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DoubleTree Bethesdan

Sep 23, 2019 7:00 AM - Sep 24, 2019 5:00 PM

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

Biosimilars Conference

Session 10: Regulatory Developments/Ask the Regulator

Session Chair(s)

Sarah  Yim, MD

Sarah Yim, MD

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


Elena  Wolff-Holz, MD, PhD

The Regulatory Situation of Biosimilars in the EU

Elena Wolff-Holz, MD, PhD

Paul-Ehrlich Institut, Germany

Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor

Emily  Griffiths, PhD


Emily Griffiths, PhD

Health Canada, Canada

Subject Matter/Technical Specialist

Guido  Pante, PhD


Guido Pante, PhD

World Health Organization , Switzerland

Technical Officer

Sarah  Yim, MD


Sarah Yim, MD

FDA, United States

Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER

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