Regulatory Capacity Building Workshop:
Vaccine Clinical Trial Review from Ebola to HIV
Working with African National Regulatory Authorities to assist the enhancement of their review capacity for HIV clinical trials and other urgent public health challenges.
The high burden of HIV/AIDS still present in different regions of Africa, combined with the variance in the subtypes of HIV among these regions, means that the development of vaccine strategies will require clinical trials in each of these regions. These important trials must be reviewed by the local National Regulatory Authorities (NRAs), which typically operate in resource constrained environments.
With new HIV vaccine trials in development, Health Canada, the Global HIV Vaccine Enterprise and the Canadian HIV Vaccine Initiative (CHVI) Alliance Coordinating Office are hosting a three-day regulatory capacity building workshop in collaboration with the World Health Organization (WHO) and African regulatory agencies. This workshop will bring together regulators and agencies engaged in regulatory capacity building to discuss pathways forward to meet the regulatory challenges associated with new and potentially more complex HIV vaccine clinical trials in Africa.
While the context for the workshop is the upcoming HIV clinical trials, the approach will be to look at strategies recently employed to overcome resource constraints faced by NRAs through the use of joint review processes with other vaccine trials. To this end, the lessons learned through ongoing Ebola vaccine clinical trial reviews as well as recent joint reviews for vaccines against other pathogens will be explored.
At the Global HIV Vaccine Enterprise’s Funders’ meeting held in 2014, funders agreed that multiple efforts are being made to improve regulatory capacity in countries where HIV vaccine trials are underway, but that it would be worthwhile to improve information sharing among the different groups involved in this general effort. During the first day of the workshop, agencies currently involved in capacity building in Africa (including WHO, Health Canada, AVAREF, the Gates Foundation, HVTN, IAVI and others) will be convened to explore how information sharing and opportunities for collaboration and coordination can be better supported.
- Map out the current and future regulatory capacity building efforts in Africa.
- Share lessons learned from recent joint vaccine clinical trials and exploring the transferability of these to the upcoming HIV vaccine clinical trials.
- Identify current challenges and opportunities within and among African NRAs with respect to joint clinical trial reviews.
- Implementation of good review practice and risk benefit evaluation principles for review.
- A report with proposed recommendations (e.g. regulatory capacity building for NRAs and for donors) will be produced to share with participants and key stakeholders
Date and location
A three-day meeting to be held in Kigali, Rwanda, 18-20 March 2015.
- Dean Smith, Health Canada, Canada
- Miga Chultem, Health Canada, Canada
- Dicky Akanmori, World Health Organization, Democratric Republic of Congo
- Tusubira K Evans, NRA, Uganda
- Zinhle Makatini, South Africa Medicines Control Council, South Africa
- Bill Snow, Global HIV Vaccine Enterprise, United States
- Amapola Manrique, Global HIV Vaccine Enterprise, United States
- Bargavi Thyagarajan, Global HIV Vaccine Enterprise, United States
- Christine Cryan, Public Health Agency of Canada, Canada
- Deborah Douglas, Alliance Coordinating Office, Canada
- Renée Barclay, Alliance Coordinating Office, Canada
- Crystal Brown, Alliance Coordinating Office, Canada