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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
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 Identification of Medicinal Products (IDMP) into your submission initiatives and operating models
Obtain governance tactics to align Structured Product Quality Submissions (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 minimise 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 the New Pharmaceutical Legislation (NPL) and geopolitical shifts will affect regulatory strategy and planning
Identify the skills and organisational structures needed to future-proof your regulatory team
Prepare for harmonisation efforts beyond eCTD 4.0, including ICH initiatives
The All-Star Speakers Leading the Charge at Global Pharmaceutical Regulatory Affairs Summit 2026
Speaker Q&A Download
Speaker Q&A Download
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.
FAQs
What is the Global Pharmaceutical Regulatory Affairs Summit (GPRAS)?
GPRAS is a premier international conference bringing together pharmaceutical regulatory professionals, industry leaders, and regulatory authorities to discuss the latest developments, challenges, and best practices in pharmaceutical regulatory affairs. The summit features expert speakers, interactive sessions, networking opportunities, and practical insights to help you navigate the evolving regulatory landscape.
When and where is GPRAS 2026 taking place?
The GPRAS summit is taking place 28-30 September 2026 at the Radisson Brussels Grand Place in Brussels, Belgium
Who should attend GPRAS?
GPRAS is designed for:
- Regulatory Affairs Professionals
- Quality Assurance Professionals
- Pharmaceutical Industry Executives
- Legal and Policy Advisors
- Regulatory Authority Representatives
- Consultants specializing in pharmaceutical regulations
- Anyone involved in drug development, approval, and regulatory processes
What will I learn at GPRAS?
You'll gain actionable insights on:
- Latest regulatory updates from the EMA, and other global authorities
- Strategies for navigating complex approval processes
- Best practices for risk management
- Emerging trends in pharmaceutical regulations
- Digital transformation in regulatory affairs
- Case studies and real-world applications
- Networking opportunities and industry connections
What topics will be covered at GPRAS 2026?
Key topics include:
- Global regulatory harmonization and divergence
- EMA regulatory updates
- Digital health and AI in regulatory affairs
- Accelerated approval pathways
- Post-market surveillance and pharmacovigilance
- Regulatory strategy for biologics and biosimilars
- Data integrity
- Regulatory considerations for emerging markets and SMEs
Will session recordings be available after the event?
Selected session recordings and presentation materials will be made available to registered attendees after the event, subject to speaker approval. Access details will be sent via email within two weeks after the conference concludes.
Will there be opportunities to meet and network with speakers?
Yes! We've built dedicated networking time into the schedule, including:
- Networking breaks between sessions
- Lunch networking sessions
- Evening reception
- Q&A sessions after presentations
- Exhibition hall where many speakers will be available
How can I maximize my networking opportunities at GPRAS?
- Download the event mobile app to connect with other attendees before the event
- Attend all networking breaks and social events
- Participate actively in Q&A sessions
- Visit the exhibition area
- Join topic-specific roundtable discussions
- Connect with attendees on LinkedIn using the event hashtag #GPRAS
Who organizes the Global Pharmaceutical Regulatory Affairs Summit?
The summit is organized by Informa Connect, part of Informa PLC. View more of our biotech and pharma events here.
Where can I find the detailed agenda?
The detailed agenda is available to view here and to download below: