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Global Pharmaceutical Regulatory Affairs Summit
21-23 October 2025
Hotel Palace BerlinBerlin, DE
21-23 October 2025
Hotel Palace Berlin,
Berlin, DE

Bolster Pharmaceutical Compliance with Comprehensive Regulatory Updates on IDMP, RIM, Global E-Submissions, Legislation and Global Markets

Unlock the blueprints to successfully structure your common technical document guided by direct feedback from the EMA, Competent Authorities and seasoned industry experts

CUTTING-EDGE REGULATORY UPDATES FROM THE 2024 EVENT

The Regulations behind the Operations: Regulatory Guidances and Legislative Landscape

  • Dive into and gain timely updates on the Revision of the EU Pharmaceuticals Legislation
  • Understand the hottest regulatory updates including the EU AI Act, Gene Therapy Definitions and Cross-Border Clinical Trials
  • Curate effective strategies in line with environmental legislation

Regulatory Information Management and Data Initiatives

  • Hear first-hand from regulators on the status of IDMP across all markets including Europe, UK, Switzerland, US, and Canada
  • Reap the benefits of reflections on supply shortages, UNICOM, data governance, utilising AI and justifying RIM journeys
  • Delve into data Initiative Case Studies including eAF, PQ/CMC, PLM, FHIR & G-SRS

Exclusively Virtual: Regulatory Affairs in Global Markets

  • Navigate the latest updates on convergence and reliance across all emerging markets
  • Discover the current status’ of regulating advanced therapies globally
  • Keep up-to-date with global use and acceptance of real world evidence

Global eSubmissions: The Future of eCTD 4.0 and Beyond

  • Current status of eCTD V4 implementation across Europe and industry’s current experiences
  • Unpick industry reflections on structured content authoring, generative-AI, and ICH M4Q
  • Immerse in updates from projects including PRISM, Accumulus Synergy and Orbis

Anette Esbensen

Principal Advisory Consultant

NNIT

Fantastic GPRAS 2023 with a great agenda, good presentations and sessions, great opportunity to network. I will see you next year.

CONNECT WITH KEY BUYERS AT GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS SUMMIT 2025

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.

Contact Lisa Marzoli: LisaM@informaconnectls.com