Global Pharmaceutical Regulatory Affairs Summit 2026

Conference Details

Date: 28 September 2026

Time: To be announced

Duration: 3 days

Location: Brussels, Belgium

Cost: £ 2399 - £ 3199

Organiser: Informa Connect

Conference Website

Conference Description

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 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 General Pharmaceutical Legislation (GPL) and geopolitical shifts will affect regulatory strategy and planning;
Identify the skills and organisational structures to future-proof your regulatory team;
Grasp the international harmonisation trajectory and implications beyond eCTD 4.0.

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