Tackle Regulatory Changes with Confidence: Unlock Your Next-Level Playbook to IDMP, RIM, eCTD 4.0 & Global eSubmissions
The premier conference to successfully structure your regulatory information management and global eSubmissions processes guided by direct feedback from competent authorities and seasoned experts
New Dates! New Location!
Mark Your Calendars: We've moved to September! Join us at the Radisson Brussels Grand Place in Brussels, Belgium from 28-30 September, 2026. We're hard at work on the agenda and will have more speaker and session announcements in the coming weeks so stay tuned!
Empowering Pharma Professionals to Modernise Regulatory Operations: Expert Submissions, Data Integrity & Digital Transformation
Building on the valuable insights from our dynamic community, we’re set to deliver another game-changing event. Whether you’re returning or joining us for the first time, get ready for an enhanced agenda filled with innovative topics to elevate your regulatory processes. Don’t just hear about it — get a sneak peek into what awaits at GPRAS 2026!
ICH M4 Evolution & CMC Data Transformation
Pinpoint the ICH M4Q roadmap and what it means for your submissions processes by 2028
- Fast-track the move from document-centric to data-centric CMC submissions
Walk away with actionable approaches to implement data quality specifications in CMC
IDMP, SPQS and Regulatory Data Standards
Understand how to integrate IDMP into your submission initiatives and operating models
Obtain governance tactics to align SPQS with IDMP for smoother coordination
Learn hard-won implementation lessons and sidestep common pitfalls
AI-Driven eSubmissions & Document Intelligence
See practical AI use cases for automated classification and intelligent content extraction
Take away predictive quality-check frameworks to de-risk submission timelines
Gain strategies to reduce manual effort with Machine Learning Models (MLM) while preserving submission accuracy
Master Data, Data Governance & Enterprise Platforms
Learn how to establish Master Data Management (MDM) foundations and the right team structures for digital regulatory operations
Walk through enterprise data governance and lifecycle models that support product success
Gain pragmatic transformation tactics that minimize operational disruption
eSubmission Strategies, Modular Approaches & RWD
Acquire modular eCTD strategies you can implement to accelerate submissions and enable reuse
Learn how to integrate Real-World Data (RWD) to strengthen regulatory packages
Build confidence in navigating global eSubmission rules and emerging market
Regulatory Strategy, Policy Change & Future Skills
Anticipate how General Pharmaceutical Legislation (GPL) and geopolitical shifts will affect regulatory strategy and planning
Identify the skills and organizational structures to future-proof your regulatory team
Grasp the international harmonization trajectory and implications beyond eCTD 4.0
The All-Star Speakers Leading the Charge at Global Pharmaceutical Regulatory Affairs Summit 2026
Connect and Network with Key Decision-Makers at Global Pharmaceutical Regulatory Affairs Summit
Whether you’re looking to generate quality leads, showcase thought leaders or reinforce your brand, collaborate with us to identify custom sponsorship opportunities to help you reach your business objectives
Contact Lisa Marzoli to learn more about sponsorship opportunities: LisaM@informaconnectls.com
Introducing Our Not for Profit Media Partner: IRISS Forum
IRISS Forum is a global, non-profit networking organization dedicated to preparing the life sciences industry for regulatory evolution and digital transformation. It facilitates worldwide collaboration among industry professionals, vendors, government agencies, and consultants to advance regulatory information and submission standards. IRISS Forum provides access to global expertise through collaboration, education, and sharing of best practices among passionate professionals addressing both current challenges and future strategic needs. IRISS creates an inclusive forum where stakeholders can work together to implement regulatory standards that benefit the industry, regulatory agencies, and ultimately improve public health outcomes.