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Virtual

May 26, 2021 6:45 PM - May 28, 2021 12:15 AM

(Central Europe Standard Time)

3rd Joint DIA-EUCOPE Workshop on ATMPs, Innovative Gene and Cell Therapies in the EU

Supporting you in navigating the complex regulatory and access landscape.

Overview

Supporting you in navigating the complex regulatory and access landscape

Join us for our 3rd Joint DIA-EUCOPE Workshop on ATMPs, Innovative Cell and Gene Therapies in the EU for the opportunity to collaborate and share expertise in a unique event where thought leaders will come together to partner and share collective intelligence on regulatory, evidence and access challenges for innovative Gene and Cell therapies.

Be informed by experts, join the discussion and be part of the solution

  • Hear directly from regulators, payers, patient representatives, industry and academic organisations through interactive sessions, networking and open forums
  • Take part and share your insights in the first global conference where key stakeholders will discuss how the approval of the COVID-19 vaccine will influence the regulatory landscape for advanced therapies
  • Ignite conversation, collaboration and change in how we improve access to innovative treatments by accelerating their way to the market and ultimately to patients
  • Gain practical knowledge on how to best navigate the complex access landscape of the advanced therapies

Flexible format with interactive sessions

  • This workshop consists of two half-days, in the afternoon CET, so you can better adapt your schedule and attend in parallel to your regular job
  • Networking sessions, combined with a bespoke forum tool will give you the possibility to take the discussion further and drive transformational outcomes

Featured topics

  • Regulatory requirements, considerations and challenges:
    • HTA/Regulatory collaboration on ATMPs
    • Regulatory barriers for developers and for access
    • Scientific advice and the PRIME scheme
    • New Regulations on the EU space
  • HTAs and payers’ preparedness for ATMPs
  • Challenges brought/highlighted by the COVID-19 pandemic in the ATMP space
  • Post-authorisation evidence generation in ATMPs

Who should attend?

  • Research and Development, Regulatory and Access Professionals from Organisations developing Cell and Gene therapies, impacted by the related regulations and policies.
  • Regulators, payers and patients who are impacted by or participating in the decisions or policies related to Cell and Gene therapies.

Program Committee

  • Ania   Mitan
    Ania Mitan Senior Vice President & Managing Director, DIA EMEA and India
    DIA, Switzerland
  • Paolo  Morgese, MSc
    Paolo Morgese, MSc Head of Public Affairs
    Alliance for Regenerative Medicine (ARM), Belgium
  • Sam  Ringle, PhD
    Sam Ringle, PhD EU Regulatory Affairs Manager
    CSL Behring Innovation Gmbh, Germany
  • Martin  Telko, PhD, MS
    Martin Telko, PhD, MS Global Public Affairs Director for Biomedical Innovation
    Novartis, Switzerland
  • Sara  Torgal, MPharm
    Sara Torgal, MPharm Senior Manager, Scientific Programs
    DIA, Switzerland
  • Maren  von Fritschen, PharmD
    Maren von Fritschen, PharmD Head EU Regulatory Policy
    Moderna, Netherlands
  • Keith  Wonnacott, PhD
    Keith Wonnacott, PhD Vice President, Regulatory Affairs
    Lexeo Therapeutics, United States

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