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Hotel Bildungszentrum 21

29 oct 2019 8:30 a.m. - 30 oct 2019 5:30 p.m.

Missionsstrasse 21, 4003 Basel, Switzerland

1st Joint DIA-EUCOPE Workshop on ATMPs, Innovative Gene and Cell Therapies in the EU

Perspectiva general

This workshop on cell and gene therapies aims to meet the needs of the developers of advanced therapies to discuss a range of topics that will help them make more informed decisions on regulatory strategies and evidence packages - as well as market access challenges - which are key topics for cell and gene therapy developers.

It will feature speakers from regulators, payers, patients, industry and academic organisations. Participants will benefit from the direct interaction with these stakeholders as a part of the main programme and during the networking events.

Temas destacados

  • Development challenges and solutions for cell and gene therapies
  • Regulatory tools and pathways, incl. early interaction with decisions
  • Emerging gene editing technologies and the ethical challenges
  • Hospital exemption issues
  • Post-licensing evidence with examples from country-level initiatives
  • HTA and value assessment for curative therapies with high upfront fee
  • Case study for a launch in Europe

¿Quiénes deben asistir?

  • R&D, regulatory and access professionals from organisations developing cell and gene therapies
  • Regulators, payers and patients who are impacted by or participating the decisions or policies related to cell and gene therapies

Comité del programa

  • Alexander Natz, JD
    Alexander Natz, JD Secretary General
    European Confederation of Pharmaceutical Entrepreneurs, Belgium
  • Maren von Fritschen, PharmD
    Maren von Fritschen, PharmD Drug Development and Regulatory Affairs - MSC Course
    University of Applied Sciences, Germany
  • Inka Heikkinen, MBA, MSc
    Inka Heikkinen, MBA, MSc Regulatory Policy Lead
    Lundbeck, Denmark
  • Thomas Bols, MA
    Thomas Bols, MA Head of Government affairs and Patient Advocacy, EMEA & APAC
    PTC Therapeutics, Inc., Switzerland

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