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GCP - The Fundamentals

This one day course is designed for newcomers to clinical research and will provide a basic overview of Good Clinical Practice regulation and processes. It will be of interest to anyone wanting information on Good Clinical Practice whether they are administrative or support staff or whether they are medically qualified and wanting to gain more information on conducting clinical trials with investigational medicinal products. This training day will focus not just on GCP regulation but on the practicalities of setting up processes and quality systems. The GCP Inspection process will also be discussed fully and findings from recent inspections will be used as examples of good and bad practice. Delegate inter-action is actively encouraged and tehre will be ample opportunity for question and discussion. Course Objectives: - To ensure that delegates have an understanding of the background and development of GCP and understand the concept as well as the regulatory framework. - To ensure delegates understand the current global regulatory environment, especially with regard to law and guidance. - To ensure delegates understand the role of the key players, investigators, sponsors, monitors and support staff and how important it is to work as a team

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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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