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SUMMARY:EU Biotech Playbook: Core legal issues & regulatory hurdles
DESCRIPTION:LithuaniaBIO and Sorainen law firm proudly present a dedicated lecture series for biotech companies navigating legal and regulatory challenges. The first seminar, taking place on 18th March 2026, 12:00-14:00 at RockIT, Gynėjų str. 14, Vilnius, delivered by Sorainen partner Lise-Lotte Lääne, who is leading the firm’s Life Sciences & Healthcare sector group, will guide participants through the complex and rapidly evolving regulatory landscape of European Union law.
Bringing a biotech product to the EU market requires more than scientific excellence – it demands a clear understanding of a rapidly evolving, highly fragmented regulatory framework. In this seminar, we will explore the core legal and regulatory challenges facing biotech companies across the EU, from early-stage development to commercial scale-up.
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.

Why attend?
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

 
Register to the event here.
URL:https://lithuaniabio.com/events/eu-biotech-playbook-core-legal-issues-regulatory-hurdles/
ORGANIZER;CN=:MAILTO:
CATEGORIES:Renginiai
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