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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, DrMed
Principal Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
The Ongoing Revision of ICH Q9 on Quality Risk Management and PQS Effectiveness Considerations
Kevin O’Donnell
Market Compliance Manager and Senior Inspector, Health Products Regulatory Authority, Ireland
New Challenges on Quality Control upon High-Tec
Hyang Won Min, MSc, RPh
Vice President, Head of APAC Regulatory Affairs, Johnson & Johnson, Singapore
Regulatory Perspective on Managing Nitrosamine Impurities –MFDS
Jaehyun Park
Senior Reviewer of Pharmaceutical Standardization Division, , Drug Evaluation Department, NIFDS, MFDS, Korea, Republic of
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