CRED 8 Presentations

01/07/2024

Maximise effectiveness of advice

• If you don’t want to hear the answer, don’t ask the question • No open questions, but ask specific questions and provide your own position (NB: if your own opinion is not provided the request for SA will not be validated by the MEB). In case questions are not clearlyformulated you will be asked to reformulate X Here is the whole clinical programme; is it acceptable?  Does the agency agree that X is a valid end-point? X What impurities should be controlled in the specification  Does the agency agree that impurity Y is controlled at NMT Z% X Can the MEB provide under which legal basis the MAA should be submitted  The company would propose to submit the MAA under legal basis xxx based on the following argumentation

The Organisation for Professionals in Regulatory Affairs

17

Maximise effectiveness of advice

For the face-to-face meeting (still very rare F2F meetings) and TCs • Presentation should focus on key issues, other issues are handled in written final advice • Choose attendeescarefullyand in relationshipto the questions asked • Be prepared to listen as well as to respond to clarification questions

The Organisation for Professionals in Regulatory Affairs

18