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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

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 Director
    NDA Advisory Services Ltd, United Kingdom
  • Sabine  Atzor, RPh
    Sabine Atzor, RPh Director Regulatory Affairs , EFPIA, Belgium
    On Secondment From F. Hoffmann-La Roche, Switzerland
  • Suzette  Kox, MPharm
    Suzette Kox, MPharm Senior Director International, EBG
    EGA, Belgium
  • Elena  Wolff-Holz
    Elena Wolff-Holz
    Paul-ehrlich-Institute, Federal Agency For Vaccines and Biomedicines, Germany
  • Christian  Schneider, DrMed
    Christian Schneider, DrMed Medical Head of Division, Medicines Licensing and Availability
    Danish Health and Medicines Authority, Denmark
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Registration Questions

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+41 61 225 51 51


Agenda and Logistics Questions

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+41 61 225 51 49