Module 17 2024

05/12/2024

 They are not mind readers  Put together a briefing package  Background

 Medical need

 Purpose

 Is there a similar product

Information expectations

 Drawings

 Don't expect them to

have same mental vision as you

 Regulatory assessment

 Your strategy for gaining clearance  Proposed dossier structure

 Have you considered clinical trial need?

123

Expectations Formal vs. Informal meetings  There is an inherent expectation 

 Don't try to fit a square peg in a round hole

 Familiarize yourself with

scope, purpose, and format.  If you're not prepared, why should they be?

 If you didn’t provide the

information as requested don’t be surprised on outcome  Discussions are as important as documents. Print and intent can sometimes (often) be different.

124

62