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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 3: Impact of US FDA Final Naming Guidance for Biologics

Session Chair(s)

Hillel P Cohen, PhD

Hillel P Cohen, PhD

Executive Director, Scientific Affairs

Sandoz Inc., United States

In January 2017, the FDA issued a Final Guidance on the naming of biologics, including originator biologic medicines and biosimilars. The FDA is developing plans to roll out this new naming convention both prospectively and retrospectively. Likewise, numerous stakeholders throughout the US health care system have already or will adapt their current processes to accommodate the Final Guidance. This session will explore considerations for implementing the new system and provide an overview of some of these plans.

Learning Objective :
  • Discuss the impact of the Final Naming Guidance on manufacturers, supply chain, end users, and safety systems
  • Identify some of the steps that will be undertaken by stakeholders to ensure adherence with the Final Guidance
  • Assess how these changes may impact the participant
  • Speaker(s)

    Kellie  Taylor

    Speaker

    Kellie Taylor

    FDA, United States

    Associate Director, OMEPRM, OSE, CDER, FDA

    Thomas  Felix, MD

    Speaker

    Thomas Felix, MD

    Amgen Inc., United States

    Medical Director, R&D Policy, Global Regulatory Affairs and Safety

    Tammy P Powell, MLIS, MS

    Speaker

    Tammy P Powell, MLIS, MS

    National Library of Medicine, United States

    Health Program Specialist

    Gerald  McEvoy, PharmD

    Speaker

    Gerald McEvoy, PharmD

    American Society of Health-System Pharmacists, United States

    Assistant Vice President of Drug Information

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