UK Pharmaceutical Industry Association Revises Guidelines for Phase I Trials

GMP News
26 September 2007
 

UK Pharmaceutical Industry Association Revises
Guidelines for Phase I Trials

 
Although not legally binding, the 2007 edition of the Guidelines for Phase 1 Clinical Trials gives comprehensive guidance for the development of new medicines and their use in phase 1 clinical trials. According to Professor Sir Gordon Duff, Chairman of the Expert Working Group which advised the establishment of the revision, "the 2007 edition of the ABPI Guidelines for Phase 1 Clinical Trials is science based, and is a remarkably thorough and notably clear compilation of up-to-date information and guidance on best practice".

The Association of the British Pharmaceutical Industry (APBI) guidelines go back to the early 70s and experienced some revisions over the years, taking into account new aspects like the report on research in healthy volunteers of the Royal College of Physicians (RCP).

The 49 pages of the 2007 edition cover all key points for the development, investigation and regulation of new medicines with respect to phase 1 clinical trials.
Here is an extract of the contents:

  • Overview of applicable regulations
  • Types of phase 1 trials and different IMPs
  • Risk assessment and management
  • Dosing
  • Various premises, facilities and staff
  • Training
  • Trial subjects
  • Safety
  • CTA application
  • Inspections
  • IMP manufacturing
  • Biotechnology products and Radioactive substances
  • IMP Supply
  • General study management
  • Qualified Person
  • Compensation, indemnity and insurance
  • Pharmacovigilance
  • Data management, statistics, report and publication
  • Essential documents, trial master file and archiving
  • Project management and monitoring
  • Quality management

You can find the document under following link: http://www.abpi.org.uk/publications/pdfs/phase1_guidelines.pdf

Source: Association of the British Pharmaceutical Industry
The Association of the British Pharmaceutical Industry (ABPI) is the trade association for pharmaceutical companies in the UK producing prescription medicines. The ABPI also represents companies engaged in the research and/or development of medicines for human use.
 

Hear essential aspects about the organisation and management of clinical trials, IMP distribution and things to consider during the study in the European Compliance Academy's education course

During this course, the important interfaces between GMP and GCP will be elaborated.

Hear more about the role of the Qualified Person in the field of Investigational Medicinal
Products in this year's QP Forum Pre-Conference Workshop

This conference is conducted by the European QP Association.

 
Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
 

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