When: 7 - 9 July 2026
Where: Online
Start Day 1: 13:00 BST End Day 3: 15:15 BST
This course is also available to take part in in-person
Suitable 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
Course information
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.
Benefits to delegates
- Students will understand the practical aspects of Good Clinical Practice and how it supports clinical research.
- Students will be able to 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.
- Students will gain an insight into the complexities and requirements of pharmacovigilance in clinical research.
- Students will be able to understand the management of clinical trial supplies.
- Students will be able to understand the requirements of Good Manufacturing Practice, authorisation and importation of investigational medicinal products.
- Students will be able to understand clinical trial reporting, the management of the data, data auditing and the practicalities of Good Clinical Practice inspections.
- Students will 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.
CPD: This course provides 15 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
The programme can be downloaded here.
Module Leader
Eva Kopecna
Head of Global Regulatory, Pharmacovigilance and Medical Affairs, Acino International
Pierre Omnes
Executive Director, Life Sciences
Speakers
Rachel Mead, MHRA
Simon Craige, EdGe Toxicology Consulting
Beatrice Panico, Scendea
Mohamed Oubihi, Yakumed
Sarah Roberts, PRAHS
Graham Bell, ICON
Neil R Armstrong, MeddiQuest Europe, North America and UK
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 |
£1,900.00 + VAT* |
Standard Price
Non-member |
£2,375.00 + VAT* |
TOPRA MSc Students
|
£1,650.00 + VAT* |
Save on the full cost of membership and £180 on the price of your training
course when you add TOPRA membership to your booking (membership fees are exempt from 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.