Day 3Thursday, 21 May 2026 - CET/CEST (Cent Europe Summer, GMT+2)

• Progress and timelines for the European Health Data Space
• Member State approach and progress
• Legal frameworks for sharing digital patient data amongst multiple partners
• Practicalities of implementation from mapping and cataloguing data to controls around sensitive data

• Privacy and anonymisation: decision on EU Court of Justice in Deloitte Case and repercussions for the pharmaceutical sector
• Defining the boundaries of anonymization under GDPR and its impact on leveraging clinical data for AI innovation
• Global data dynamics: US and Chinese data export restrictions and requirements
• Practical questions for EU HQ companies following the US Final Rule on Prohibiting and Restricting Transfer of Bulk Sensitive US Personal Data

• Insights into the FDA Commissioner’s National Priority Voucher program and its industry impact.

• A theoretical case study on FDA uncertainty affecting orphan drug development.

• Exploring the FDA-EU interplay in orphan drug market approval processes.

This case study will discuss legal and practical challenges during a research collaboration and the use of an algorithm to help identify disease indicators in electronic health records

• AI Act, GDPR, MDR, IP, prohibition on inducements, in the context of a research collaboration about the use of an algorithm to help identifying disease indicators in electronic health records

This case study delves into the legal approach and guardrails for patient interactions

• Legal boundaries for patient recruitment, early access, and post-trial supply obligations
• Frameworks to engage with patient advocacy groups to incorporate the patient voice into study design
• Regulatory limits on patient support programmes and communication to patients

• The future of comparative advertising
• Regulation of disease awareness campaigns and unbranded campaigns
• Rethinking HCP engagement: hospitalities, samples, and transparency disclosure

• Risks and complexities of combination products or companion diagnostic and potential repercussions of adverse events from off-label use and the application of the new Product Liability Directive

• Do your current internal social media guidelines help you meet your business objectives?
• Assessing the practicality of industry guidelines for product promotion and disease awareness amid a global social media landscape, evolving consumer profiles, and changing communication strategies
• Legal approach to developing a holistic risk-based approach to social media

• Understanding the obligations for Urban Wastewater Treatment Directive, EU rules on Packaging and Packing Waste, Environmental obligations in the new Pharmaceutical Legislation and the implications for your organisation
• EU Omnibus regulation: preparing for changes to European sustainability disclosure regulations
• Practicalities for managing the deluge of legislation and obligations around ESG, corporate responsibility and environment

• Understanding the legal frameworks for green claims including Unfair Commercial Practices Directive, Empowering Consumer Directive and the Green Claims Directive
• What do your obligations to provide clear and relevant information concerning environmental or social claims mean in practice?
• How marketing can use sustainability to differentiate while staying compliant

• FCPA enforcement trends in the US: heightened focus on healthcare compliance, individual accountability, and evolving enforcement priorities impacting corporate practices
• FCPA's global reach: expanding application outside the US, with implications for international competitiveness and compliance challenges
• EU Anti-Corruption Directive progress: advancing efforts to unify anti-corruption laws across member states, signalling stricter compliance requirements ahead
• Global enforcement dynamics: increased collaboration among international regulators, targeting bribery and corruption in key industries