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Previous Workshops

Jane Bai

  • Jane Bai
  • CMC Advisor
  • GRA, Bayer Healthcare / IFPMA
    • Day 1 > Session 1 (Speaker)
      • Current Development/Regulatory Strategies of Biotherapeutic Products

Fia Ya-Ting Chen

  • Fia Ya-Ting Chen
  • Associate Technical Specialist
  • Division of Medicinal Products, Chinese Taipei Food and Drug Administration, Ministry of Health and Welfare
    • Day 2 > Session 2 (Speaker)
      • Output of the WHO Questionnaire [Chinese Taipei]

Freddy Faccin

  • Freddy Faccin
  • Regional Associate Medical Director - Biotherapeutics Global Medical Affair, AbbVie
    • Day 2 > Session 3 (Speaker)
      • Clinical data requirements for registration of biotherapeutics

Shalini Gupta

  • Shalini Gupta
  • Director Medical Sciences
  • Clinical Immunology, Medical Sciences, Amgen Inc.
    • Day 2 > Session 3 (Speaker)
      • The Importance of Immunogenicity Assessment of Therapeutic Proteins

Kowid Ho

  • Kowid Ho
  • Lead international policy
  • Pharma Technical Regulatory Policy, Roche
    • Day 2 > Session 4 (Speaker)
      • Review of key ICH Quality guidelines specific to Biologics (focus on Q5 series and Q6B) / Q5E for comparability or address this in more detail in the regulatory training session

David Hutto

  • David Hutto
  • Senior Director
  • Drug Safety, Eisai
    • Day 2 > Session 3 (Co-Chair / Speaker)
      • Non-clinical ICH S6 (Non-clinical evaluation of biotechnology products

Jeewon Joung

  • Jeewon Joung
  • Deputy Director
  • Recombinant Protein Products Division, Ministry of Food and Drug Safety
    • Day 1 > Session 2 (Co-Chair / Speaker)
      • Output of the WHO Questionnaire [Korea]

Yvonne Khoo

  • Yvonne Khoo
  • Evaluator
  • Biologics Product Registration Section, Malaysia National Pharmaceutical Control Bureau
    • Day 1 > Session 2 (Speaker)
      • Output of the WHO Questionnaire [Malaysia]

Byoung-guk Kim

  • Byoung-guk Kim
  • Senior Scientific Officer
  • Biopharmaceutical Policy Division, Korea Ministry of Food and Drug Safety
    • Day 1 > Session 1 (Speaker)
      • Overview of Biotherapeutic Roadmap

Yasuhiro Kishioka

  • Yasuhiro Kishioka
  • Reviewer
  • Pharmaceuticals and Medical Devices Agency
    • Day 1 > Session 2 (Speaker)
      • Output of the WHO Questionnaire [Japan]

Ivana Knezevic

  • Ivana Knezevic
  • Scientist
  • Essential Medicines and Health Products, WHO
    • Day 1 > Session 2 (Chair / Speaker)
      • Development and Implementation of WHO Guidelines for Regulatory Evaluation of Biotherapeutic Products

Lynne Krummen

  • Lynne Krummen
  • Vice President
  • Technical Regulatory, Roche Pharmaceuticals
    • Day 2 > Session 4 (Speaker)
      • Feasibility of application of ICH Q8-11 to Biotherapeutic products (Industry presenting case study)

Hyuk Jae Lee

  • Hyuk Jae Lee
  • Department Head
  • Department of Regulatory Affairs & Clinical Operation, Celltrion, Inc
    • Day 1 > Session 1 (Speaker)
      • Progress and Update on Biosimilars Development in Korea

Chung Keel Lee

  • Chung Keel Lee
  • Special Advisor to the Minister
  • Korea Ministry of Food and Drug Safety
    • Day 2 > Session 4 (Chair / Speaker)
      • GMP highlights in Biopharmaceuticals

Richard Lit

  • Richard Lit
  • Vice-President
  • Global Regulatory Affairs, CMC, Biosimilars, Devices, Amgen
    • Day 2 > Session 4 (Speaker)
      • LifeCycle Management for Biotherapeutics : The Complex world of post-approval changes--Industry presenting case study

Judith Macdonald

  • Judith Macdonald
  • Senior Director, Global regulatory affairs cross asset lead
  • Pfizer biosimilars, Worldwide regulatory, Pfizer
    • Day 1 > Session 1 (Speaker)
      • Biosimilar Regulatory Frameworks with Room for Convergence, What more is needed?

James Merson

  • James Merson
  • CSO
  • Vaccine Immunotherapeutics Research Unit, Pfizer
    • Day 2 > Plenary Lecture : High-level overview of new innovative technologies in biotherapeutics

Wassim Nashabeh

  • Wassim Nashabeh
  • Global Head
  • Technical (CMC) Regulatory Policy, Genentech
    • Day 2 > Session 4 (Coordinator / Co-Chair)

Romi Singh

  • Romi Singh
  • Executive Director
  • Global Regulatory Affairs & Safety, Amgen Inc.
    • Day 1 >Session 2 (Coordinator)

Yeowon Sohn

  • Yeowon Sohn
  • Director General
  • Biopharmaceuticals and Herbal medicine Evaluation Department, National Institute of Food and Drug Safety Evaluatioin, Korea Ministry of Food and Drug Safety
    • Day 1 > Session 1 (Chair)

Jerry Stewart

  • Jerry Stewart
  • Regulatory Policy Head, Emerging Markets
  • Worldwide Regulatory Affairs, Pfizer
    • Day 1 > Session 1 (Coordinator / Co-Chair / Speaker)
      • AHC 2012 Biosimilars Workshop Output

Prapassorn Thanaphollert

  • Prapassorn Thanaphollert
  • Head / Assistant Director
  • Food and Drug Administration, Pre-marketing Control Division / Bureau of Drug Control Thailand Ministry of Public Health
    • Day 1 > Session 2 (Speaker)
      • Output of the WHO Questionnaire [Thailand]

Jian Wang

  • Jian Wang
  • Chief
  • Clinical Evaluation Division - Biologics and Genetic Therapies Directorate, Health Canada
    • Day 1 > Session 2 (Speaker)
      • Clinical Experts from WHO Drafting Group - Key Issues that Regulators should Consider While Reviewing CT Data
    • Day 2 > Session 3 (Chair)

AHC Noimage

  • Mike Ward
  • Health Canada
    • Day 1 > Session 2 (Speaker)
      • ICH Current Status and APEC Regional Harmonization Efforts

Mats Welin

  • Mats Welin
  • Senior expert
  • Division of pharmaceuticals and biotechnology, Medical Products Agency
    • Day 2 > Session 4 (Speaker)
      • Review of recent ICH Quality guideline focused on enhanced process/product understanding (ICH Q8-11)

Kum Cheun Wong

  • Kum Cheun Wong
  • Head
  • Asia Pacific Policy & Liaison, Drug Regulatory Affairs, Novartis Asia Pacific Pharmaceuticals Pte Ltd
    • Day 1 > Session 1 (Speaker)
      • Biologics vs. Small Molecule Pharmaceuticals

Teruhide Yamaguchi

  • Teruhide Yamaguchi
  • Technical Expert
  • Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency
    • Day 2 > Plenary Lecture (Moderator)