Regulatory
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
References
- 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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If you are a researcher who would like to submit a query to the Regulatory working group, please email WorkingGroups@covid19crc.org with “Regulatory” in your subject heading.