Data Management and Digitalisation in Regulatory Affairs

Data Management and Digitalisation in Regulatory Affairs
Module 12 of the MSc and Masterclass: 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).

 31 January - 2 February 2024
Where: Online 
Day 1 start time: 10:30 | Day 3 end time: 15:00

Also available as a face to face course, please click here for the face to face registration option

Course overview

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

Benefits to delegates

This course will enable you to:

  • 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
  • Identify issues with electronic compliance
  • Make recommendations about regulatory information management and IDMP strategies
  • Critically analyse data and documentation strategies and processes
  • Critically appraise regulatory processes and documentation
CPD: This course provides 19 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


A copy of the current programme can be downloaded HERE

Module Leader

  Peter Embley


Remco Munnik – Director at Iperion (a Deloitte business)

Dennie van de Voort  Junior Manager at Iperion (a Deloitte business)

Dorien de Vries – Senior Consultant at Iperion (a Deloitte business)

Amy Williams – Director at Iperion (a Deloitte business)

Suitable for

  • 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



    • TOPRA MSc students: £1,545 +VAT*
    • Delegates: £1,785 +VAT*

    Discounted places

    A limited number of discounted places are available at the rates below. Please email us at for a discount code before making your booking.

    • Those working for regulatory agencies, government agencies or academic institutions: £1,338.75 +VAT*
    • Those working for charities, patient groups or in full-time education: £892.50 +VAT*

    *VAT, if applicable, is charged at the rate of 20%.

    Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer.

    Terms and conditions

    Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.

    31/01/2024 10:30 - 02/02/2024 15:00
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