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Good Registration Management

Good Registration Management



Common Session

Li-Ling Liu 

  • Li-Ling LiuDirector
    Office of International Pharmaceutical Affairs,
    Taiwan FDA
    • Day 1 ▶Session I (Chair)
      • The APEC 2020 Roadmap to promote GRM and the Curriculum design of this Pilot Workshop

Isao Sasaki 

  • Isao SasakiMember
    JPMA
    • Day 1 ▶ Session 1
      • Background of GRM and high level principles and processes of GRevP & GSubP
    • Day 1 ▶ Session 3 (Chair)
      • An Overview of Good Submission
    • Day 3 ▶ Session R6/A5
      • Panel Discussion

Prisha Patel 

  • Prisha PatelManager
    Emerging Markets Programmes,
    CIRS
    • Day 1 ▶ Session 1
      • How to build quality onto the regulatory submission and review process and how can these be measured

Florence Houn 

  • Florence HounVice President,
    Global Regulatory Science,
    Celgene Corporation
    • Day 1 ▶ Session 2 (Chair)
      • WHO Good Review Practices Guidelines for Regulatory Authorities

Mark Goldberger 

  • Mark GoldbergerMember
    FDAAA
    • Day 1 ▶ Session 2
      • The Challenge of Making Good Review Practices a Reality

Jing Zhang 

  • Jing ZhangMedical Doctor,
    Neuroscience,
    Janssen
    • Day 1 ▶ Session 2
      • Management of the Review and Quality System in US FDA

Kanako Takatsuki 

  • Kanako TakatsukiPrincipal Planning and Coordination Officer,
    Office of International Cooperation,
    PMDA
    • Day 1 ▶ Session 4 (Chair)
    • Day 3 ▶ Session A5/R6
      • Panel Discussion

Eriko Yamazaki 

  • Eriko YamazakiReviewer
    Office of New Drug I,
    PMDA
    • Day 1 ▶ Session 4
      • Case study: Effective Communication for GRM

Diana Ryder Kaminsky 

  • Diana Ryder KaminskyVice President,
    Strategy and Market Development,
    RAPS
    • Day 3 ▶ Session A5/R6
      • RAPS Regulatory Competency Framework
      • Panel Discussion

Silke Vogel 

  • Silke VogelDeputy Director,
    CoRE
    • Day 3 ▶ Session A5/R6 (Chair)
      • Competency gaps identified in Asia
      • Panel Discussion

Jinjie Hu 

  • Jinjie HuSenior Consultant,
    Biologics Consulting Group
    • Day 3 ▶ Session A5/R6
      • Panel Discussion

Chao-Yi Wang 

  • Chao-Yi WangDirector
    Division of Medicinal Products,
    Taiwan FDA
    • Day 3 ▶ Session A5/R6
      • Panel Discussion

Churn-Shiouh Gau 

  • Churn-Shiouh GauChief Executive Director,
    CDE
    • Day 3 ▶ Session A5/R6
      • Panel Discussion

Lahouari Belgharbi 

  • Lahouari BelgharbiDirector General,
    Center of Excellence,
    COFEPRIS
    • Day 3 ▶ Session A5/R6
      • Panel Discussion

Sannie S.F. Chong 

  • Sannie S.F. ChongHead
    APAC Technical Regulatory Policy,
    Roche
    • Day 3 ▶ Session A5/R6
      • Panel Discussion

Christine Kuang 

  • Christine KuangRA Taskforce Leader, Head
    Drug Regulatory Affairs,
    Boehringer Ingelheim
    • Day 3 ▶ Session A5/R6
      • Panel Discussion


Applicant-Specific Session

Jin Shun 

  • Jin ShunDirector,
    Regulatory Policy and Intelligence,
    AbbVie Pte. Ltd.
    • Day 2 ▶ Session A1
      • What do we want
      • Q&A
      • Case Studies

Thean Soo Lo 

  • Thean Soo LoDirector,
    Asia Pacific Regulatory Policy&Intelligence,
    Global Regulatory Affairs,
    J&J
    • Day 2 ▶ Session A1
      • What do we need
      • Q & A
      • Case Studies

Sannie S.F. Chong 

  • Sannie S.F. ChongHead
    APAC Technical Regulatory Policy,
    Roche
    • Day 2 ▶ Session A1
      • What do we need
      • Q & A
      • Case Studies

Shinji Hatakeyama 

  • Shinji HatakeyamaDirector,
    Asia Regulatory Affairs,
    Japan/Asia Regulatory & Asia Clinical Operations Department,
    Eisai
    • Day 2 ▶ Session A2
      • Introduction / Ice-Breaking game
      • Dossier Preparation
      • Practice 1
      • Practice 2
      • Wrap up

Mari Toji 

  • Mari TojiSpecialist,
    Regulatory Affairs Department,
    Chugai Pharmaceutical
    • Day 2 ▶ Session A2
      • Practice 1
      • Practice 2

Naoko Matsui 

  • Naoko MatsuiManager,
    Asia Development Department,
    Daiichi Sankyo
    • Day 2 ▶ Session A2
      • SOP

Maya Kumano 

  • Maya KumanoManager,
    Global Regulatory Affairs Department,
    Shionogi & Co
    • Day 3 ▶ Session A3 (Chair)
      • Introduction / Ice-Breaking game
      • GRP Communication introduction

Kenichi Otani 

  • Kenichi OtaniDirector,
    Development Regulatory Affairs Group,
    Drug Development Division,
    Sumitomo Dainippon Pharma Co.
    • Day 3 ▶ Session A3
      • Group Discussion
      • Lecture 1: Effective Communication 1

Akiko Ikeda 

  • Akiko IkedaSenior Manager,
    Policy Intelligence Department,
    Janssen Pharma K.K
    • Day 3 ▶ Session A3
      • Group Discussion
      • Lecture 2: Effective Communication 2

Isao Sasaki 

  • Isao SasakiMember
    JPMA
    • Day 3 ▶ Session A4 (Chair)
      • Trainer’s Manual on GSubP

Silke Vogel 

  • Silke VogelDeputy Director,
    CoRE
    • Day 3 ▶ Session A4
      • Facilitating team-based learning

James Leong 

  • James LeongHead of Education,
    CoRE
    • Day 3 ▶ Session A4
      • Facilitating team-based learning


Reviewer-Specific Session

Chao-Yi Wang 

  • Chao-Yi WangDirector
    Division of Medicinal Products,
    Taiwan FDA
    • Day 2 ▶ Session R1 (Chair)
      • Session Purpose and Objective
      • Introductory icebreakers
      • Group Discussion

Hsien-Yi Lin 

  • Hsien-Yi LinSenior Reviewer,
    Division of Medicinal Products,
    Taiwan FDA
    • Day 2 ▶ Session R1
      • An Introductory Overview of Managing the review Based on the WHO Good Review Practice Guidelines for Regulatory Authorities
      • Group Discussion

Jing Zhang 

  • Jing ZhangMedical Doctor,
    Neuroscience,
    Janssen
    • Day 2 ▶ Session R1
      • Experience Sharing from Different Regulatory Authorities
      • Group Discussion
    • Day 3 ▶ Session R3 (Chair)
      • Critical Thinking in Clinical Review
      • Panel Discussion

Kanako Takatsuki 

  • Kanako TakatsukiPrincipal Planning and Coordination Officer,
    Office of International Cooperation,
    PMDA
    • Day 2 ▶ Session R1
      • - Experience Sharing from Different Regulatory Authorities
    • Day 2 ▶ Session R2
      • Practices in Japan

Tai Hsin Ou 

  • Tai Hsin OuProject Manager,
    Division of Regulatory Affairs and Compliance,
    CDE
    • Day 2 ▶ Session R1
      • Experience Sharing from Different Regulatory Authorities
      • Group Discussion

Yu-Ting Chiu 

  • Yu-Ting ChiuProject Manager,
    Division of Regulatory Affairs and Compliance,
    CDE
    • Day 2 ▶ Session R1
      • Group Discussion

Min Chen 

  • Min ChenSenior Science Advisor,
    Taiwan FDA
    • Day 2 ▶ Session R2 (Chair)
      • Overview and Fundamentals

Florence Houn 

  • Florence HounVice President,
    Global Regulatory Science,
    Celgene Corporation
    • Day 2 ▶ Session R2
      • Case Studies
    • Day 3 ▶ Session R3
      • Panel Discussion

Yen-Wen Chen 

  • Yen-Wen ChenTeam Leader,
    Center of Consultation,
    CDE
    • Day 3 ▶ Session R3
      • Critical thinking and regulatory decision making: clinical reviewer’s perspectives
      • Panel Discussion

Mark Goldberger 

  • Mark GoldbergerMember
    FDAAA
    • Day 3 ▶ Session R3
      • Panel Discussion

Junko Sato 

  • Junko SatoDirector,
    Office of International Cooperation,
    PMDA
    • Day 3 ▶ Session R4 (Chair)
      • Conducting the Review

Yi-Lin Wang 

  • Yi-Lin WangTeam Leader,
    Division of Pharmaceutical Science,
    CDE
    • Day 3 ▶ Session R4
      • Conducting the review from pharmacokinetic reviewer’s perspective

Jinjie Hu 

  • Jinjie HuSenior Consultant,
    Biologics Consulting Groups, Inc.
    • Day 3 ▶ Session R5 (Chair)
      • Introductory of Reviewer’s Trainer’s Manual
      • Build Good Review Practice into the Training Program

David T. Lin 

  • David T. LinSenior Consultant,
    Biologics Consulting Groups, Inc.
    • Day 3 ▶ Session R5
      • Training Curriculum Development
      • Training Material Organization