Day 3Wednesday, 21 May 2025 - 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

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

• 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