The Qualified Person (QP) must have a thorough knowledge and understanding of European and UK Laws related to the manufacture and distribution of medicinal products for human and veterinary use.

This course provides a comprehensive overview of the requirements of the UK Study Guide and, by using interactive questions and scenarios, shows how the Qualified Person or anyone with a responsible position within the pharmaceutical industry can keep up to date and assure compliance.

Suitability:

This is an essential course for candidates who expect to apply for their QP viva within one year. The course also provides a valuable contribution to Continuing Professional Development for existing QPs and all other managers or supervisors with responsibilities for manufacturing medicinal products.

For those not directly related to manufacturing it provides a valuable overview of the regulatory framework by which medicines are controlled.

Learning Outcomes:

At the end of the course you will know and understand:

- The UK laws and European Directives for the manufacture and distribution of medicinal products for human and veterinary use
- Clinical Trial Legislation
- Product and Site licensing in the UK and EU
- Role and structure of the EMA, MHRA & VMD
- Pharmacovigilance requirements
- The role of the pharmacopoeias and EDQM
- International harmonisation, ICH, PIC/S and Mutual Recognition Agreements

Course cost: £1390 (+VAT)