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Hyatt Regency Bethesda

24 oct 2017 7:00 a.m. - 25 oct 2017 3:30 p.m.

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Biosimilars Conference

Session 6: Taking the International Pulse: What’s New in the Policy and Regulatory Landscape?

Session Chair(s)

Suzette  Kox, MPharm

Suzette Kox, MPharm

Senior Director International-Biosimilars Medicines Group

Medicines for Europe, Belgium

In this session, international regulators from the European Union, Japan, Canada, and the World Health Organization will provide an overview of recent and future policy and regulatory developments in their country/region in the field of biosimilar medicines. An update on lessons learned over the years of existence of the biosimilar pathway will set the scene for what’s coming next and how experience will be factored in regulatory science to shape future evolutions in the biosimilar medicines field in terms of local/regional guidance and its implementation. The impact of international information exchange and collaboration platforms (bilateral and multi-lateral) will also be examined.

Learning Objective :
  • Describe recent and upcoming policy and regulatory developments in significant regulatory jurisdictions
  • Integrate regulators recommendations and clarifications into regulatory operations
  • Analyze how developments may impact your activities (mitigation of threats, identification of opportunities)
  • Speaker(s)

    Ivana  Knezevic

    Speaker

    Ivana Knezevic

    World Health Organization, Switzerland

    Technical Standards and Specifications Unit (TSS)

    Cathy A. Parker

    Speaker

    Cathy A. Parker

    Health Canada, Canada

    Director General, Biologics & Genetic Therapies Directorate HPFB

    Kyoko  Sakurai, PharmD

    Speaker

    Kyoko Sakurai, PharmD

    Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Reviewer, Office of Cellular and Tissue-Based Products

    Leon van Aerts, PhD

    Speaker

    Leon van Aerts, PhD

    Medicines Evaluation Board, The Netherlands, Netherlands

    Leah  Christl, PhD

    Speaker

    Leah Christl, PhD

    Amgen, United States

    Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy

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