21-23 October 2025
Hotel Palace BerlinBerlin, DE21-23 October 2025
Hotel Palace Berlin,
Berlin, DE
Hotel Palace Berlin,
Berlin, DE
The European Regulatory landscape is changing... Keep up or fall behind!
We have all the requirements to ensure you stay on top of your game in these turbulent times
Gain the information you need to ensure a smooth transition in Europe
Are these things keeping you up at night?
- Brexit: Implications for Regulatory Affairs professionals and the industry as a whole with MSD
- Clinical Trial Regulation: The new requirements
- GDPR: Patient data? Clinical data? Regulatory data?
The Regulations affecting the industry
- The EU Paediatric Regulation: Examining the EU Commission’s roadmap with PIP Adviser
- Orphan medicinal products: Current challenges and opportunities and the latest regulatory landscape, hear from Shire
- ATmPs: in the light of precision medicine feedback from Cellectis
Global requirements: where does Europe fit in?
- Requirement considerations between the US and EU. Where do the differences lie?
- Best practice for applying your European registration dossier requirements to emerging markets
- Exploring strategies for implementing a successful variations submission across the globe
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