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Session 2A: Control Strategy for Double-Stranded Oligonucleotides
Session Chair(s)
Samantha Gao-Sheridan, PhD
Senior Director, Regulatory Affairs CMC
Alnylam Pharmaceuticals, United States
Learning Objective :
Speaker(s)
European Regulatory Perspective on Double-Stranded Oligonucleotides
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
Characterization and Control of siRNA Impurities
Matthias Kretschmer, PhD
Alnylam Pharmaceuticals, United States
Senior Director, Analytical Development
Panel Discussion
All Session Speakers, United States
Panelist
Ramesh Raghavachari, PhD
FDA, United States
Chief, Branch I, DPMA1, OLDP, OPQ, CDER
Panelist
Vidhya Gopalakrishnan, PhD
Quark Pharmaceuticals, Inc, United States
Senior Vice President, Pharmaceutical Development