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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
Senior Research Analyst
POLITICO's AgencyIQ, 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)
Speaker
Joel Welch, PhD
FDA, United States
Associate Director for Science and Biosimilar Strategy, OBP, OPQ, CDER
Speaker
Manuel Osorio, PhD
FDA, United States
Senior Scientist for Emerging Technologies, OD, CBER
Speaker
Ana Hidalgo-Simon, DrMed
European Medicines Agency, Netherlands
Head of Advanced Therapies