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Data Management and Digitalisation in Regulatory Affairs




London, United Kingdom


20 Nov 2019 - 22 Nov 2019

Reference No: T1907366-TOP

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Key points about this Training Event

  • Explain the importance of data, document and information management
  • Demonstrate a critical understanding of the processes and requirements necessary for completing an eCTD
  • Critically evaluate the IDMP requirements and identify issues with electronic compliance
  • Critically analyse data and documentation strategies, processes and appraise regulatory processes and documentation
Event Description

Course Outline:

This Masterclass will provide you with  the theoretical background to data management, document management, electronic submissions, eCompliance regulatory information management and the new identification of Medicinal Products (IDMP) requirements, and find solutions to practical problems in this area. Deal with large volumes of data and deal with different data (from nonclinical to post-market pharmacovigilance.

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

When & Where?

20 - 22 November 2019 

TOPRA Office
6th Floor
3 Harbour Exchange
South Quay
E14 9GE


Course fee for Delegates £1,700 plus 20% VAT
Course fee for Students £1,500 plus 20% VAT

Applicant Requirements
  • Students of the TOPRA MSc programme
  • Delegates from the medical device industry who wish to develop their knowledge
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject
Reference No: T1907366-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.


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