📢 🔔Take a look at the below ‘Call for Expressions of Interest’ from the Multi-stakeholder Platform Advisory Group (MSP AG) under ACT EU:
▶️ Message from ACT EU: MSP AG
“Call for Expression of Interest – Focus Group on the review of the Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol”
Following three years of experience with the implementation of the Clinical Trials Regulation (CTR), and in response to requests to update the Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol, the Serious Breaches expert subgroup is proposing a revision of this guideline to ensure it is clearer, more comprehensive, and fit for purpose.
To support this activity, a dedicated focus group will be established, comprising representatives from non-commercial sponsors and commercial sponsors. The purpose of the focus group is to review the updated guideline identify any areas requiring clarification and propose any further improvements, as appropriate.
We invite expressions of interest from:
📍 Two non-commercial representatives, and Two commercial representatives,
with practical experience in the assessment and/or reporting of serious breaches.
⏱️ Indicative timeline of focus group activities:
➡️ Kick-off meeting: 2nd half of March
➡️ Written comments on the guideline: three weeks following the kick-off
➡️ Consolidation of comments: two weeks
➡️ Discussion and potential implementation of comments: 2nd half of April
➡️ Additional ad hoc meetings may be convened if required
➡️ The focus group is expected to conclude its work by May
Expressions of interest should be submitted to:
➡️ msp-agsecretariat@ema.europa.eu
➡️ by 4 March (end of business)
➡️ including a short biographical note outlining the nominee’s relevant experience and suitability for participation in the focus group.