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Hyatt Regency Bethesda

2017 年 10 月 24 日 7:00 上午 - 2017 年 10 月 25 日 3:30 下午

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

Biosimilars Conference

Session 8: Postmarketing Phase: Approval is Just the Beginning

Session Chair(s)

Charles  Barr, MD, MPH

Charles Barr, MD, MPH

Chief Medical Officer

Adaptic Health, United States

Approval of a biosimilar is just the beginning. This session will address postmarketing opportunities and challenges, postmarket safety monitoring and risk management, and areas where life-cycle management of biosimilars can differ from original biologics. Among the topics to be explored: What changes will be needed to meet the opportunity for interchangeability? What happens when changes are made to the reference biologic? How do the considerations for new indications, additional dosage forms, and presentations, PREA requirements, labeling maintenance, and manufacturing changes differ when your product is a biosimilar rather than an original biologic?

Learning Objective :
  • Identify approaches to meeting the opportunities and challenges at the postmarketing phase of a biosimilar
  • Compare and contrast the life cycle management of a biosimilar with that of an original biologic
  • Speaker(s)

    Carlos  Sattler, MD

    Speaker

    Carlos Sattler, MD

    Sandoz Inc. (a Novartis Company), United States

    VP, US Clinical Development and Medical Affairs

    Mark J Cziraky, PharmD

    Speaker

    Mark J Cziraky, PharmD

    Anthem HealthCore, United States

    Vice President of Research

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