QP Module Pharmaceutical Law and Administration Training

10 January 2017 09:00 - 11 January 2017 17:00, Reading, United Kingdom


Course Scope

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.

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.

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

RSSL Training

RSSL Training, Reading Enterprise Centre, Earley Gate, Whiteknights Campus, Reading, RG6 6BU, United Kingdom

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