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: TOPRA office, 6th Floor, 3 Harbour Exchange, London E14 9GE
Day 1 start time: 10:30 | Day 3 end time: 15:00

Also available as an online course, please click here for the online 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


    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
    CPD: This course provides 15 CPD hours on 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 WilliamsDirector at Iperion (a Deloitte business)

    TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders and are validated by the University of Hertfordshire.

    Remco Munnik, Director, Iperion Life Sciences Consultancy



      • 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.

    • When
      31/01/2024 10:30 - 02/02/2024 15:00
      TOPRA Office 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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