CIOMS Vaccine Safety Working Group, the African Regulators’ Network, and the Technical Committee of the African Vaccines Regulatory Forum (AVAREF) of which she is the current chairperson.
Dr David Mukanga
Deputy Director
Africa Regulatory Systems, Global Health Division, Gates Foundation and Chairperson, the AMRH Partnership Platform
Dr. David Mukanga is Senior Program Officer Africa Regulatory Systems, where he leads the foundation's support and investments into regulatory systems in Africa. He holds a PhD in International Health.
Mr Hiiti Sillo
Head of Unit: Regulation and Safety
WHO-HQ
Hiiti Sillo is the current Unit Head, Regulation and Safety within the WHO department of Regulation and Prequalification. Until late 2021, he was the Team Lead, Regulatory Systems Strengthening (RSS) within the Regulation and Safety Unit. In his current capacity, he is responsible for coordinating WHO strategies for strengthening national and regional regulatory capacities, promoting regulatory networks, convergence, work-sharing and reliance as well as strengthening safety monitoring and addressing the global problem of substandard and falsified medical products. Before joining WHO in 2018, he was the Director General of the Tanzania Food and Drugs Authority (TFDA), the position he held since 2010 after serving on several technical and managerial positions within the TFDA and its predecessor, the Pharmacy Board of Tanzania. He also championed regulatory harmonization initiatives in Africa and particularly the launch of the African Medicines Regulatory Harmonization (AMRH) for the East African Community, the AMRH show-case. Mr Sillo is a Pharmacist and holds Master of Science in Pharmaceutical Services and Medicines Control.
Dr Margareth Ndomondo-Sigonda
Head: Health Programs
African Union Development Agency (AUDA - NEPAD)
Margareth Ndomondo-Sigonda, works for AUDA-NEPAD as the Head of Programme. She is responsible for providing technical leadership and strategic oversight on health and pharmaceutical programs such as the African Medicines Regulatory Harmonization (AMRH) Initiative, the establishment of African Medicines Agency as a specialized agency of the African Union (AU), and promotion of local production of pharmaceuticals in Africa. She currently leads the regulatory workstream of the AU Partnerships for African Vaccines Manufacturing (PAVM) Framework. She previously served as Chief Pharmacist and Registrar of Pharmacy Board of Tanzania (1998-2003) and as the first Director General of the Tanzania Food and Drugs Authority (2003-2010). She holds a PhD in Pharmacology from the University of the Witwatersrand, Johannesburg, South Africa.
Dr Boitumelo Semete
Chief Executive Officer
SAHPRA, South Africa
A passionate and driven health technology management leader with extensive experience in the local and regional Health Technology innovation sector building on a PhD in Biochemistry, background in R&D with publications in high impact factor journals and an MSc in Finance and Investment. I have successfully raised own funding for technology development, managed a portfolio of technologies and successfully supported commercialization of some of these technologies.
Mrs Chimwemwe Chamdimba
Principal Policy Specialist
African Union Development Agency (AUDA-NEPAD)
Chimwemwe Chamdimba is a Principal Policy Specialist at the African Union Development Agency (AUDA-NEPAD). She is responsible for health policy and regulatory reforms, regional harmonization and partner coordination. Chimwemwe has contributed to key continental policy processes including the African Union Model Law on Medical Product Regulation; the Treaty for the establishment of the African Medicines Agency (AMA); the AU Private Sector Engagement in Health Framework; the Science, Technology and Innovation Strategy for Africa (STISA-2024); and African Union Health Strategy. She is currently coordinating programmes on Health System Strengthening, TB, Occupational Health and Safety, and private sector engagement in health at the AUDA-NEPAD. She is leading partner engagement towards African Medicines Regulatory Harmonization (AMRH) technical support to the operationalization of AMA.
Dr Dan Hartman
Director Integrated Development
Gates Foundation
Dr. Dan Hartman leads a team that provides technical expertise in product development to other foundation teams and their partners. He joined the foundation in 2012 in his current role and served simultaneously as interim director of the Malaria team from 2016 to 2018. Dan has extensive management and pharmaceutical experience. Before joining the foundation, he served for four years as president and CEO of Great Lakes Drug Development, a consulting company providing strategic and operational support for early drug development projects. Previously, he served as senior vice president of product development at deCODE genetics, executive director of Pfizer Global Research and Development, and vice president of global clinical development at Esperion Therapeutics, and he held clinical research positions at Eli Lilly & Company. He has also provided consultation to the biopharmaceutical venture capital community and serves as a member/advisor on several nonprofit boards.
Venue Details
Tel: +233 30 277 2501-6
+233 547 141 662
+233 205 892 262
you agree to the AUDA-NEPAD Privacy Policy.