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Event Details


GCP and Clinical Research Update - Hot Inspection Topics

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Who should attend?

The course is of particular relevance for those working in clinical research, regulatory affairs and pharmacovigilance as well as other professionals in pharmaceutical, biotechnology CRO, vendor/CRO companies, Regulatory Authorities and study sites, including investigator initiated studies involved in clinical trials. It will also be of interest to those departments who liaise / support clinical trial personnel and all other professionals who want to know more about updates in GCP regulations and guidelines covering clinical trials.


Course overview

Clinical research is a constantly evolving eld and the regulatory requirements are regularly being updated. In order to stay up to date and maintain your GCP knowledge it is important to receive regular training

This course provides an update on recent changes to relevant legislation and guidance and will discuss how these changes have been implemented Topics covered will include ICH GCP R2, the EU Clinical Trial Regulation, Data Integrity and the impact of GDPR on clinical trials. The programme will discuss inspection ndings and common failings in these new areas and how these should be addressed

This is a highly interactive course suitable for those who need to update their knowledge and to demonstrate recent and up-to-date training to regulatory inspectors




Leigh White

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