21-23 October 2025
Hotel Palace BerlinBerlin, DE21-23 October 2025
Hotel Palace Berlin,
Berlin, DE
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
The All-Star Speakers From Global Pharmaceutical Regulatory Affairs Summit 2024
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