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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

Modernise the publishing process, prepare your submissions team and confidently adopt eCTD 4.0

Consolidate your understanding of the latest eSubmissions updates, spotlighting — Project PRISM, Project Orbis, Structured Content Authoring, Generative-AI and Real-World Evidence

Learn from the best practices of EMA, Medicines for Europe, Accumulus Synergy, Tiefenbacher Group and Boehringer Ingelheim

Accelerate your eSubmissions and keep up to date with changes around the world

Take advantage of the latest developments in global submissions and publishing

  • Apply the latest learnings of artificial intelligence (AI) through industry application case studies 

  • Understand the benefits of cloud based submissions through Project PRISM

  • Prepare for the future of global esubmissions through our big picture panel  

Utilise the expertise of industry peers to accelerate compliance

  • Navigate the current status of eCTD across Europe with help from the EMA

  • Ensure data sufficiency through our deep dive presentation on harvesting and using real world evidence  

  • Understand the importance of structured content authoring alongside Tiefenbacher Group

Enhance collaboration through harmonisation initiatives

  • Benefit from first-hand experiences on submitting under Project Orbis through our multi-stakeholder panel 

  • Expedite regulatory innovation through Accumulus Synergy  

  • Pave the way for continuous eCTD development with our focused, regional updates