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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event
22-24 October 2024
Sheraton Brussels Airport, Brussels,
Hybrid Event

SPOR. Bringing the data management and eSubmissions worlds together... Are you ready?

CASE STUDY DRIVEN PRESENTATIONS FROM INDUSTRY TO MAKE YOU DATA COMPLIANT

Regulatory Information Management Day

  • Understand IDMP and SPOR timelines in the EU and beyond
  • Hear examples of handling data migration from XEVMPD to IDMP
  • Master a successful RIM system
  • Share best practices to ensure data quality

Regulatory Submissions and Management Joint Day

  • Gain insight from the SPOR Taskforce
  • Get informed on the Substance Management Service
  • Navigate the CESSP programme with live demonstration
  • Outline the status and timelines of eCTD 4v0

Submissions Day

  • Feedback on submissions in China, GCC and Brazil
  • Best practice for creating a global submission strategy from Bayer
  • Case studies on preparing for the Mandate of National Submissions from GE Healthcare
  • Long term telematic strategy understanding from the Telematic Taskforce