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Clinical Trial Regulatory Requirements


£1,299 *


London, United Kingdom


09 Jul 2018 - 10 Jul 2018

Reference No: M1802265-MAF

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Key points about this Training Event

  • Decipher the framework of clinical trial regulations and guidelines in Europe
  • Gain an update on the new EU Clinical Trial Regulation and the recently finalised ICH GCP R2 Guideline
  • Discuss the impact of Brexit
  • Understand clinical trial authorisations: regulatory and ethical approval n Realise the most important legal aspects of clinical trials
  • Ensure you comply with pharmacovigilance and adverse event reporting
  • Make certain you are prepared for regulatory inspections
Event Description

Course Outline:

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation, the new ICH GCP (R2) guideline and existing Directive requirements. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.

Key topics to be covered include:

  • The current requirements of the EU Clinical Trial Directive
  • The EU Clinical Trial Regulation (536/2014)
  • The impact of Brexit
  • Clinical trial authorisations
  • Complexities for running paediatric trials
  • Requirements for managing investigational medicinal products
  • Legal aspects of clinical trials
  • Requirements of pharmacovigilance
  • New ICH GCP R2 guideline requirements
  • Regulatory inspection

When & Where?

9 July 2018 - 10 July 2018

Rembrandt Hotel


GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,339 2,027 *

* When you book before 18 May 2018
GBP price exclues VAT @20%

Applicant Requirements
  • Anyone requiring an overview or refresher of the current clinical trial regulatory and guideline requirements and an update on the new EU Clinical Trial Regulation
  • Those working in regulatory, clinical research, clinical operations, project management, quality assurance (GCP auditors), vendor /CRO professionals, study sites
  • Professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products
  • Departments who liaise / support clinical trial personnel (such as clinical trial supply, pharmacovigilance, quality assurance, document management, legal and regulatory authorities
Reference No: M1802265-MAF
For over 30 years Management Forum has been an internationally renowned independent training company which organises professional conferences, seminars and in-house courses for the Life Science and Intellectual Property sectors.


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