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Global Pharmaceutical Regulatory Affairs Summit
23-25 October 2023
DoubleTree by Hilton, Brussels

23-25 October 2023
DoubleTree by Hilton, Brussels

The only conference leading the way in IDMP, RIM, Global eSubmissions and Regulatory Affairs in Global Markets

With guidance direct from regulatory authorities and industry leaders, providing insights into policy and real-world case studies to help you achieve your compliance goals.

Delivering the need-to-know updates across IDMP, RIM, eSubmissions and global regulatory affairs

IDMP: Don't get left behind

  • IDMP implementation guidelines have arrived. Review the latest EU guidance with SPOR Taskforce members
  • A one-stop shop for feedback and input from Health Canada, EMA and the European Commission, ABPI
  • The RIM and IDMP upgrade in under way. Overcome your IDMP challenges on a time-crunch 

Regulatory Information Management: Systems and updates

  • Discuss the specific challenges faced by Regulatory Information Professionals and explore effective approaches to overcome them
  • Move towards digital transformation with harmonised regulatory data and processes
  • Revamp your regulatory infrastructure for faster, better, stronger processes

Global eSubmissions and eCTD V4.0: What's the latest?

  • Get the lowdown on how eSubmissions have progressed around the world
  • Expert insights on eCTD V4.0, overcoming regional hurdles, and key approval considerations
  • Regulatory changes, data standards, eCTD implementation: Gain insight from leading industry pioneers

Regulatory Affairs in Global Markets: Global, APAC, LATAM, MEA

  • Get to grips with global harmonisation efforts, post-pandemic regulatory frameworks and expedited market pathways
  • Hear from regulatory authorities, health agencies and industry associations; SFDA, ANVISA, IFPMA, PAHO
  • Gain the latest insights on key regions: Asia-Pacific, Latin America, Turkey, the Middle East and Africa

Join us in Berlin, 6-8 April

Register for the Berlin Summit to join your IDMP, Regulatory Information Management and Global eSubmissions expert community in-person. Plus, get full access to the Digital Event Platform on 11-13 April, 2022 and benefit from additional virtual networking, re-cap on all of the Berlin session recordings for the days you attended, and tune in for live Regulatory Affairs in Global Markets sessions!

Join us Digitally, 11-13 April

Register for the digital experience to participate in this year’s Regulatory Affairs in Global Markets stream, delivered live in an all-digital format so you can address all of your burning questions in Q&As with the speakers from wherever you are in the world. Plus, benefit from virtual networking opportunities connecting you with all attendees throughout the Hybrid Event.

Interested in IDMP, RIM and Global eSubmissions but unable to travel? Register for the digital experience pass to access all of the session recordings from the in-person Berlin Summit on-demand on 11-13 April.

Rodrigo Palacios

Associate Director, Global Regulatory Policy, Roche

F Hoffmann La Roche AG

The quality of speakers and presentations was excellent as always. I hope we can go back to the in-person setting next year. Thank you!


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