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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)
Sandra Kweder, MD
Principal, Drug and Biological Products , Eliquent Life Sciences, United States
Overview of FDA-EMA Parallel Scientific Advice
Tânia Teixeira, PharmD
EMA Official at the FDA, European Medicines Agency, United States
Seeking Advice from EMA
Chekesha Clingman, PhD, MBA
Associate Director for Strategic Partnerships, OTS, CDER, FDA, United States
Overview of Critical Path Innovation Meetings
Nicole Mahoney, PhD
Executive Director US Regulatory Policy & Intelligence , Novartis, United States
Industry Perspective on Communications Beyond Formal Meetings
Christopher Joneckis, PhD
Associate Director for Review Management, CBER, FDA, United States
Overview of INTERACT Meetings
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