Regulatory Control of Clinical Operations

Regulatory Control of Clinical Operations
This Masterclass is also Module 5 of the MSc and will provide you with an understanding of the practical and regulatory aspects of global clinical research, in order to offer effective advice on the regulatory issues likely to arise during clinical programmes.

:17 - 19 July 2024
Where: Online
Start Day 1: 13:00 BST  End Day 3: 15:15 BST

Also available as a face to face course, please click here for the face to face registration option

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. 

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.


The programme can be downloaded here.

Module Leader

Eva Kopecna
Eva Kopecna
Head of Global Regulatory, Pharmacovigilance and Medical Affairs, Acino International

Pierre Omnes
Executive Director, Life Sciences 


Rachel Mead, MHRA
Simon Craige, EdGe Toxicology Consulting
Beatrice Panico, MHRA
Mohamed Oubihi, Yakumed
Sarah Roberts, Scendea
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.

This course is 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



    • TOPRA MSc students: £1,545 +VAT*
    • Delegates: £1,785 +VAT*

    Discounted places

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

    • Those working for regulatory agencies, government agencies or academic institutions: £1,338.75 +VAT*
    • Those working for charities, patient groups or in full-time education: £892.50 +VAT*

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

    Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer.

    Terms and conditions

    By booking a place on this course you are agreeing to the training terms and conditions.

    17/07/2024 - 19/07/2024
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