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DoubleTree Bethesdan

2019 年 09 月 23 日 7:00 上午 - 2019 年 09 月 24 日 5:00 下午

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

Biosimilars Conference

Session 8: Streamlining and Harmonizing Biosimilar Development

Session Chair(s)

Christopher J. Webster, DVM, PhD, MS, MSc

Christopher J. Webster, DVM, PhD, MS, MSc

Principal

BioApprovals, United States

Vast experience has been gained in the development of biosimilars over the past decade, which can enable the streamlining of biosimilar developments by allowing specific reductions of regulatory requirements without compromising the quality or safety of the product. Moreover, there is a broad interest of patients that such opportunities are pursued vigorously, as the elimination of unnecessary regulatory requirements contributes to competition within the biosimilars’ market and the eventual affordability of, and access to, biosimilars. This session will examine new proposals for streamlining the development of biosimilars and consider the circumstances under which such new approaches might be introduced and the issues to be confronted in harmonizing these approaches across the world.

Learning Objective : Upon completion of this session, the participant should be able to:
  • Be aware of potential new directions for the evolution of regulatory requirements for the development of biosimilars and the scientific bases for them
  • Understand how such new regulatory requirements might be introduced into current development paradigms
  • Be able to design efficient global development plans for biosimilars taking advantage of new regulatory approaches

Speaker(s)

Christopher J. Webster, DVM, PhD, MS, MSc

Efficient Development of Biosimilars: A Rumsfeldian Approach

Christopher J. Webster, DVM, PhD, MS, MSc

BioApprovals, United States

Principal

Martin  Schiestl, PhD

Tailored Clinical Biosimilar Development

Martin Schiestl, PhD

Sandoz GmbH, Austria

Global Head Regulatory Affairs Policy

Guido  Pante, PhD

Update on the WHO Pilot Procedure for Prequalification of BTPs: Rituximab and Trastuzumab

Guido Pante, PhD

World Health Organization , Switzerland

Technical Officer

Guido  Pante, PhD

Panel Discussion: Streamlining Global Biosimilar Development

Guido Pante, PhD

World Health Organization , Switzerland

Technical Officer

Martin  Schiestl, PhD

Panel Discussion: Streamlining Global Biosimilar Development

Martin Schiestl, PhD

Sandoz GmbH, Austria

Global Head Regulatory Affairs Policy

Christopher J. Webster, DVM, PhD, MS, MSc

Panel Discussion: Streamlining Global Biosimilar Development

Christopher J. Webster, DVM, PhD, MS, MSc

BioApprovals, United States

Principal

Elena  Wolff-Holz, MD, PhD

Panel Discussion: Streamlining Global Biosimilar Development

Elena Wolff-Holz, MD, PhD

Paul-Ehrlich Institut, Germany

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

Sarah  Yim, MD

Panel Discussion: Streamlining Global Biosimilar Development

Sarah Yim, MD

FDA, United States

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

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