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Session 1: Quality Control Through Technological Advancement
Session Chair(s)
Mijeong Kim
Director- Pharmaceutical Standardization Division, NIFDS
MFDS, Korea, Republic of
The new paradigm of quality in the biopharma will be updated on the evolving regulatory landscape and innovative manufacturing technology. In this session, we will discuss scientific risk-based quality management which is enabled by advanced manufacturing technology, digital technology, and a stable supply chain after the pandemic followed by management strategies for genotoxic impurities.
Speaker(s)
Development of Continuous Manufacturing Process(Q13)
Yoshihiro Matsuda, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist (for Quality), Pharmacist
The Ongoing Revision of ICH Q9 on Quality Risk Management and PQS Effectiveness Considerations
Kevin O’Donnell
Health Products Regulatory Authority, Ireland
Market Compliance Manager and Senior Inspector
New Challenges on Quality Control upon High-Tec
Hyang Won Min, MSc, RPh
Johnson & Johnson, Singapore
Vice President, Head of APAC Regulatory Affairs
Regulatory Perspective on Managing Nitrosamine Impurities –MFDS
Jaehyun Park
Drug Evaluation Department, NIFDS, MFDS, Korea, Republic of
Senior Reviewer of Pharmaceutical Standardization Division,