In sensitive, high-value life science transactions, clean rooms require more than technical safeguards; they demand clear governance structures and documented accountability. This discussion will explore how legal teams can design oversight frameworks, define escalation protocols and maintain irreproachable audit trails that withstand third-party scrutiny and post-transaction challenge.

This session examines the legal and structural complexities facing small-to-medium-sized life science companies when pursuing licensing, collaboration, joint venture and M&A agreements with larger, more established players in the market. Participants will examine how life science SMEs can structure transactions strategically to optimise valuation, protect foreground and background IP and retain sufficient governance control to support secondary patent filings and pipeline expansions.

This session examines the legal and governance challenges that arise when life sciences companies engage in joint advocacy through trade associations, industry coalitions and collective policy initiatives. Participants will examine how companies can structure regulatory engagement and industry collaboration to support effective advocacy while implementing appropriate safeguards to prevent anti-competitive coordination.

The growth of online pharmacy platforms and sustained parallel trade across the EU has intensified pressure on pharmaceutical trademark rights, particularly where medicines are repackaged and relabelled for distribution across borders. This roundtable will explore the practical strategies companies are deploying to monitor digital marketplaces, challenge unlawful repackaging and coordinate cross-border enforcement while remaining aligned with EU principles on exhaustion and competition law.

This session will examine evolving ESG obligations affecting the life sciences sector, including the revised Urban Waste Water Treatment Directive and its potential cost-allocation consequences for pharmaceutical manufacturers. Participants will explore the new European ESG legislation and discuss how environmental liability exposure, supply chain transparency requirements and new reporting standards are reshaping risk management frameworks and long-term operational planning across the industry.

Ongoing amendments and transitional extensions are continuing to reshape the practical implementation of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) across the EU. This session will outline the latest updates to these legislations and explore the persisting uncertainties and challenges for legal teams managing medical device and IVD portfolios.

The EU Biotech Act introduces both political ambition and significant legal uncertainty, with key questions remaining around its scope and implementation. This roundtable will examine the practical challenges, transitional ambiguity and strategic opportunities arising from the new legislation and assess how biotech companies can leverage the Act to reposition their competitive footprint in Europe.

U.S. product liability continues to represent a material litigation risk for life sciences companies, with multidistrict litigation and escalating jury awards intensifying exposure. This roundtable will examine how pharmaceutical and medical device manufacturers are structuring their defence strategy in this space and mitigating against financial reputational damage.

The recent, high-profile Munich Regional Court I decision on aflibercept has brought renewed focus to the application of the Doctrine of Equivalents in pharmaceutical patent disputes. The court’s reasoning has significant implications for the scope of protection available to originators and the freedom-to-operate assessments undertaken by biosimilar entrants in crowded, high-value markets. This session will examine the aflibercept decision, its interaction with established German and European equivalence case law and its potential consequences for generic launch and future pan-European injunction proceedings.

This roundtable will examine the legal and strategic implications of the EU SPC manufacturing waiver, focusing on its “safe harbour” role in enabling export and day-one EU market entry while reshaping originator exclusivity planning in the final phase of IP protection. Participants will assess notification requirements, stockpiling constraints and enforcement exposure, considering how originators and generics are adapting to core challenges and shifting strategies in response to new legislation and case law.