Working group objectives
Facilitate rapid and joint protocol reviews and consideration of relevant import licenses by national regulatory agencies, through joint reviews for clinical approval and registration.
Working group members
- Lembit Rägo
- Beno Yakubu
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
- AVAREF Strategy and Guidance for Emergency Preparedness
- CIOMS statement: Medicines assessment during public health emergencies needs good science, best practices and proper communication
- Drug-induced liver injury (DILI): Current status and future directions for drug development and the post-market setting
- Considerations for Regulatory Oversight of Clinical Trials in the COVID-19 Pandemic by PAHO
- ICMRA statement on clinical trials
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