返回 Agendas
Session 1A: CMC Track: CMC Opportunities and Challenges in Asia
Session Chair(s)
Helen Wood
Scientific Investigator
GSK, United Kingdom
The goal of this session is to discuss CMC opportunities and challenges in Asia. The first presenter will discuss regulatory considerations for oligonucleotide-based drugs in Japan from the perspective of the PMDA. The focus of the second presentation is regulatory considerations for therapeutics in China. The session concludes with a panel discussion; potential discussion topics include:
• JP compliance
• Analytical method validation and system suitability requirements
• Foreign manufacturers accreditation, memorandum of understanding and in-country testing requirements
Speaker(s)
Discussion on Regulatory Consideration of Oligonucleotide-based Drugs in Japan
Kosuke Ito, PHD
Osaka University, Graduate School of Pharmaceutical Sciences, Japan
Specially Appointed Assistant Professor, Drug Innovation Center
CASE STUDY: IND filing to CFDA for Cotsiranib® (STP705), a New Anti-fibrosis siRNA Therapeutic Product
Marc M. Lemaitre, DRSC
ML_Consult, United States
Consultant
Manufacturing Therapeutic Oligonucleotides in China: Particularities and Current Status
Dmitry Samarsky, PHD
RiboBio, China
Senior Vice President, Internatinal Business & Technology
Q&A Panel Discussion (Joining the Speakers):
René Thürmer, PHD
Federal Institute for Drugs and Medical Devices, Germany
Quality Assessor