This session focuses on the transformative impact of the latest EU pharmaceutical legislation reforms on the pharma and biotech industries. Panelists will detail the implications of these changes, following the European Commission’s comprehensive overhaul, marked by the adoption of a new Directive and Regulation. Topics will include:

• Examining how the new Directive and Regulation, replacing existing pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC), influence market access strategies and innovation within the pharmaceutical industry
• Devising strategies for adapting to new requirements under the revised legislation, focusing on authorization, monitoring, labeling, and marketing of medicinal products, as laid out in the new Directive and Regulation proposals
• Assessing the implications of these reforms on clinical trial frameworks and data management, particularly the transition to the new clinical trials framework under Regulation (EU) 536/2014 and the management of health data sources
• Understanding the new legislation’s impact on Advanced Therapy Medicinal Products (ATMPs) and other innovative therapies, including the European Commission’s focus on the development and regulation of these treatments