On March 18, the first lecture of the LithuaniaBIO lecture series, organized together with association members Sorainen, “EU Biotech Playbook: Core Legal Issues & Regulatory Hurdles”, took place in Vilnius.
The session was delivered by Sorainen partner Lise-Lotte Lääne, who leads the firm’s Life Sciences & Healthcare sector group. During the lecture, she provided an in-depth overview of the complex and rapidly evolving European Union regulatory landscape that biotech companies face across all stages – from early development to market entry.
Particular attention was given to the structure of the EU regulatory framework, highlighting the increasing role of directly applicable EU regulations. Ongoing initiatives such as the EU Pharmaceutical Package and the proposed Biotech Act were also discussed, both aiming to accelerate innovation while maintaining high standards of safety and compliance.
The lecture explored different regulatory pathways depending on the nature of the product – whether medicinal products, medical devices, food, or other biotech applications. It was emphasized that classification often depends not on the technology itself, but on its intended use, making early strategic decisions especially critical.
Lise-Lotte Lääne also shared practical insights into common pitfalls, including late consideration of regulatory requirements, insufficient intellectual property strategy, poorly structured contracts, and limited attention to data protection and cybersecurity. It was highlighted that early-stage decisions often determine both future risks and overall business success.
The session also underlined the importance of considering early commercialization strategies, such as licensing or alternative applications of technology, allowing companies to generate value sooner while reducing regulatory and financial risks.
This lecture marks the beginning of a broader lecture series aimed at strengthening the Lithuanian biotech sector’s capabilities in legal and regulatory matters and fostering closer collaboration across the ecosystem.
Thank you to everyone who joined – and especially to our partners at Sorainen for this valuable session, and to RockIT for kindly hosting the event!
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The next lecture, “From discovery to deal: Creating, protecting and licensing intellectual property”, will take place on April 29. Save the date – more information and registration coming soon!
