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
- 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.
Ania Mitan • SVP & Managing Director EMEAIS
Paolo Morgese, MSc • Director, EU Market Access and Member Relations
Alliance for Regenerative Medicine (ARM), Belgium
Sam Ringle, PhD • EU Regulatory Affairs Manager
CSL Behring Innovation Gmbh, Germany
Martin Telko, PhD, MS • Global Public Affairs Director for Biomedical Innovation
Sara Torgal, MPharm • Senior Manager, Scientific Programs
Maren von Fritschen, PharmD • EUCOPE Representative & CEO
Addon Pharma, Germany
Keith Wonnacott, PhD • Executive Director, Regulatory Affairs
Pfizer Inc, United States