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Regulatory Control of Clinical Operations




Chesham, Buckinghamshire, UK


25 Nov 2020 - 27 Nov 2020

Reference No: T2006411-TOP

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Key points about this Training Event

  • 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
  • Understand the management of clinical trial supplies
Event Description

Course Outline:

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. 

When & Where?

25 - 27 November 2020

De Vere Latimer Estate


Course fee for Members: £1,700.00 plus 20% VAT
Course fee for Non-Members: £1,500.00 plus 20% VAT

Applicant Requirements
  • 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
Reference No: T2006411-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.


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