Module 1 2021

28/06/2021

Set Agency Interaction

Request for Agency meeting • According to applicable guidance/forms • Adequate information is very important for having successful outcome • Meeting objective • Product description • Questions grouped per discipline (CMC, noncling, clin) • Proposed meeting dates • Check availability of key company participants • Requested Agency participants

The Organisation for Professionals in Regulatory Affairs

29

Preparation Agency Interaction

Briefing pack – 2-4 weeks before meeting • Define clear process to prepare briefing pack • Leadership, contributors, reviewers, sign-off • List of questions (if not in request form) • Care with wording • Ask non-open questions • Does the Agency agree that [ state position ] • Clear briefing pack for submission – build the case • Agree clear messages • Create “skeleton” document

• Care with wording of positions to questions • Take guideline requirements into account

The Organisation for Professionals in Regulatory Affairs

30

15