Expert Q&As
First interactions with EMA - Q&A 3
Why is early engagement with EMA, payers, KOLs, and patient groups so important?
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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
First interactions with EMA - Q&A 8
What are Early Access Programs (EAPs) in Europe, and how can they help gather real-world data?
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First interactions with EMA - Q&A 6
What CMC (Chemistry, Manufacturing, and Controls) expectations in the EU might surprise biopharma companies?
