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Session 6: Utilizing FDA’s Emerging Technology Teams and EMA’s Regulatory Support Tools During Product Development
Session Chair(s)
M. Scott Furness, PHD
Deputy Director, Office of New Drug Products, OPQ, CDER , FDA, United States
Kirsten Messmer, PHD, RAC
Owner, KM Intel LLC, United States
Advanced therapies rely on new and innovative technologies. It is paramount to discuss those modalities with regulators early in the product development to form a consensus on understanding the technology and regulatory requirements. The FDA and EMA have various teams that support these most innovative technologies. The session will provide an overview of opportunities to work with regulators to ensure a streamlined product development process that will comply with regulatory requirements.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify specific teams addressing innovative and developing technologies within regulatory agencies that support product development
- Develop an engagement plan to achieve maximum regulatory alignment
- Create an action plan to engage regulatory agency teams on innovative technology
Speaker(s)
Joel Welch
Deputy Office Director, OPQA III, OPQ, CDER, US FDA, United States
Speaker
Manuel Osorio, PHD
Senior Scientist for Emerging Technologies, FDA, United States
Speaker
Ana Hidalgo-Simon, DrMed
Associate Professor, Leiden University, Netherlands
Speaker
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