👨‍⚖️ Chair: Isabelle Poirot-Mazères, Full Professor, President of AFDS, Université Toulouse Capitole

🎯 Objective: Explore the specificities of the regulatory framework in Europe and compare with other regions. Discuss the necessary adjustments and challenges related to international regulation.

9:30 The contributions of the pharmaceutical package in the field of ATMPs: between the new definition of gene therapy medicinal products and regulatory sandboxes?
🎓 Mathieu Guerriaud, Full Professor, UBE – AEDEP, EAHL, CREDIMI

9:50 The Regulation of ATMPs in the USA: What Differences with the EU?
🎓 Erika Lietzan, Full Professor, Missouri University

10:10 The Reality of the Regulatory Framework for ATMPs
🏥 Heloise Mignot EMA

10h30 Discussion and break

11:00 How can competition law regulate mergers in biotech companies producing ATMPs?
🎓 Clotilde Fortier, Full Professor, Directress of Credimi, UBE

11:20 CRISPR and GMO Regulation: Navigating the Intersection of Biotechnology, Public Health, and Legal Frameworks
🎓 Alessandro Nato, Postdoctoral Researcher Università di Teramo & Luiss Roma

👨‍⚖️ Chair: Eric Loquin, Professor Emeritus, former Director of Credimi, UBE

🎯 Objective: Identify specific legal challenges related to ATMPs: liability of actors, regulation of cross-border circuits, tensions between commercial logic and ethical principles.

14:00 What legal liability arises in case of ATMP failure?
🎓 Valérie Siranyan, Full Professor, Université Lyon 1 Claude Bernard – AEDEP

14:20 Manufacturing ATMPs and cross-border travel of cells: what challenges?
🎓 Tamara Hervey, Full Professor, City Univ. London 🇬🇧
🎓 Mirko Dukovic, Postdoctoral Researcher 🇲🇪 / Hertie School 🇩🇪

14:40 Discussion

15:00 Development of the ATMP market: risk or opportunity for consumer law?
🎓 Guillaume Rousset, Full Professor, Director of CRDMS, Université Lyon 3 Jean Moulin 

15:20 The non-commercialisation of human body elements (SoHO) and ATMPs
🎓 Isabelle Moine-Dupuis, Associate Professor with HDR, Dijon 🇫🇷
🩸 Jean-Baptiste Thibert, Director of EFS Rennes 🇫🇷

👨‍⚖️ Chair: Didier Truchet, Professor Emeritus, Université Paris 2 Panthéon-Assas – Honorary President of AFDS

🎯 Objective: Examine the consequences of ATMPs on patients’ rights (consent, access, prioritisation) and analyse how these therapies are perceived in society, including beyond the healthcare sphere.

9:00 Is informed consent adapted to innovative therapies?
🎓 Laura Kadile, Assistant Professor, University of Riga 🇱🇻

9:20 ATMPs and their challenges, the perspective of an industry representative (Gilead)
💼 Pierre Sinet, Industrial Pharmacist 🇫🇷

9:40 Discussion

10:00 Hospital accessibility of ATMPs in France: cross-analysis of consumption data and the regulatory framework
🎓 Blandine Juillard-Condat, Assistant Professor and Hospital Pharmacist, Université de Toulouse 3 Paul Sabatier – CERPOP & IRDES – AEDEP 

10:40 Discussion and break

11:00 Misuse of ATMPs: genetic doping? Myth or reality?
🎓 Cécile Chaussard, Associate Professor with HDR, UBE 🇫🇷
🎓 Claire Sourzat, Associate Professor, UBE 🇫🇷

11:30 Discussion and Lunch

👨‍⚖️ Chair: Olivier Debarge, Full Professor, President of AEDEP 🇫🇷

🎯 Objective: Debate the protection of innovation, funding models for ATMPs, and the practical conditions for equitable access for patients.

14:00 Round Table 1: IP and patentability (cells, DNA, biosimilars)

💼 Stéphane Oudin, PhD, Industrial Property Attorneys

💼 Matthieu Dhenne, PhD, Lawyer, Member of the Paris Bar

💼 An industry representative (to be announced)

14:30 Round Table 2: Financing access / reimbursing innovations – economic sustainability

📈 Valérie Paris, Economist, OECD

🎓 Rémi Pellet, Full Professor, Université Paris Cité – Paris 5 – vice President of AFDS

🏛 Jean-Patrick Sales (subject to confirmation)

⚖️ Blanka Bartos, Doctor of Law

15:00 Round Table 3: The patient pathway

⚖️ Maxence Cormier, Associate Lecturer, Lawyer – AFDS

💼 Pierre Sinet, Gilead

🏥 Amélie Cransac, Assistant Professor and Hospital Pharmacist, UBE CHU Dijon