Menu Back toSession-10-Regulatory-Developments-Ask-the-Regulator

Biosimilars Conference


Session 10: Regulatory Developments/Ask the Regulator

Session Chair(s)

Sarah  Yim, MD

Sarah Yim, MD

  • Acting Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
  • FDA, United States
This session focuses on the regulator’s perspective and provides an opportunity for interactive Q&A. The session will begin with brief presentations of the highlights of recent regulatory developments from the mentioned regulators, followed by a panel Q&A session.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe recent biosimilar-related regulatory developments in the participating speakers’ countries
  • Interpret the regulatory perspective on biosimilar-related development in the participating countries
  • Understand biosimilar-related development questions from a regulatory perspective

Speaker(s)

Elena  Wolff-Holz, MD, PhD

The Regulatory Situation of Biosimilars in the EU

Elena Wolff-Holz, MD, PhD

  • Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP
  • European Medicines Agency, Netherlands
Emily  Griffiths, PhD

Speaker

Emily Griffiths, PhD

  • Subject Matter/Technical Specialist
  • Health Canada, Canada
Guido  Pante, PhD

Speaker

Guido Pante, PhD

  • Technical Officer
  • World Health Organization , Switzerland
Sarah  Yim, MD

Speaker

Sarah Yim, MD

  • Acting Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
  • FDA, United States

Contact us

Registration Questions?

Send Email
1.888.257.6457


Check out our 2019 Program!