Sheraton Brussels Airport, Brussels,
Hybrid Event
Ensure Adherence to Regulatory Requirements and Bolster Pharmaceutical Compliance with Comprehensive 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
2024 Agenda Line-Up
As a hybrid event, attendees will have the option to attend either in-person or digitally:
In-Person attendees: Join your peers in Brussels with access to all in-person sessions in tracks 1 & 2 plus live stream access to the digital only Global Markets sessions from the Summit in Brussels.
Digital attendees: Join your peers virtually for the Global Markets track. Interested in other sessions? Access all of the session recordings from the in-person Summit in Brussels post-event.
UNLOCK CUTTING-EDGE REGULATORY UPDATES AND EXCEL TOWARDS REGULATORY COMPLIANCE
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
Are You Interested in Sharing Your Expertise at GPRAS 2024?
CONNECT WITH KEY BUYERS AT GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS SUMMIT 2024
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 Linda Cole: LCole@informaconnectls.com