When: 18-20 November 2025
Where: TOPRA office, 3rd Floor City Reach, 5-6 Greenwich View Place, London, E14 9NN, UK
Day 1 start time: 10:30 | Day 3 end time: 15:00
This course is also available to attend online.
Suitable for
This course is essential 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.
Course information
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 regulatory affairs work
Digitalisation
European Medicine Agency (EMA) telematics strategy
Electronic Common Technical Document (eCTD)
EMA's collaboration and strategy
Archiving of regulatory affairs documents
Computer System Validation (CSV)
Regulatory information and management
Regulatory intelligence and knowledge management
Identification of Medicinal Products (IDMP)
Big data approaches to regulatory affairs
Benefits of 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 15 CPD hours on successful completion.
To learn more about why continuing professional development is important, visit our Lifelong Learning page.
Programme
You can view and download the programme here.
Module Leader
Presenters
The expert presenters for this training course are:
- Remco Munnik, President, IRISS Forum and previous Director within Deloitte
- Dennie van de Voort, Regulatory Affairs Specialist, Intracare and previous Junior Manager within Deloitte
- Dorien de Vries, Consultant Life Sciences, Precedence and previous Senior Consultant within Deloitte
- Amy Williams, Enterprise Data Governance Lead, Jazz Pharmaceuticals and previous Director within Deloitte
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,900.00 + VAT* |
Standard Price
Non-member |
£2,375.00 + VAT* |
TOPRA MSc Students
|
£1,650.00 + VAT* |
*VAT, where applicable, is charged at the rate of 20%.
| Discounted training course registration fees |
| Event Registration Type |
Price (GBP) |
Government or academic rates
TOPRA Member
|
£1,425.00 + VAT* |
Government or academic rates
Non-member
|
£1,781.25 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£950.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£1,187.50 + VAT* |
Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
Please email meetings@topra.org for a discount code before making your booking.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.