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Session 3 Track 3: Emerging Oligonucleotide CMC Guidance
Session Chair(s)
Benjamin Stevens, PhD, MPH
Director CMC Policy and Advocacy
GlaxoSmithKline, United States
Representative Invited
FDA, United States
This session will provide updates on emerging regulatory guidances from key global regulators such as FDA and EMA. Special emphasis will be placed on the forthcoming EMA guidance on synthetic oligonucleotides given the 2023 publication of the concept paper and feedback from industry. A panel discussion including both regulator and industry perspectives will follow to address audience questions and any future directions that will impact the global regulatory landscape for oligonucleotides.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify key emerging global oligonucleotide guidance
- Apply concepts from the session to establishing regulatory strategies for meeting the requirements of global regulators for oligonucleotides
- Analyze and discuss new or evolving elements of the emerging regulatory landscape for oligonucleotides, particularly potential risks or gaps
Speaker(s)
Speaker
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
Speaker
Katherine Windsor, PhD
Food and Drug Administration, United States
Senior Pharmaceutical Quality Assessor, CDER
Speaker
Representative Invited
United States Pharmacopei, United States
Speaker
Representative Invited
Eli Lilly & Company, United States
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