Investigational Medicinal Products

£535 + VAT

2nd December 2008

This is a 1 day course which will be of value to any pharmaceutical professional working in the areas of Quality Assurance, Quality Control, Production, R&D and Regulation who needs to have an increased knowledge and understanding of this area. This course examines the legislation and GMP issues associated with Investigational Medicinal Products.

Delegates will learn about the principles of Good Clinical and Good Laboratory Practice, especially related to producing product for clinical trials.

Course Contents:

• Principles of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)
• GMP requirements for Investigational Medicinal Products (EU GMP Annex 13)
• Regulatory requirements of clinical trial materials
• Clinical trial design
• The Clinical Trials Directive
• Special Manufacturing Licenses
• Investigational Medicinal Products and the Qualified Person

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