PharmaSchool: EU Directives on Clinical Research

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: GGL003

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Duration: 1 day

Description:

This course provides an overview of European clinical trials legislation and guidance along with some advice on practical application of the requirements.

Who it is suitable for:

The course is aimed at clinical operations staff conducting clinical trials in the EU, for example, Project Managers, CRAs, CTAs. It is also suitable for those who need specific information regarding EU GCP requirements, for example, senior managers, auditors, pharmacovigilance staff, medical writers, etc.

Example content:

Background and History of Clinical Research Legislation in Europe

The development of European clinical trial legislation
European regulatory and advisory bodies

Eudralex Vol 10 - Clinical Trials

Structure
Contents

The Clinical Trials Directive (2001/20/EC)

Structure
Contents
Workshop session on implications

The GCP Directive (2005/28/EC)

Structure
Contents
Workshop session on implications

The GMP Directive (2003/94/EC)

Structure
Contents
Workshop session on implications

The Paediatric Regulations (1901/2006 and 1902/2006)

Structure
Contents

Customised In-house Courses are designed for organisations wishing
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Previous Course Feedback: EU Directives on Clinical Research
Customer: Pharma Company
Number of Participants: 15
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Rate the course overall on the scale 10: Excellent, 0: Poor
Average score: 9.8
Participant Feedback :
The course made me aware of what I needed to know
Made the subject really interested and practical
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