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