This course is also available to attend online.
When: 13-15 January 2026
Where: TOPRA Office, 3rd Floor City Reach, 5-6 Greenwich View Place, London, E14 9NN, UK
Day 1 start time: 10:30 GMT | Day 3 end time: 15:00 GMT
CPD: 15 CPD hours upon successful completion
Who should attend
This course is ideal 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
What you'll learn
By completing this course, you will be able 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
Course overview
Digitalisation is transforming the regulatory landscape, prioritising data integrity, efficiency, and compliance. This course provides you with the knowledge and skills to manage complex data flows across the product lifecycle, from nonclinical research to post-market pharmacovigilance. Topics include data and document management, eCTD, regulatory information systems, eCompliance, and Identification of Medicinal Products (IDMP) standards. You will also learn to navigate digital frameworks, manage large volumes of diverse data, and develop solutions to real world regulatory challenges.
Course presenters
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.
The other expert presenters for this 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 |
£1,750.00 + VAT* |
Standard Price
Non-member |
£2,450.00 + VAT* |
TOPRA MSc Students
|
£1,750.00 + VAT* |
Those working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets, and MSEs (Micro and Small Enterprises) can also access discounted rates by becoming a TOPRA member. For more information about the discounts available, please email meetings@topra.org before making your booking.
Important Notice On VAT
In compliance with regulations, a *20% VAT will be charged to all attendees, regardless of your country of origin. If you have a VAT number or if the company or organisation you are affiliated with has a VAT number or equivalent please ensure it is visible on your profile. If your VAT number is not visible on your profile, please email finance@topra.org to have it updated. If you do not have a VAT number, there is no action required — VAT will be applied accordingly during the registration process. Please observe that the VAT number needs to be valid.
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Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.