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Facilitated Regulatory Pathways

APEC Virtual Workshop on Facilitated Regulatory Pathways

 

  • John Lim
    Executive Driector,
    Center for Regulatory Excellence (CoRE),
    Duke-National University of Singapore
    • Day 1> Introduction & Setting the Scene

 

  • Lawrence Liberti
    Head,
    Regulatory Collaborations,
    US Food and Drug Administration (US FDA)
    • Day 1> How APEC Regulatory Authorities Can Enable, Design, and Implement FRPs
    • Day 2> Looking Beyond Regulatory Approval to reimbursement Decisions and Patient Access

 

  • Paris Watson
    Health Science Policy Analyst,
    US Food and Drug Administration (US FDA)
    • Day 1> Diving Deep on FRP Acceptance Criteria

 

  • Xiaoying Zheng
    Dean,
    Faculty of Business & Law,
    Peking University-APEC Health Sciences Academy
    • Day 1> Diving Deep on FRP Acceptance Criteria
      • Policy Development and Updates on China Rare Disease

 

  • Keith Wonnacott
    Executive Director,
    Regulatory Affairs, Gene & Cell-Based Therapies,
    Pfizer
    • Day 1> Diving Deep on FRP Acceptance Criteria
      • Accelerated Development and Registration for Innovative Products: Gene Therapy Examples

 

  • Worasuda Yoongthong
    Acting Director,
    Division of Innovative Health Products & Services,
    Thailand Food and Drug Administration (Thai FDA)
    • Day 1> Diving Deep on FRP Review Process
      • Sharing Experience on Facilitated Regulatory Pathway Review Process

 

  • Durhane Wong-Reiger
    Chair,
    Rare Disease International
    • Day 1> Diving Deep on FRP Review Process
      • Patient Engagement in Facilitated Regulatory Pathways for Orphan Drugs

 

  • Irene Deng
    Head,
    Regulatory Affairs,
    Sanofi
    • Day 1> Diving Deep on FRP Review Process
      • Facilitated Regulatory Pathways in China

 

  • John Skerritt
    Deputy Secretary,
    Health Product Regulation,
    Department of Health, Australia
    • Day 2> Special Session: Role of Reliance in Expedited Approvals of Innovative Products
      • Role of reliance in expedited approvals of Innovative products: the ACSS experience

 

  • Rosilawati Ahmad
    Deputy Director,
    National Pharmaceutical Regulatory Agency (NPRA), Malaysia
    • Day 2> Special Session: Role of Reliance in Expedited Approvals of Innovative Products

 

  • Paul Dearden
    Senior Director,
    Global Regulatory Policy,
    Biogen
    • Day 2> Special Session: Role of Reliance in Expedited Approvals of Innovative Products

 

  • Yonglin Jiang
    Program Manager,
    Center for Drug Evaluation,
    National Medical Products Administration (NMPA), China
    • Day 2> Diving Deep on FRP Decision Criteria & Post-Authorization Activities
      • Rare Diseases: Drug Review and Registration Regulations

 

  • James Leong
    Assistant Professor & Head,
    Pharmaceutical Regulatory Science Programme,
    Centre of Regulatory Excellence (CoRE),
    Duke-National University of Singapore
    • Day 2> Diving Deep on FRP Decision Criteria & Post-Authorization Activities

Janet Lu

  • Janet Lu
    Head,
    Regulatory,
    Roche
    • Day 2> Diving Deep on FRP Decision Criteria & Post-Authorization Activities
      • Rare Disease Drugs, Post-Approval Activities in China

 

  • Mario Alanis
    Senior Advisor,
    Centre for Innovation in Regulatory Science (CIRS)
    • Day 2> Preparing for the Next Public Health Emergency
      • Emergency Use Pathways (EUPs) to facilitating treatment & vaccines for COVID-19

Maria Cristina Mota

  • Maria Cristina Mota
    Director,
    Regulatory Policy & Intelligence, Japan, Emerging Markets and Australia,
    AbbVie
    • Day 2> Preparing for the Next Public Health Emergency
      • Regulatory Preparedness for Public Health Emergencies

 

  • Nobumasa Nakashima
    Associate Executive Director,
    International Programs and Asia Training Centre,
    Pharmaceuticals and Medical Devices Agency (PMDA)
    • Day 2> Preparing for the Next Public Health Emergency

 

  • Brian O’Rourke
    Former CEO,
    Canadian Agency for Drugs & Technologies in Health (CADTH)
    • Day 2> Looking Beyond Regulatory Approval to Reimbursement Decisions and Patient Access
      • Looking Beyond Regulatory Approval

 

  • Heidi Wang
    Vice President,
    Head of Oncology Global Regulatory Strategy and Policy,
    Bristol-Myers Squibb (BMS)
    • Day 2> Looking Beyond Regulatory Approval to Reimbursement Decisions and Patient Access
      • The Path from Development to Regulatory Approval to Patient Access