TOPRA: Data Management and Digitalisation in Regulatory Affairs

When: 1-3 December 2021
Where: TOPRA Office, 3 Harbour Exchange, London, E14 9GE, United Kingdom
Start time day 1: 14:00 GMT | End time day 3: 15:00 GMT

Regulatory affairs has always involved dealing with large quantities of data, from nonclinical data to post-market pharmacovigilance. The complexity of the analysis is increasing. This course will cover:

  • data management in daily RA work
  • digitilisation
  • EMA telematics strategy
  • eCTD
  • EMA’s collaboration and strategy
  • archiving of RA documents
  • CSV
  • regulatory information and management
  • regulatory intelligence and knowledge management
  • IDMP
  • big data approaches to regulatory affairs


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