Law and Administration

£1070 + VAT

Dates for 2009 to be published shortly

This course is primarily aimed at intending and existing Qualified Persons and is based on the requirements of the QP Study Guide 2000.

It is also highly recommended to any quality or production professional who needs a greater understanding of the legal requirements surrounding the manufacture, sale and supply of medicines in the EU.

Course Content:

• The UK Medicines Act (1968) and UK Statutory Instruments
• European pharmaceutical directives including 2001/83/EC & 2001/82/EC
• The legal status of GMP in Europe
• The structure of the MHRA's Orange Guide
• Marketing Authorisations (Product Licenses)
• Manufacturing Authorisations (Manufacturing Licenses)
• Labelling regulations
• Other relevant legislation
• The Clinical Trials directive
• Pharmacopoeias
• The organisation of the UK's Medicines and Healthcare products Regulatory Agency (MHRA)
• Mutual Recognition Agreements

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