Conference programme

Topics will include:

1. Challenging government decisions through judicial review or other avenues?
2.  Enforcement actions – from inspections to criminal prosecutions and individual liability
3. ATMPs and the new regulation on substances of human origin: what will change in the next future?
4. Patient Support Programs regulatory & ethical considerations
5. Franchising in healthcare
6. Medicines pricing
7. Prescription weight loss
8. Regulation, AI and data protection in medical technology
9. Clinical trials and AI
10. The legal significance of Personalized Healthcare
11. Latest trends in licensing and IP transactions in life sciences
12. Deepfakes and synthetic media in life sciences: legal risks and global countermeasures
13. AI in the courtroom: the role of AI in life sciences disputes and global judicial decision-making
14. Regulatory or orphan drug data exclusivity and enforcement
15. Global update on bolar exemption and safe harbour
16. Combating online counterfeiting: strategies and lessons
17. Trade dress protection for pharmaceutical packaging
18. WIPO mediation in life sciences

This panel addresses the growing legal challenges of pharmaceutical and device shortages, exploring contractual, regulatory, and liability issues. Experts will discuss strategies for mitigating risks through scarcity and/or force majeure. The session covers global trade, regulatory, and ethical dilemmas surrounding scarce resource allocation. Attendees will gain insights into proactive legal strategies for navigating life sciences supply chain disruptions.

Navigating AI-assisted inventions and copyright in a multi-jurisdictional landscape With AI-driven discoveries reshaping the life sciences industry, intellectual property laws worldwide are evolving. This session will explore the latest guidance from the USPTO and the US Copyright Office on AI-assisted inventorship and authorship, alongside parallel developments in the European Patent Office (EPO), China, and other major IP jurisdictions. Experts will discuss how different regions are interpreting human inventorship, the risks of AI-generated data in drug development, and global best practices for securing AI-driven innovations in the life sciences sector

This panel will explore the transformative potential of digital health solutions within the life sciences industry, how technologies such as AI, telehealth, wearable devices, and digital therapeutics are revolutionizing drug development, personalized medicine, and patient care. The panel will also address the challenges of data integration, regulatory compliance, and the evolving landscape of global health data privacy laws. Attendees will gain insights into emerging trends and innovations that are shaping the future of healthcare and life sciences, and learn how to leverage these technologies to improve patient outcomes and drive industry growth

Navigating the intersection of patent strategies and antitrust regulations in the pharmaceutical industry: Lessons from the Teva Copaxone Case and other national decisions.

Discuss Teva Copaxone case by European Commission - generic and innovator perspectives on competition law and IP - European and US status regarding divisional patent applications - Sham Litigation as an Anticompetitive Behaviour.

Advancements in gene therapy and personalised medicine continue to revolutionize healthcare, leading to the potential of many new cutting edge treatments and therapies. However, ensuring compliance with regulatory standards and addressing ethical concerns is becoming increasing critical. This field holds immense potential for innovative technologies, such as CRISPR gene editing technologies, but it also raises important questions about patient consent, risks of long-term effects and ethical dilemma in human genetic modification. In this panel, we will look at the potential that gene therapy and personalised medicine hold both from a medical and economic perspective, and consider the associated risks, and ethical and compliance challenges. The panel will consider how regulations can evolve to safeguard patients while fostering innovation, and shaping the future of medicine

In a rapidly evolving landscape, building effective compliance programs has become a strategic imperative for life sciences companies. With rising regulatory demands, technological innovation, and growing societal expectations, how can organizations ensure agile and sustainable compliance? Our panel of legal experts will explore best practices and key challenges to designing robust, future-ready compliance frameworks

Balancing innovation, access, and market competition in a post-pandemic world as the USPTO reviews the link between drug pricing and exclusivity, other regions (including the European Medicines Agency (EMA), China's NMPA, and India's IPO)are also scrutinizing their pharmaceutical patent frameworks. This session will explore the global trends in drug pricing regulation, compulsory licensing, and IP reform, highlighting how different jurisdictions balance innovation incentives with public health priorities. Experts will discuss strategies for multinational pharmaceutical companies navigating evolving IP and pricing policies across key markets