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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

  • Executive Director, Scientific Affairs
  • Sandoz Inc., United States
Jian  Wang, MD, PhD

Speaker

Jian Wang, MD, PhD

  • Division Manager, Clinical Review Division – Heamatology/Oncology
  • Health Canada, Canada
Andrea  Laslop, MD

Speaker

Andrea Laslop, MD

  • Head of Scientific Office
  • Austrian Medicines and Medical Devices Agency, Austria
Eva  Temkin, JD

Speaker

Eva Temkin, JD

  • Partner, FDA and Life Sciences
  • King & Spalding LLP, United States
Stacey  Ricci, DrSc

Speaker

Stacey Ricci, DrSc

  • Director, Scientific Review Staff, OTBB, OND, CDER
  • FDA, United States