Meeting

Meeting 3: Mutual Recognition Agreements in the Regulation of Medicines


When: July 10, 2019 (9:00 AM GMT+1)
Where: Bill & Melinda Gates Foundation London Office (5th Floor) • 62 Buckingham Gate

Topics Global Health, Public Health, Health Security
Activity: Mutual Recognition Agreements in the Regulation of Medicines
Board: Board on Global Health

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

 

Upcoming Meetings for this Activity

Previous Meetings for this Activity

Also of Interest