EU Biotech Playbook: Core legal issues & regulatory hurdles

LithuaniaBIO and Sorainen proudly present a dedicated lecture series for biotech companies navigating legal and regulatory challenges. The first seminar, taking place on 18th March 2026 at RockIT, Gynėjų str. 14, Vilnius, will guide participants through the complex and rapidly evolving regulatory landscape of European Union law.

The seminar is delivered by Sorainen partner Lise-Lotte Lääne, who is leading the firm’s Life Sciences & Healthcare sector group

Key topics include:

• Overview of the EU regulatory ecosystem for biotech (including the upcoming EU pharmaceutical package and the proposed Biotech Act;
• Main characteristics of different regulatory pathways (e.g. medicinal products, medical devices, novel food, etc);
• Lessons from the practice: where companies most often go wrong in their processes, and how these can derail development timelines and market access, and how to mitigate them before they become value‑critical issues;
• Practical tips for early-stage and scaling biotech companies from the legal perspective.

Participants will leave with a clearer regulatory roadmap, a better understanding of where legal risk tends to arise, and practical insights into how EU reforms may reshape the biotech landscape in the coming years.

This seminar is particularly relevant for:

• Biotech founders and executives
• In‑house legal and regulatory teams
• Investors and advisors in life sciences
• R&D, compliance, and strategy leaders