Module 1 2021

28/06/2021

How to seek Agency advice?

Define strategy within the company • Agree within the company the purpose and scope of advice sought • Ensure agreement and understanding regarding route of advice and selected agencies • Establish agenda, clear questions, critical issues and quality briefing pack • Establish professional relationships and credibility with target agencies/assessors • Challenge based on science and respect • Manage internal expectations of success and potential impact on strategy Decision and process led by Regulatory Affairs?

The Organisation for Professionals in Regulatory Affairs

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Plan for Agency Interactions

Participants • Agree process and meeting roles, including leadership • Type of meeting, f2f or teleconference • Agree company attendees • limited number • key contributors • consider the unexperienced • Consider the role of the local affiliate company • Consider use of external experts, KOLs

The Organisation for Professionals in Regulatory Affairs

28

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