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Regulatory Affairs News – The first MHRA focus group meeting

By March 11, 2022No Comments

The first MHRA focus group meeting

Those of you who attended the Regulatory Affairs Working Party meeting on Thursday 3rd March, you will have heard that the introductory meeting for MHRA’s focus groups occurred on Monday 7th March.

The aim of these focus groups is to help develop guidance in relation to the new UKCA regulations and provide insight into key changes. They are split by stakeholder area (patient groups, trade associations and industry, approved bodies, clinician representatives, and devolved administrations), and each session will focus on a different topic relevant to the new regulations.
It’s important to note that these groups are not for changing the regulation itself, but major concerns can still be flagged through this platform.

BIVDA will be attending the trade association and industry meetings, using our response to the MHRA consultation (here) as a basis for our views.

The timetable of scheduled meetings and each topic that will be covered is below, noting that each session is intended to span two topics (45 minutes for each one). Topics which BIVDA is not intending to contribute to are in grey. This timetable is not final, and is being amended based on feedback in the introduction session that we would prefer meetings to be more frequent.
MHRA have indicated that subject matter experts are welcome to join the meetings where they can input to the conversation. No maximum capacity of experts has been given, but MHRA has asked to be informed in advance if this will be more than two for a trade association. If you think you can feed into the below discussions on a significant level and would like to volunteer, please contact Ashleigh. We will also be sending a summary of each meeting and a reminder about the next meeting in the weekly Regulatory Affairs updates and in the Newsletter.
As always, members are encouraged to reach out to BIVDA to flag concerns or queries they have in relation to regulation, and we will do our best to support you.

 

***Please find the topics and timelines information on these slides. 

Michael

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