Meeting 3: Mutual Recognition Agreements in the Regulation of Medicines
July 10, 2019 from 8:30am - 4:00pm (British Standard Time)
In this public session of information gathering, regulatory leaders will share challenges and opportunities for improving the exchange of information between national/regional regulatory authorities, the use of exchanged information, and the scope of exchanged information. Presentations will be 8-10 min each and guided by the following questions:
- Challenges with the exchange of information between regulators and how they have/have not been addressed: How could things work better and what needs to be done?
- Challenges in using exchanged information in informing their own regulatory decisions and how they have/have not been addressed: How could things work better and what needs to be done?
- Opportunities for increasing the scope of regulatory activities (beyond GMP inspection reports) that would be/have been amenable to reliance on exchanged information : Are there specific areas that would be/have been relatively easy to address (e.g., API/GCP/GLP inspections; laboratory analyses for various regulatory purposes; PSUR assessment reports, bioequivalence study assessment reports, animal toxicology assessment reports, microbiology assessment reports; others)
The presentations will be followed by a facilitated conversation, by committee members.
To join the meeting: https://www.bethereglobal.com/nas-071019