Date: 28 April 2021 (virtual course on TEAMS during the pandemic)

Time: 09.30 to 16.30 (UK BST)

This course is a suitable introduction or refresher for those involved in any aspect of clinical trials with human participants.  The detail of ICH GCP (R2) will be explained as well as the practicalities of using the regulations in the field.  Additional information will be given on GDPR, Risk Management (including Key Risk Indicators [KRIs] and Quality Tolerance Limits [QTLs]), hot topics from the regulators, and the next developments in the regulations.  There will be a short quiz at the end of the course.

The tutor is Fiona Waddell who has been involved in all aspects of clinical trials, at all levels for 40 years in academia, the NHS, and commercial organisations.  Fiona’s training style is to pepper the facts with interesting stories that will bring the regulations to life and ensure that you stay awake for the entire day!

The cost of this one-day course is £420 plus VAT for an individual and if more than 5 participants enrol from one company there is a block price of £2,500 for any number up to 15 participants.

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