6th Annual Gene Therapy for Rare Disorders Europe

As more and more companies gear up for clinical activity and near approval decisions, the need to have an in-depth understanding of the regulatory frameworks and how these feed into clinical development and manufacturing processes is as vital as ever.

This year's summit is dedicated to gaining European regulatory clarity to progress efficient and robust gene therapies for rare diseases. By giving voice to pioneering drug developers with success stories to share, experts in regulatory affairs, and the regulators themselves, this meeting is your comprehensive guide to unpicking the thorniest regulatory challenges.

Across three carefully curated days, this streamlined one-track summit will unite key gene therapy leaders from large pharma to ground-breaking biotech, academics to exciting service providers, all with the purpose of paving a way forward to successfully launch gene therapy products in Europe.

Speakers: Eva Andres-Mateos, Senior Director of Translational Research, Atsena Therapeutics, Inês Alves, Patient Expert and Member of the Committee for Orphan Medicinal Products, EMA, Stuart Beattie, Gene Therapy Global Regulatory CMC, Biogen, Angelo Loris, Brunetta Coordinator Italian Associations, Advocacy Council, Gloria Palomo Carrasco, Member of the Committee for Orphan Medicinal Products, EMA, P.J. Brooks, Acting Director, Office of Rare Diseases Research, NCATS, NIH, Anne Douar, Chief Development Officer, Vivet Therapeutics, David Dobnik, Senior Research Associate, Slovenian National Institute of Biology, Niklas Engler, Head Cell and Gene Therapy Strategy, Roche, Ivan Gorbachov, Senior Director, Novartis, Markus Haindl, Global Head Of Gene Therapy and Technical Development, Roche, Thijs Gerritzen, Principal Scientist Process Development, Amarna Therapeutics B.V., Harm Hermsen, Vice President, Global Regulatory Affairs, UniQure, Ivan Gorbachov, Senior Director, Novartis, Markus Haindl, Global Head Of Gene Therapy and Technical Development, Roche, John Johnston, Clinical Assessor, Biologicals Unit, MHRA, Nathalie Lambot, Public Health Advisor: Clinical Trials - Regulatory Affairs, pharma.be, Niamh Kinsella, Global Regulatory CMC Early Development Gene Therapy Lead, Biogen, Amanda Rivière, Manager Regulatory Affairs, Genethon, Nathalie Lambot, Public Health Advisor: Clinical Trials - Regulatory Affairs, pharma.be, Valérie Salentey, Director of Regulatory Affairs and Quality Assurance, Sensorion, Magali Taiel, Chief Medical Officer, GenSight Biologics, Oscar Segurado, Chief Medical Officer, ASC Therapeutics, Violeta Stoyanova- Beninska, Chair of Committee for Orphan Medicinal Products, EMA

Others Details

Brochure: https://go.evvnt.com/1234024-3?pid=6581