3rd Joint DIA-EUCOPE Workshop on ATMPs, Innovative Gene and Cell Therapies in the EU

Advanced Therapy Medicinal Products (ATMPs), such as gene therapies that consist of or contain Genetically Modified Organisms (GMOs) need to comply with the European Union (EU) GMO legislation, as implemented in each EU Member State, before a clinical trial can commence. Complying with GMO requirements is complex, varies significantly across EU Member States and is leading to delays to clinical trials with ATMPs. Such delays and varying implementation of the GMO legislation makes the EU less attractive as a region to conduct clinical trials with investigational gene therapies. This is detrimental to EU patients, since their timely access to these transformative, potentially curative medicines is delayed.

Join this session to hear the perspectives of regulators and developers on what is causing headwinds for ATMPs in the EU. We will explore together how existing administrative burden can make space for procedural efficiencies and, as a result, better patient access to transformative treatments.