Clinical Trials

£535 + VAT

24th September 2008

This course is aimed at people working in pharmaceutical R&D, those newly appointed to clinical research and personnel providing clinical supplies and other trial support services.

The course provides a detailed introduction into the clinical trial arena and explains the key purposes, practices and principles involved. It introduces the legislation, standards and guidelines that impact on performing such trials.

Course Content:

• What is a clinical trial?
• How clinical trials fit into the drug development process
• Trial phases (I-IV) explained
• Legislation and guidance: implementation of the Clinical Trials Directive
• Clinical Trial Authorisation
• Good Clinical Practice: GMP for trial medication including QP release
• Clinical trial design, conduct, data management and study reporting
• Documentation and record retention
• Personnel involved: sponsor, investigator, delegates, contractors
• Ethics and responsibilities
• Quality and compliance

To book a training course, please download the booking form, complete and email to bookings@rssl.com