EU Biotech Playbook: Core legal issues & regulatory hurdles

LithuaniaBIO ja Sorainen lõid spetsiaalse loengusarja biotehnoloogiaettevõtetele, kes tegutsevad õigusalaste ja regulatiivsete väljakutsete keskel.

Sarja esimene seminar toimus 18. märtsil 2026 RockITis (Gynėjų tn 14, Vilnius) ning andis osalejatele ülevaate Euroopa Liidu õiguse keerukast ja kiiresti muutuvast regulatiivsest raamistikust. Seminari viis läbi meie partner Lise-Lotte Lääne, kes juhib meie bioteaduste ja tervishoiu sektorgruppi.

Tutvustus inglise keeles:

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