Day 2Wednesday, 21 May 2025 - CET/CEST (Cent Europe Summer, GMT+2)

• Future direction of travel for the EU Commission and DG Sante

• Future direction of travel for the EMA: reflections and priorities

• Update on progress of the EU Pharmaceutical Legislation revision
• Recent developments in the legislative process
• Member States’ positions

• Update on new EU legal instruments to address shortages of critical medicines
• Harnessing lessons from legal requirements implemented in other industries
• How might a potential Critical Medicines Act interact with launch and supply requirements in the EU Pharmaceutical package?
• Understand the impacts on (bio)pharmaceutical companies and supply chains: what will the industry be required to notify and when?

• How is New Active Substance (NAS) designation being applied and what are the legal remedies if you do not agree?
• Learnings from the Sanofi Nexviadyme court case and evaluation of the broader legal implications for future regulatory strategies to achieve NAS designations
• Proactive strategies for your MAA to justify the status of NAS designation

Briefing on the latest developments and proposed revisions to streamline the regulatory process

• EMA policy on conflicts of interest: where do you strike the balance?
• Learnings from the D&A Pharma and Pharma Mar cases
• Other recent cases related to conditional marketing authorisations: the Traslarna and the Ocaliva cases

• Understanding of how the HTAR is now operating in practice for Oncology & ATMPs
• Reality of managing timelines and data requirements
• Practical experience of Joint Clinical Assessments (JCAs) under the HTAR
• Update on implementing regulations

• Possibilities and limits when supplying medicines: review of frameworks for early access, compassionate use and continued access to study drugs for clinical trials
• Product liability and payment implications
• Practicalities of organising supply: legal and practical challenges for protocol agreements with Member States, and supply on an individual basis

• Examining the pathway for products beginning under hospital exception to receiving a MA from EMA
• Update on negotiations for future legislation: how far can authorities stretch exemptions
• Pros, cons and risks of extending the scope of hospital exemptions under the new pharmaceutical package
• Long-term implications for patient care and the market: will we see a rise of hospitals competing with pharmaceutical companies? Or an increase in public-private collaboration?