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