Monday, 27 November 2017 07:00-08:30
Registration
08:30 – 10:00: Opening Ceremony
Master of Ceremony: Margareth Ndomondo-Sigonda, NEPAD Agency and Thomas Lapnet-Moustapha, World Health Organization (WHO)
Rapporteurs: Janet Byaruhanga (NEPAD Agency) & Jean Baptiste Nikiema (WHO)
Dr. Xavier Crespin, Director General, West Africa Health Organization (WAHO)
Immanuel Mujuru, Chairman, Federation of African Pharmaceutical Manufacturers Associations (FAPMA),
Thomas Cueni, DG, International Pharmaceutical Manufacturers Associations (IFPMA)
Andreas Seiter, World Bank,
WHO Representative, Ghana
Dan Hartman, Director, Integrated Development, Global health, Bill and Melinda Gates Foundation (BMGF)
Aggrey Ambali; Head; Industrialization, Science, Technology and Innovation (ISTI); NEPAD Agency
Gugu Mahlangu, Director General, Medicines Control Authority of Zimbabwe and Chairperson, African Medicines Agency (AMA) Task Team
H.E. Dr. Amira Elfadil Mohamed, Commissioner for Social Affairs, African Union Commission (AUC)
Hon Kwaku Agyeman-Manu, Minister for Health, Republic of Ghana
10:00 – 10:30
Group Photo
10:30 – 12:30: Plenary Session I: Harmonisation of regulation of medical products in Africa, where are we?
Session Co-Chairs: Delese Mimi Darko, CEO – Ghana FDA & Samvel Azatyan, WHO
Rapporteurs: Ossy Kasilo (WHO) & Paul Tanui (NEPAD Agency)
AMRH Programme: Continental Progress Update, Margareth Ndomondo-Sigonda, NEPAD Agency
Progress on Regulatory Harmonisation in East African Community (EAC), Jane Mashingia, EAC Secretariat
Progress on Regulatory Harmonisation in Southern African Development Community (SADC), Joseph Mthetwa, SADC Secretariat
Progress on Regulatory Harmonisation in the Economic Community of West African States (ECOWAS), Sybil Nana Ama Ossei-Agyeman-Yeboah, WAHO
Progress on Regulatory Harmonisation in the Intergovernmental Authority on Development (GAD), Fatuma Adan, IGAD Secretariat
Progress on Regulatory Harmonisation in the Central Africa Economic and Monetary Community of Central Africa (CEMAC), Aime Djitafo Fah, The Organization for the Fight Against Endemic Diseases in Central Africa (OCEAC)
“AMRH”, Are We Making Progress? David Mukanga, BMGF
Discussions and recommendations Moderated by Session Chairs
12:30 – 14:00 Lunch
14:00 – 15:30: Plenary Session I (Continued): Harmonisation of regulation of medical products in Africa, where are we?
Session Co-Chairs: Robert Ndieka, AUC & David Mukanga, BMGF
Rapporteurs: David Matle (TFDA) and Godfrey Keele (FAPMA)
Result-Oriented Monitoring of Medicines Regulatory Systems and Harmonization Initiatives in Africa, Chimwemwe Chamdimba, NEPAD Agency Experience in aligning global submissions with regulatory reviews across mature and developing NMRAs Lawrence Liberti, Director, Centre for Innovation in Regulatory Science (CIRS)
Discussions and recommendations, Moderated by Session Chairs
16:00 – 17:30: Plenary Session II: Learning from other harmonisation and collaborative efforts, and partnerships for regulatory harmonisation
Session Co-Chairs: Mike Ward, WHO & Hiiti Sillo, TFDA
Rapporteurs: Paul Tanui & Apollo Angole
The European Medicines Agency (EMA) – the role of Article 58 and collaborative registration procedures in facilitating regulatory approval in Africa Martin Harvey, EMA
Asia-Pacific Economic Cooperation (APEC) regulatory harmonization experiences in Regulatory Harmonization Dr Alan Bollard, Executive Director, APEC
WHO collaborative registration procedures for promoting regulatory harmonization in Africa, Luther Gwaza, WHO
Presentation based on abstract submission, TBD
Discussion and recommendations Moderated by Session Chairs
17:30 END OF DAY ONE
Tuesday, 28 November 2017 8:00 – 8:30
Report of Day 1 and introduction to workshops; Jean Baptiste Nikiema & Ossy Kasilo, (WHO)
10:30 – 13:30: Plenary Session III: Expanding the scope for regulatory harmonisation in Africa – opportunities and challenges
Session Co-Chairs: Dan Hartman (BMGF) and Jean Baptiste Nikiema (WHO)
Rapporteurs: Godfrey Keele (FAPMA) and Nancy Ngum (NEPAD Agency)
Life Cycle Management (LCM)/Variations (10 min) IFPMA Perspective
A Framework for Alignment of Regulatory Systems Strengthening and Harmonization Initiatives in Africa (10 min) Paul Tanui, NEPAD Agency
The role of Network of Official Medicines Control Laboratories–Africa in strengthening regulatory capacity in Africa (10 min) USP Representative
The African Vaccines Regulatory Forum (AVAREF) Efforts in Strengthening Capacity for Clinical Trials Oversight and Ethics Clearance (10 min) Dicky Akanmori, WHO
Discussion and recommendations (20 min) Moderated by Session Chairs
Plenary session III:B
Pan African Harmonization Working Party (PAHWP) efforts for medical devices and diagnostics capacity strengthening (10 min) Hiiti Sillo, DG-TFDA
Paul Ehrlich Institute (PEI)-Blood and Blood Products efforts to strengthen regulatory capacity in Africa (10 min) Washington Samukange, Paul-Ehrlich-Institut Global Health Programme
Emerging Health Technologies: A Case for Malaria Eradication (10 min) Hudu Mogtari, for NEPAD Agency
Discussion and recommendations (30 min) Moderated by Session Chairs
13:30 – 14:30 Lunch
14:30 – 16:00 Plenary Session IV: Shaping the future of medical products regulation in Africa: Sustaining the momentum after 10 years of harmonisation efforts
Session Chair: Gugu Mahlangu, Medicines Control Authority of Zimbabwe
Rapporteurs: Paul Tanui, NEPAD Agency and TBD Hidaya Juma Hamad (ZFDB)
The AMRH Partnership Platform (APP), Nancy Ngum, NEPAD Agency
WHO update on the Global Coalition of Interested Partners (CIP), Mike Ward, WHO
The African Medicines Agency, Janet Byaruhanga, NEPAD Agency
Discussion and recommendations, Moderated by Session Chairs
16:00 – 16:30 Tea/Coffee Break
16:30 – 18:00: Closing Ceremony
Master of Ceremony: Margareth Ndomondo-Sigonda, NEPAD and Thomas Lapnet Moustapha, WHO
Rapporteurs: Chimwemwe Chamdimba & Janet Byaruhanga
Presentation of conference recommendations, Chimwemwe Chamdimba
Discussion on conference recommendations, All
Partners Remarks, FAPMA, IFPMA & BMGF
Remarks from WHO, WHO Representative, Ghana
Closing Remarks, NEPAD Agency, Prof Aggrey Ambali
18:00 End of Conference
27th Nov 2017
08:00 to 20:00 UTC±00:00
Accra
3rd Biennial Scientific Conference on Medical Products Regulation in Africa #SCoMRA
A summary of the key messages at the 3rd Biennial Scientific Conference on Medical Products Regulation in Africa #SCoMRA which took place in Accra, Ghana in November 2017.
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Q&A 1: Regulation harmonization — Africa's blueprint for health care success
When it comes to medical products and pharmaceuticals, countries required to have a system that regulates those products, authorizes what can enter their market, and prevents substandard and falsified medicines from reaching healthcare facilities.
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Q&A 2: Towards Medicines Regulatory Harmonization Lessons from Zimbabwe
The lack of regulatory synchronization not only delays patient access to medicines, but it can often mean that poor-quality, or even substandard and falsified medicines, make their way into the hands of patients, potentially causing serious damage.
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Short video teaser_3rd Biennial Scientific Conference on medical products regulation in Africa
This is the short version of the video teaser promoting the 3rd Biennial Scientific Conference on medical products regulation in Africa. The theme of the Conference in 2017 is sustaining the momentum for regulatory harmonization in Africa.
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