AVAREF Webinars
AVAREF is based on the Pan-African Clinical Trials Partnership (PACTA) principle, which brings together Ethics Committees (ECs), National Regulatory Authorities (NRAs), the Pan-African Clinical Trials Registry(PACTR) and other partners involved in product development and clinical trials. The key partners of AVAREF provide financial and technical support to AVAREF. Partners participate in all Steering Committee and Technical Coordinating Committee meetings to plan and implement activities with the AVAREF Secretariat, providing expert advice and support. Partners fall into three broad categories:
As part of the AVAREF Action Plan developed in response to the COVID-19 pandemic, the Secretariat organized a series of weekly webinars for ethics committees and regulatory authorities of the 55 African Member States, partners, researchers, scientists, product developers, members of product development partnerships, funding agencies, and other relevant stakeholders from the region and beyond.
These webinars brought together experts from around the world to share information about how to harmonize the review and processing of COVID-19 clinical trial applications. All webinars were well attended and typically included short remarks by a senior WHO official, followed by an AVAREF partner, a 45- to 60-minute presentation, 30 minutes of discussion and questions, and closing remarks by the moderator, selected from the AVAREF Technical Coordinating or Steering Committees. Each webinar can now be viewed online here.
AVAREF continues to host monthly webinars to help build the capacity of African regulators and ethics committees. Held on Thursdays from 2:00pm – 3:30pm GMT, these monthly forums attract regulators and ethics committee members across the African continent.
Past webinars can be viewed below. To find out about upcoming webinars, please stay connected by checking the website.
Joint Review Procedure for Clinical Trials and Facilitated Emergency Use Authorization of COVID-19 vaccines, 3 June 2021 (passcode is available upon request)
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14 March 2023
Ensuring transparency and accountability: PACTR's impact on clinical trial registration in Africa
The South African Medical Research Council recognizes the catastrophic and persisting consequences of colonialism and
apartheid, including land dispossession and the intentional imposition of educational and health inequities.
Acknowledging the SAMRC’s historical role and silence during apartheid, we commit our capacities and resources to the continued promotion of justice and dignity in health research in South Africa.
- Webinar / Passcode: S$!b4JbJ
- Download the presentation
29 September 2022
Monkeypox - Epidemiology and Vaccine Strategy
In this webinar, Dr Daniel Câmara, WHO AFRO, shared Monkeypox epidemiology and transmission data in the African continent.
Professor Mark Loeb from McMaster University, Canada, introduced a vaccine strategy to address Monkeypox post-exposure prophylaxis.
25 August 2022
DAC Assessment Tool
In this webinar, a tool to ensure optimal design of clinical trials, the DAC Assessment Tool for Clinical Trials was introduced. NAFDAC shared their experience with the Digital Platform and Informativeness Assessment Tool for Regulatory Review of Clinical Trial Applications.
The tool is designed to improve/maximize informativeness of the clinical trial from the quality of the clinical trial design.
3 June 2021 (passcode is available upon request)
Joint Review Procedure for Clinical Trials and Facilitated Emergency Use Authorization of COVID-19 vaccines
In this webinar, the AVAREF Secretariat presented the AVAREF Joint Review Procedure for Clinical Trials as well as WHO/AFRO Facilitated Emergency Use Authorization of COVID-19 Vaccines. Also, sponsors and developers of new vaccines were invited to share their experience with the joint reviews facilitated by the AVAREF.
27 August 2020
What COVID-19 Has Taught Us About Vaccine Manufacturing in Africa
Prof William Kwabena Ampofo, Chairperson, African Vaccine Manufacturing Initiative (AVMI)
In this webinar, the Chairperson of the AVMI sheds light on the current status of vaccine manufacturing in Africa, the future market, research and development in African institutions, the role of COVID-19 in bringing the issue of vaccine nationalism to the fore, the influence of anti-vaccine lobby groups, and the need for an African Vaccine Manufacturing plan endorsed by the African Union. The webinar features a lively discussion, during which a delegation from the Federal Ministry of Health of Ethiopia seeks support for their country’s plan to manufacture vaccines.
13 August 2020
Experiences of Ethics Committees/Regulators from Outside Africa on COVID-19 Related Clinical Trials
Dr Peter Marks, Director, US FDA, Center for Biologics Evaluation and Research (CBER)
In this webinar, the Director of the US FDA’s CBER shares information about the center’s work on developing COVID-19 products, focusing on vaccine development and the use of convalescent plasma against COVID-19 in the USA. The presentation also highlights CBER’s efforts to develop and disseminate a guidance document for developers, outlining the US FDA’s expectations for the clinical development of COVID-19 vaccines.
30 July 2020
Therapeutics against COVID-19: Treatments and Medicines in Clinical Trials
Dr Vaseeharan Sathiyamoorthy, Coordinator, Science Division, Research for Health Department (HQ/SCI/RFH), World Health Organization
This webinar, presented by the WHO HQ Blueprint Team responsible for managing the Global Solidarity Trials for COVID-19 therapeutics, explains the trial’s design, lists the countries involved, and shares preliminary results.
**This webinar was not recorded for confidentiality reasons.
16 July 2020
Regulation of Clinical Trials of Herbal Medicines
Dr Ossy MJ Kasilo, Regional Advisor for Traditional Medicine and Focal Point for Medicines, Medical Products and Devices (AF/RGO/ULC/MIM), World Health Organization
Dr Charles Wambebe, Founding President of International Biomedical Research in Africa, Chair of Product Research and Development for Africa (PRADA)
Several herbal medicines are being investigated in clinical trials in African countries, making this an important area of work in the African region. This webinar discusses requirements for traditional or herbal medicine clinical trials, using a specific product that underwent clinical trials and was approved as an example.
25 June 2020
Development and Manufacturing of COVID 19 Vaccines: CEPI’s Pipeline and Activities
Dr Jakob Cramer, Head of Clinical Development, Coalition for Epidemic Preparedness (CEPI) Dr Svein Rune Andersen, Head of Regulatory Affairs Europe, CEPI
A pre-existing AVAREF-CEPI partnership facilitated this presentation, in which CEPI, a major developer of vaccines against COVID-19, highlights its work. This work extends from vaccine development to supporting manufacturing plants as they prepare to mass-produce vaccines, to ensure global access.
18 June 2020
Safety in Clinical Trials and Post-registration: The 3S Strategy
Dr Raj Long, Deputy Director, Integrated Development, Global Health, Bill & Melinda Gates Foundation Dr Aggrey Ambali, Supervisor, Technical Cooperation, Programme Funding and Strategic Initiatives, AUDA-NEPAD
This webinar, jointly presented by AUDA-NEPAD and the Bill & Melinda Gates Foundation, addresses medical product safety, from clinical development to licensure and post-licensure. It highlights the need for regulatory vigilance, especially amidst the rapid clinical developments of the COVID-19 pandemic. The need for a common platform in the region to share data on adverse events, as exists in other regions, is discussed.
11 June 2020
Basic Interpretation of Measures of Association (OR, RR, HR): Distinguishing Association and Causation
Dr David Mukanga, Senior Program Officer, African Regulatory Systems, Bill & Melinda Gates Foundation
This webinar provides clarity on the measures of association at the heart of epidemiologic and interventional studies, which are so often relied upon by investigators, regulators, and ethics committees in decision-making
04 June 2020
Design, Analyze, and Communicate (DAC) – A Tool for Efficient Protocol Review
Dr Thea Norman, Senior Program Officer, Bill & Melinda Gates Foundation
Shawn Dolley, President of Open Global Health
Given the limitations the pandemic has placed on holding the face-to-face meetings typically used to review clinical trial applications, the DAC Tool presents a welcome opportunity to support regulators and ethics committees in the region considering switching to electronic management of review processes. This webinar discusses the tool, whose development was catalyzed by earlier meetings with the AVAREF Steering and Technical Coordinating Committees.
28 May 2020
AVAREF Emergency Review Process, Designed to Address COVID-19 Product Development
Dr Beno Nyam Yakubu, Assistant Director, Nigeria National Agency for Food and Drug Administration and Control
Dr Edward Abwao, Head of Clinical Trials, Kenya Pharmacy and Poisons Board
In May 2020, AVAREF developed and endorsed an emergency joint review process, to be conducted in 10 days for previously registered medical products and 15 days for novel products. This webinar explains the process clearly, identifying all stakeholders’ roles and responsibilities in order to gain buy-in for the new process.
21 May 2020
AVAREF Joint Review Process and Digital Survey Findings
Dr Diadié Maïga, Technical Officer, Vaccine Regulation, WHO AFRO
Eun Mi Kim, Technical Officer, Vaccine Regulation & Safety, WHO AFRO
This webinar offers an update on the African continent’s readiness to conduct reviews and oversee clinical trials. It helps set the stage to guide countries to address clinical trials of COVID-19 products with appropriate urgency. It also reviews core functions of AVAREF’s support for efficient reviews of clinical trial applications, conducted according to predictable timelines.
14 May 2020
Basic Virology and Targets for Vaccines and Therapeutics
Prof BD Akanmori, Regional Advisor, Vaccine Regulation, WHO AFRO
Dr Jacob Samson Barnor, Technical Officer for Poliovirus Containment, WHO AFRO (PEP)
In this webinar, the presenters discuss current knowledge and understanding of SARS-COV-2, as well as the justification for vaccine candidates in early development and therapeutics in clinical trials.