7th EBE annual regulatory conference on ATMPs – “Advancing the Delivery of ATMPs to Patients”
“Advancing the delivery of ATMPs to patients”
7th Annual Regulatory Conference organised by the European Biopharmaceutical Enterprises (EBE)
4 December 2018 – Hilton London Canary Wharf, Marsh Wall, South Quay, London E14 9SH, UK
NEW!!! Presentations now available
Session 1: Efficient approaches to evidence generation for regulatory approval and health technology assessment of ATMPs
K. Genenz, Takeda: Efficient approaches to evidence generation for regulatory approval and health technology assessment of ATMPs: The industry experience
A. Tavridou, EMA: EMA experience on joint scientific advice. EMA/HTA with ATMPs
C. Guilhaume, EUnetHTA: HTA body (HTAb) experience on joint scientific advice/early dialogues EMA/HTA with ATMPs
Session 2: Meeting requirements for longterm follow-up of ATMPs in the post-authorisation phase:
C. Voltz, EMA: ATMPs guidelines on safety and efficacy follow-up and risk management
L. Adegeest, Celgene: Changing the course of human health through bold pursuits in science: CAR T Cell Therapy Registries – Industry perspective
A. Schiel, NoMA: HTA’s body perspective on registries
E. McGrath, EBMT: Meeting requirements for long-term follow-up of ATMPs in the postauthorisation phase: Registry holder perspective
Session 3: Complexity of innovative manufacturing and the associated challenges for comparability
B. Greener, Celgene:Industry Perspective on Comparability Challenges with ATMPs
A. Herrero, Takeda: Comparability challenges for allogeneic cell therapy products
S. Briggs, Novartis: Comparability for ATMPs – Challenges and solutions
M. Menezes-Ferreira, CAT: Complexity of innovative manufacturing and the associated challenges for comparability. European Regulators views
Session 4: Stakeholder perspective on optimizing delivery of ATMPs in the healthcare systems
M. Abou-El-Enein, Charité Universitatsmedizin Berlin: Optimizing delivery of ATMPs in the healthcare systems: viewpoint from a healthcare professional
M. Driessens, EGAN: Delivery of ATMPs to patients. Gene therapy for hemophilia – View of a patient organisation
P. Ginty, Catapult: Advanced Therapy Delivery from NHS – clinical infrastructure requirements
E.J. van Lente, AOK: Healthcare systems – Payer’s view
Delivering the promises of advanced therapies to patients requires marketing authorisation as well as successful outcomes of the health technology assessment and reimbursement negotiations.
EBE’s 2018 conference will explore how fostering collaboration between regulators, HTA bodies, payers and other stakeholders can help ATMP developers meet evidence requirements for better patient access.
Join us this December in London for a lively and informative discussion with a variety of high-level speakers from regulators, HTA bodies, patients, payers, and the industry.
The draft Programme is now available here.
Looking forward to seeing you in London on 4 December 2018.
The EBE Team