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).


When:
 1-3 December 2021
Where: CCT Venues, 193 Marsh Wall, London, E14 9SG
Day 1 start time: 10:30 GMT | Day 3 end time: 15:00 GMT

Also available as a virtual course, please click here for the virtual 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.

Programme

A copy of the current programme is available to download HERE

Module Leader

  • Peter EmbleySenior Vice President, Regulatory & Health Economic Science at Bionical Emas

Presenters 

 

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

Pricing

    Standard

    • TOPRA MSc students: £1500 +VAT*
    • Delegates: £1700 +VAT*

    Discounted places

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

    • Those working for regulatory agencies, government agencies or academic institutions: £1,275+VAT*
    • Those working for charities, patient groups or in full-time education: £1,275+VAT*

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

    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
    01/12/2021 - 03/12/2021
    Where
    TOPRA Office 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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