How to Audit Clinical Trials

An audit to summarise is an independent evaluations of activities, processes and product quality which have become a routine element of quality management and in most sectors the process of carrying out audits is mandatory. This too is the case for the pharmaceutical industry and drug development industry, where audits of clinical trial activities have become a key part of the development process since the implementation of ICH E6 in 1997. Audits of clinical trials are usually undertaken by an independent team of specialist auditors within the company or they are generally outsourced to a third party service provider.

Why you should attend:
  • Understand and evaluate the process of how to audit Clinical Trials
  • Adopt the skills required to plan an audit including using appropriate checklists/EMEA inspection guidelines
  • Carry out audits to a high standard
  • Learn out to carry out audit interviews
  • Understand what should be included in the audit report
  • Learn how to respond to the inspection findings
Why you should attend:

He has over 25 years’ experience working within the clinical audit side of pharmaceuticals and holds 2 nationally recognised teaching qualifications in Europe.

Where and when

18th -19th November 2015, London, UK

More details

For more details on the above, please fill in the registration form. You will also receive a link to download the full agenda.

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