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Session 8: Fireside Chat: Regulatory Approaches to Emerging Technologies and Modalities Closing Remarks
Session Chair(s)
Judy Chou, PHD
President and CEO, AltruBio, Inc., United States
Kirsten Messmer, PHD, RAC
Owner, KM Intel LLC, United States
The Biotech Industry is evolving rapidly introducing novel technologies and/or treatment modalities at an ever-increasing speed. Understanding the national and global regulatory landscape is crucial to ascertain rapid patient access to reap the benefits globally. During this Fireside Chat global regulators will discuss current and future regulatory approaches as well as the agency’s expectations and requirements. The session will provide the opportunity to discuss regulatory questions with the participants from the regulatory agencies.
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)
Steven Oh, PHD
Acting Director, Division of Cell Therapy 1 & 2, FDA, United States
Speaker
Ana Hidalgo-Simon, DrMed
Associate Professor, Leiden University, Netherlands
Speaker
Omar Tounekti, PHD, MBA
Acting Director, Centre for Oncology, Radiopharmaceuticals and Research , Health Canada, Canada
Speaker
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