Approved training courses

Course description

Please note, the duration of this course is 4.5 days.

Pharmaceutical law and administration is a key foundation knowledge requirement for all Qualified Persons (QPs). This is clearly spelled out in the relevant article of European Directives 2001/82/EC and 2001/83/EC and in the current Qualified Person Study Guide. The QP must ensure that the relevant laws are being complied with. Thus, a thorough understanding of the laws and legal processes, within Europe and beyond, is essential. This is equally true for other pharmaceutical technical managers.

This extremely popular module is designed to ensure that, in an increasingly changing world, you have a deep and detailed understanding of:
• Why we have medicines laws and what they seek to achieve
• The laws and legislative processes within the EU which impact on medicinal products, and hence the role of the QP
• The UK medicines legislative framework
• US and other international pharmaceutical legislation
• Other relevant laws and guidelines

COURSE OUTLINE

European Medicines Legislation
• The legislative framework in the EU
• EU Directives affecting medicines
• Organization and function of EMA
• Rules governing medicinal products in the EU (EudraLex)
• Importation into the EU and distribution within the EU (wholesale dealing)
• Powers of the licensing authorities and adverse licensing reports
• Pharmacovigilance
UK Medicines Legislation
• Background and development of UK medicines legislation
• MHRA and VMD
Other Relevant Legislation
• US legislation and FDA
• International Conference on Harmonization (ICH)
• PIC/S
• Medical Devices

Pre-requisites

Please speak to Aimee Harding, QP Administrator at NSF about entry requirements for both QP training and/or postgraduate qualifications.

Additional info

Lunches and refreshments are included in the course fee plus a special 'course dinner' on the penultimate evening. Specially negotiated B&B rates are available. For further information please contact Aimee Harding, QP Administrator at NSF.

Venue

Marriott Hotel

Teaching method

In-house

City

York

Duration

5 day

Cost

£3330.00 GBP (plus VAT)

Training provider

NSF International

Email

qppharma@nsf.org

Tel

01751432999

Find an approved training course

Use the options below to search through the growing list of chemical sciences training courses that have been approved by the Royal Society of Chemistry.


Blended Learning
Class/lab
In-house
Online