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.
Download our Expert Q&A
Discover our latest news
Expert Q&As
First interactions with EMA - Q&A 1
What are the different regulatory pathways available when expanding to Europe and which one is the best fit for me?
Expert Q&As
First interactions with EMA - Q&A 2
How does the EU drug development landscape differ from the US ?
Expert Q&As
First interactions with EMA - Q&A 7
What regulatory pathway missteps should we avoid, and how can we streamline our EU dossier preparation?
