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GCP - An Update on UK & EU Regulations

This one-day course will provide all the latest information on the responsibilities of clinical trial personnel, guide delegates through the regulations and offer practical advice on how the regulations should be put into practice. This course will focus on the overall European legislation which provides the framework for all Member States but will also concentrate on the specific requirements for conducting clinical trials in the UK, which are laid down in the four UK Statutory Instruments. This course is aimed at anyone involved in clinical trials with medicinal products who would like an update on European and UK legislation. It will also distinguish between what is law and what is guidance on GCP. By the end of this course, you will be familiar with: - the latest developments in GCP and understand the effects that the Directives have on current working practices within clinical research - the Statutory Instruments that now form the UK regulations - Ethics Committees requirements and the changes in the UK ethics review process - the additional requirements within the Directive in relation to consent, especially for ‘vulnerable groups’ and ‘Legal Representative’ - the audit/inspection process and the importance of the mandatory inspections that are now being conducted at sponsor premises and investigational sites by the Medicines and Healthcare Products Regulatory Agency (MHRA)

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About Us

Since 1987, we have been delivering quality training to the pharmaceutical, healthcare, CRO and related industries. As well as delivering technical courses supporting clinical research functions, we also offer a wide range of personal development courses to ensure that skills learnt can be applied in the workplace.

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Rostrum Training Solutions Ltd

24 Lansdowne Road
Tilehurst
Reading
Berkshire
RG30 4QU

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