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Biotherapeutics

 

2019 APEC Harmonization Center Biotherapeutics Workshop Speaker List

 

Jared Robert Auclair

  • 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

Yong Seok Ko

  • 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

Rominder Singh

  • 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

IlUng Oh

  • 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

Inhwa Choi

  • 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

Ana Maria Agueda Chura Tito

  • Ana Maria Agueda Chura Tito
    Specialist,
    Sanitary evaluation of pharmaceutical products,
    DIGEMID
    • Day 1> Session II
      • Impact on APEC regulatory system

Seong Hwan Park

  • 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

  • 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?

Ineui Lee

  • 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

Phillip Nguyen

  • Phillip Nguyen
    Director,
    International Regulatory Policy & Program,
    US Pharmacopeia
    • Day 2> Session III Part A
      • Supply Chain

Jeewon Joung

  • 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

Sannie Chong

  • Sannie Chong
    Head,
    Roche
    • Day 2> Session III Part B (Chair)

Tae Kyo Park

  • Tae Kyo Park
    CEO/President
    Management
    IntoCell
    • Day 2> Session III Part B
      • Antibody Drug Conjugate

Vikram Shina

  • Vikram Shina
    Associate Vice President,
    Quantitative Pharmacology and Pharmacometrics,
    MSD
    • Day 2> Session III Part B
      • Cancer metabolism drugs (targeting metabolism for cancer therapy)

Howard Lee

  • Howard Lee
    Professor,
    Clinical Pharmacology and Therapeutics,
    Seoul National University
    • Day 2> Session III Part B
      • Precision Medicine