This course is also available to attend in-person.
When: 7-9 July 2026
Where: Online
Day 1 start time: 13:00 BST | Day 3 end time: 15:15 BST
CPD: 15 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Students of the MSc programme
- Delegates from the regulatory affairs industry who wish to develop their knowledge of clinical operations
- 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:
- Understand the practical aspects of Good Clinical Practice and how it supports clinical research
- Identify the regulatory requirements for clinical research in major markets, understand the importance of the EU Clinical Trial Directive and the requirements and practicalities of preparing the required clinical trial applications and associated documentation
- Gain an insight into the complexities and requirements of pharmacovigilance in clinical research
- Understand the management of clinical trial supplies
- Understand the requirements of Good Manufacturing Practice, authorisation and importation of investigational medicinal products
- Understand clinical trial reporting, the management of the data, data auditing and the practicalities of Good Clinical Practice inspections
- Gain an appreciation of the legal and ethical aspects of clinical research, including insurance, indemnity and the role of the ethics committees and safety boards
Course overview
Lectures and workshops will cover the understanding and application of modern approaches and understanding of regulatory requirements for carrying out clinical research, including the latest requirements for IMPD preparation and good distribution practice, ethical and regulatory approval, clinical trials with medical devices and ISO14155, good clinical practice standards, preparation of clinical trial reports, the more demanding requirements of pharmacovigilance and also the legal aspects relevant to clinical trials such as data protection, insurance and codes of practice.
The use of case studies and workshops will assist in the achievement of these learning outcomes and enable the students to contextualise their understanding and knowledge.
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.
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.
Click here to check and validate your VAT number.
For EU countries; if you are unsure of the VAT number, click here to check and validate your VAT number.
Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.