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Overview

One year further into the life of Biosimilars, this 1.5 days conference will provide an update on the current status for biosimilars in EU and globally. The conference will give an overview of the current regulatory, scientific and market access perspectives for biosimilars, including discussion on a number of Hot Topics in the field. Plenary lectures followed by panel discussions of sufficient length to provide participants an opportunity to bring forward their own experience and share their thoughts and ideas with the experts.

 

One of the highlight hot topics will be the new guidline on biosimilars just published by the European Medicines Agency (click here for details).

Featured topics

  • Current regulatory status of biosimilars in the EU
  • Stakeholders views and experiences with biosimilars
  • The importance of assessing immunogenicity in biosimilar development
  • Interchangeability and switching
  • Global development of biosimilars
  • Global regulatory challenges for biosimilars
  • Naming and labelling of biologicals including biosimilars
  • Market access and pricing of biosimilars in EU

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
  • Patient organisations

Learning objectives

  • Deal with regulatory requirements
  • Scientific and operational challenges and opportunities
  • Exchange experiences and discuss Hot Topics with experts
  • Update the participant on the current knowledge including regulatory and scientific thinking

Program Committee

  • Steffen  Thirstrup, MD, PhD
    Steffen Thirstrup, MD, PhD NDA Group, United Kingdom
  • Sabine  Atzor, RPh
    Sabine Atzor, RPh Head of EU Regulatory Policies F. Hoffmann-La Roche Ltd., Switzerland
  • Suzette  Kox, MPharm
    Suzette Kox, MPharm Senior Director, Scientific Affairs EGA, Belgium
  • Elena  Wolff-Holz
    Elena Wolff-Holz Paul-Ehrlich-Institute, 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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Contact us

Registration Questions
Phone.: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET
diaeurope@diaeurope.org

Agenda and Event Logistics
Nicole Hintersatz, Event Manager
Phone: +41 61 225 51 51 Fax: +41 61 225 51 52
Nicole.Hintersatz@diaeurope.org