Expert Q&As
First interactions with EMA - Q&A 3
Why is early engagement with EMA, payers, KOLs, and patient groups so important?
Access decades of experience
What’s Inside the Q&A:
Strategic Stakeholder Engagement Timeline
When and how to connect with EMA, payers, KOLs, and patient groups throughout your development journey.
Regulatory Scientific Advice Process
How EMA and national Health Agency consultations work and what guidance you can expect at each development stage.
European Payer Landscape Navigation
Understanding HTA bodies like NICE, HAS, and G-BA, plus new parallel consultation opportunities with EMA.
Risk Mitigation Through Early Planning
Real scenarios showing how proactive engagement prevents costly late-stage program changes and market access barriers.
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Expert Q&As
Launching in EU - Q&A 10
How can we leverage early access programs and real-world evidence (RWE) to support our European launch?
Expert Q&As
Launching in EU - Q&A 1
Why is launching a drug in Europe different from launching in the US?
Expert Q&As
Launching in EU - Q&A 3
How to choose the right location for our European headquarters or hub?
