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Communications with Regulators Beyond Formal Meetings
Session Chair(s)
Khyati Roberts, RPH
Retired, Retired, United States
FDA and industry experts share best practices when seeking advice via Critical Path Innovation Meetings (CPIM), parallel scientific advice, and the Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT).
Learning Objective : Identify when you should seek advice beyond formal meetings with FDA; Discuss best practices in obtaining parallel scientific advice from FDA and EMA; Discuss best practices in obtaining advice via a Critical Path Innovation Meeting (CPIM); and, discuss the impact to regulatory strategies and timelines.
Speaker(s)
Overview of FDA-EMA Parallel Scientific Advice
Principal, Drug and Biological Products , ELIQUENT Life Sciences, United States
Seeking Advice from EMA
EMA Official at the FDA, European Medicines Agency, United States
Overview of Critical Path Innovation Meetings
Associate Director for Strategic Partnerships, OTS, CDER, FDA, United States
Industry Perspective on Communications Beyond Formal Meetings
Executive Director US Regulatory Policy & Intelligence , Novartis, United States
Overview of INTERACT Meetings
Associate Director for Review Management, CBER, FDA, United States
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