UK Statutory Instrument

Good Clinical Practice UK Law and Legislation – Now Available

Accredited with 10 ICR* CPD points.

Any organisation conducting clinical trials in the United Kingdom has to be familiar with local law and not assume that it is the same as the EU Directive. This course gives an insight into the important requirements of UK Law. It describes in simplified terms how UK Clinical Trials legislation puts the EU Directives 2001/20/EC and 2005/28/EC into UK Law.

This course is suitable for anyone involved in the set up, reporting or conduct of a clinical trial in the UK.

It has 4 sections covering the following topics:

• UK Clinical Trials Legislation – Major changes
• UK Clinical Trials Legislation – Parts 1 to 3
  • Introductory provisions
  • Ethics committees
  • Authorisation for clinical trials and ethics committee opinion
• UK Clinical Trials Legislation – Parts 4 to 6
  • Good clinical practice and the conduct of clinical trials
  • Pharmacovigilance
  • Manufacture and importation of investigational medicinal products
• UK Clinical Trials Legislation – Parts 7 to 9
  • Labelling of investigational medical products
  • Enforcement and related provisions
  • Miscellaneous provisions

To purchase this course click here Purchase

* Institute of Clinical Research