(*MTI : Règlementation et perspectives) Context In 2023, the European Union launched a major overhaul of European pharmaceutical law through the “pharmaceutical package”, composed of a proposal for a directive and a proposal for a regulation. This reform, commonly referred to as the General Pharmaceutical Legislation (GPL), represents the most significant revision of the European medicinal products framework since the adoption of Directive 2001/83/EC and Regulation (EC) No 726/2004. The current legislation rests on a framework designed almost a quarter of a century ago. Despite numerous amendments, it remains shaped by a conception of the medicinal product largely inherited from the classical industrial model: a relatively standardised product, manufactured through a reproducible process, evaluated in structured clinical trials, and subsequently authorised by means of a marketing authorisation. Contemporary therapeutic innovations, however, profoundly challenge this model. Advanced therapy medicinal products (ATMPs) and products that may be described as “ATMP-like” (such as phages, EVs, RNAs, etc.) shift the traditional boundaries between biological medicinal products, ATMPs, individualised preparations, technological platforms and alternative manufacturing processes. Programme 8:30 - 12:30 Session #1: Regulatory Morning: Impact Analysis of the Pharmaceutical Package The morning session will be devoted to a focused regulatory analysis of the main developments and areas of uncertainty opened up by the GPL for ATMPs and ATMP-like products. The aim will not be to examine the entire reform of European pharmaceutical law exhaustively, but rather to identify the most sensitive issues for innovative therapies. Four questions will be addressed transversally: the evolution of the definition of gene therapy medicinal products, the regulatory pathway applicable to phages, the legal qualification of EVs and, finally, the potential role of regulatory sandboxes. 14:00 - 17:00 Session #2: Industrialisation of therapeutic innovations The afternoon will be dedicated to round tables bringing together industry representatives and field actors from the relevant sectors: gene therapies, cell therapies, phages, bioproduction and related areas. The objective will be to confront the legal analysis developed in the morning with the concrete realities of development, production and industrialisation. This conference therefore seeks to articulate two levels that are rarely brought together within the same event: on the one hand, the legal and regulatory analysis of tomorrow’s categories; on the other hand, the industrial experience of their implementation. Practical information Location ESEO (11 rue de Sully, 21000 Dijon - France) - Presential only Registration Fees Santenov / Genopole members: 250€ HT Non-members: 350€ HT Academic participants: 100€ HT Registration Organized by Santenov Dijon Bourgogne, Groupe IMT, Université Bourgogne Europe - Credimi - CTM, Genopole, EBI Participating organizations : BYoRNA, Bridge project, Centre de transfusion sanguine des armées (CTSA), Evolving Therapeutics, France Biolead, Pierre Fabre, Whitelab Genomics, Yposkesi
