DIA’s mission – to work across the healthcare continuum to ensure patients receive the therapies they need – is more essential than ever during times like these. DIA acknowledges the time and effort that has gone into planning and preparing for the Joint DIA-EUCOPE Workshop on ATMPs, Innovative Gene and Cell Therapies in the EU, and trusts that everyone will understand the need to respond to current, evolving health concerns in a responsible manner. These precautions are being taken to ensure the health and safety of our entire, global DIA family.
DIA is committed to exploring all possible avenues to provide a productive setting and a fulfilling meeting experience. We appreciate your patience as we work through technical requirements and any potential challenges.
The 2nd Joint DIA-EUCOPE Workshop on ATMPs, Innovative Gene and Cell Therapies is a unique opportunity to hear directly from the Industry and Regulatory representatives about the challenges, opportunities and political implications of advanced therapies. This workshop will include a wide range of topics that will help you and your team 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.
What will be discussed?
In our very successful 2019 edition, we discussed learnings from the first product approvals and launches in Europe, focusing on challenges faced in both regulatory pricing and reimbursement approval. Participants explored hot topics such as hospital exemptions (already allowed in Germany), the importance of registries as a source of data for HTA and regulatory decision-makers, cross-border healthcare and newer payment models.
• Development challenges and solutions for cell and gene therapies
• Regulatory tools and pathways, incl. early interaction with decisions
• 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
Who should attend?
- Research and Development, Regulatory and Access Professionals from Organisations develpoing Cell and Gene therapies
- Regulators, payers and patients who are impacted by or participating in the decisions or policies related to Cell and Gene
Maren von Fritschen, PharmD • Head EU Regulatory Policy
Alexander Natz, JD • Secretary General
European Confederation of Pharmaceutical Entrepreneurs, Belgium
Thomas Bols, MA • Head of Government affairs and Patient Advocacy, EMEA & APAC
PTC Therapeutics, Inc., Switzerland
Sara Torgal, MPharm • Senior Manager, Scientific Programs