Resources
Discover a collection of resources tailored for biopharma companies looking to enter the European market.
Launching in EU - Q&A 10
How can we leverage early access programs and real-world evidence (RWE) to support our European launch?
Launching in EU - Q&A 9
Should we launch ourselves in Europe or consider partnering/outlicensing, and how do we decide?
Launching in EU - Q&A 8
What risk areas should we pay special attention to (pharmacovigilance, legal, compliance, etc.) when launching in Europe?
Launching in EU - Q&A 7
What are the key operational flows we need to set up for product distribution in Europe?
First interactions with EMA - Q&A 8
What are Early Access Programs (EAPs) in Europe, and how can they help gather real-world data?
First interactions with EMA - Q&A 6
What CMC (Chemistry, Manufacturing, and Controls) expectations in the EU might surprise biopharma companies?
First interactions with EMA - Q&A 5
How should we approach pricing and reimbursement across EU countries?
First interactions with EMA - Q&A 4
What is a Pediatric Investigation Plan (PIP) and when should we plan for it in Europe?
First interactions with EMA - Q&A 3
Why is early engagement with EMA, payers, KOLs, and patient groups so important?
Launching in EU - Q&A 6
How do we ensure compliance with local promotional regulations and get our marketing materials approved in Europe?