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Global Pharmaceutical Regulatory Affairs Summit


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22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event
22-24 October 2024
Sheraton Brussels Airport, Brussels,
Hybrid Event

Optimise your regulatory information management system to streamline workload, enhance data usability and support submissions

Future-proof your regulatory processes with insight into IDMP, artificial intelligence/machine learning, ESMP, data governance, PLM, ICH M4Q and G-SRS

Benchmark with regulators and pharma thought leaders representing EMA, MHRA, Health Canada, Medicines Evaluation Board, Boehringer Ingelheim, GSK, Shionogi Europe & more

Move Towards Digital Transformation with Harmonised Regulatory Data and Processes

Gain first-hand feedback from prominent working groups

  • Discover life before UNICOM and taskforces  

  • Get up to speed with the latest updates from ICH MQ4, CTADHL and ACCURDIS 

  • Implement effective master data and data governance strategies with learnings from CSL Behring and ALKALOID 

Future-proof your RIM system and regulatory operations team

  • Get ahead of the curve on AI/ML and data flow maps through industry case studies  

  • Enhance end to end RIM capabilities through digitalisation, with help from Roche

  • Examine and apply the skills needed for the future through our big picture panel  

Navigate on-going data standards and initiatives

  • Explore the latest IDMP updates from EMA, FDA. MHRA and Health Canada

  • Understand the latest developments with G-SRS, EU-SRS and GIDWIG  

  • Gain guidance on the latest standards and working practices including FHIR, eAF, ePI and ESMP