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De Vere Venues

Nov 04, 2015 7:00 AM - Nov 05, 2015 5:00 PM

1 Westferry Circus, Canary Wharf, London, E14 4HA, United Kingdom

Biosimilars Conference 2015

This conference discusses biosimilars in the EU and internationally, with a focus on both regulatory and scientific challenges as well as market access and experiences.

Overview

This 2-day conference is the third of its kind. It will provide an update on the current status for biosimilars in EU and internationally with focus on both regulatory and scientific challenges as well as market access and experiences. Patients' and physicians' approach to use of biosimilars will be part of the scope including a discussion on biosimilars adoption into current treatment guidelines in EU. The conference will consist of plenary lectures followed by interactive panel discussions providing participants an opportunity to bring forward their own experience and share their thoughts and ideas with the experts.

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Featured topics

  • Current regulatory status of biosimilars in the EU
  • International development of biosimilars
  • Naming of biologicals including biosimilars
  • Pharmacovigilance issues related to biosimilars – EU and globally
  • Market experience with biosimilars including market access and pricing Patient and physicians approach to use of biosimilars

Featured

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Continuing-Education

Who should attend?

This conference is aimed at intermediate and experienced professionals from:

  • Regulatory agencies
  • The pharmaceutical industry and service providers including
    • Regulatory affairs personnel
    • Pharmacovigilance staff
    • Clinical and medical personnel
  • Academic institutions
  • Physicians and their scientific societies
  • Patients organisations

Learning objectives

  • Deal with regulatory requirements, scientific and operational challenges
  • Exchange experiences and discuss Hot Topics with experts
  • Update the participant on the current knowledge including regulatory and scientific thinking
  • Discuss pros and cons of Biosimilars

Program Committee

  • Steffen  Thirstrup, MD, PhD
    Steffen Thirstrup, MD, PhD Chief Medical Officer
    European Medicines Agency, Netherlands
  • Sabine  Atzor, MPharm, RPh
    Sabine Atzor, MPharm, RPh Head of EU Regulatory Policies
    F. Hoffmann-La Roche Ltd, Switzerland
  • Suzette  Kox, MPharm
    Suzette Kox, MPharm Senior Director International-Biosimilars Medicines Group
    Medicines for Europe, Belgium
  • Elena  Wolff-Holz, MD, PhD
    Elena Wolff-Holz, MD, PhD Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor
    Paul-Ehrlich Institut, Germany
  • Christian  Schneider, DrMed
    Christian Schneider, DrMed Head of Biopharma Excellence and Chief Medical Officer (Biopharma)
    PharmaLex, Denmark

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