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Virtual Event

Oct 06, 2020 10:00 AM - Oct 07, 2020 5:25 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

Biosimilars Conference

Session 9: Regulatory Landscape – Ask the Regulators and Closing Remarks

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 question and answer 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
  • Better interpret the regulatory perspective on biosimilar-related development in the participating countries
  • Better answer biosimilar-related development questions from a regulatory perspective

Speaker(s)

Hillel P Cohen, PhD

Closing Remarks

Hillel P Cohen, PhD

Sandoz Inc., United States

Executive Director, Scientific Affairs

Jian  Wang, MD, PhD

Speaker

Jian Wang, MD, PhD

Health Canada, Canada

Division Manager, Clinical Review Division – Heamatology/Oncology

Andrea  Laslop, MD

Speaker

Andrea Laslop, MD

Austrian Medicines and Medical Devices Agency, Austria

Head of Scientific Office

Eva  Temkin, JD

Speaker

Eva Temkin, JD

King & Spalding LLP, United States

Partner, FDA and Life Sciences

Stacey  Ricci, DrSc

Speaker

Stacey Ricci, DrSc

FDA, United States

Director, Scientific Review Staff, OTBB, OND, CDER

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