2019 APEC Harmonization Center Biotherapeutics Workshop Speaker List
- Jared Robert Auclair
Associate Teaching Professor and Director,
Chemistry and Chemical Biology,
Northeastern University -
- Day 1> Introductory
- APEC RHSC 2020 Vision and the Strategic Approaches
- Day 1> Session I
- Center of Excellence (CoE)
- Day 1> Session II (Chair)
- Other global outreach efforts
- Day 1> Introductory
- Yong Seok Ko
Senior Scientific Officer,
Drug Evaluation Department, Drug Review Management Division,
Ministry of Food and Drug Safety (MFDS) -
- Day 1> Introductory
- APEC Progress Towards Regulatory Convergence
- Day 1> Introductory
- Rominder Singh
Regional Head of Regulatory Affairs (Asia),
Global Regulatory Affairs,
Pfizer, Inc. -
- Day 1> Session I
- Overview and History of the Biotherapeutics Roadmap
- Day 2> Session IV (Moderator)
- Wrap up: Highlight of the workshop and next steps
- Day 1> Session I
- IlUng Oh
Senior Scientific Officer,
Biopharmaceuticals & Herbal Medicine Evaluation,
Ministry of Food and Drug Safety (MFDS) -
- Day 1> Session II
- WHO guideline of the Life Cycle Management for the Biologics
- Day 1> Session II
- Inhwa Choi
Director,
Market Access & Public Affairs,
Roche Korea -
- Day 1> Session II
- ICH guideline – Industry perspectives of how convergence and alignment to ICH guidelines has progressed in the past 10 years
- Day 1> Session II
- Ana Maria Agueda Chura Tito
Specialist,
Sanitary evaluation of pharmaceutical products,
DIGEMID -
- Day 1> Session II
- Impact on APEC regulatory system
- Day 1> Session II
- Seong Hwan Park
Senior Scientific Officer,
Biopharmaceutical Policy Division,
Ministry of Food and Drug Safety (MFDS) -
- Day 2> Session III Part A (Chair)
- Ong Mei Kuen
Senior Compliance Audit Manager,
External Relations APAC / Global Quality and Compliance,
Roche -
- Day 2> Session III Part A
- CMC & GMP Inspection - Industry Perspective: From CMC to GMP
- What Lies Ahead?
- CMC & GMP Inspection - Industry Perspective: From CMC to GMP
- Day 2> Session III Part A
- Ineui Lee
Project Professor,
Graduate School of Science, Technology and Innovation
Kobe University -
- Day 2> Session III Part A
- CMC & GMP Inspection - Academy (APEC CoE) Perspective
- Day 2> Session III Part A
- Phillip Nguyen
Director,
International Regulatory Policy & Program,
US Pharmacopeia -
- Day 2> Session III Part A
- Supply Chain
- Day 2> Session III Part A
- Jeewon Joung
Director,
Vaccine Division,
National Institute of Food and Drug Safety (NIFDS),
Ministry of Food and Drug Safety (MFDS) -
- Day 2> Session III Part A
- WHO
- Day 2> Session III Part A
- Sannie Chong
Head,
Roche -
- Day 2> Session III Part B (Chair)
- Tae Kyo Park
CEO/President
Management
IntoCell -
- Day 2> Session III Part B
- Antibody Drug Conjugate
- Day 2> Session III Part B
- Vikram Shina
Associate Vice President,
Quantitative Pharmacology and Pharmacometrics,
MSD -
- Day 2> Session III Part B
- Cancer metabolism drugs (targeting metabolism for cancer therapy)
- Day 2> Session III Part B
- Howard Lee
Professor,
Clinical Pharmacology and Therapeutics,
Seoul National University -
- Day 2> Session III Part B
- Precision Medicine
- Day 2> Session III Part B