About This Course
Pharmaceutical law and administration are key foundation knowledge requirements for all 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. Our highly interactive, four-and-a-half-day training course is designed to provide aspiring QPs and pharmaceutical quality professionals with the understanding of international pharmaceutical legislation that is needed to carry out their duties with skill and authority.
Beyond understanding, the QP and other pharmaceutical technical managers must ensure that the relevant laws are being complied with. Thus, a thorough understanding of the laws and legal processes, within the UK, Europe and beyond, is essential.
- Pharmaceutical legislation
- Regulations and guidance that dictate how we must work on a daily basis
- Why these laws exist and how they come into being
- Roles and responsibilities of the major international regulatory agencies
- The key role that QPs and pharmaceutical professionals must play to ensure compliance with international legislation in the interest of patient safety
This course is approved by the Royal Society of Chemistry and is suitable for its members’ continuing professional development.
Key Learning Objectives
On completion of this course, delegates will know and understand:
- Why we have medicines laws and what they seek to achieve
- UK mechanisms for controlling medicinal products
- European mechanisms for controlling medicinal products
- Similarities and differences in other countries’ relevant legislation, e.g. Brazil, Canada, China, India, Japan and the USA
- International harmonisation activities of ICH and PIC/S
European Medicines Legislation
- The legislative framework in the EU
- EU directives and regulations affecting medicines
- Laws governing clinical trials and investigational medicinal products
- Organisation and function of EMA
- EU GMP (EudraLex Volume 4)
- EU marketing authorisation, content, structure (CTD) and application routes
- Variations to marketing authorisations
- Non-clinical data/toxicology
- Importation into the EU and distribution within the EU
- Powers of the licensing authorities and sanctions that can be imposed
Manufacturing and Wholesale Authorisations
- Starting material controls
- Parallel imports
- Controlled drugs
UK Medicines Legislation
- Background and development of UK medicines legislation
- MHRA and VMD
- Current expectations for the UK leaving the EU
Other Relevant Legislation
- U.S. legislation and the FDA
- Other major markets’ legislation
- International Council for Harmonisation (ICH)
- Medical devices and combination products
Who Should Attend
The Aspiring Qualified Person
Our training is generally considered as the best available and our QPs are held in high regard within the industry. As well as being accepted in the UK, our training courses are accepted by several EU countries including Ireland, the Netherlands, Austria, Hungary and Malta. You are more likely to become a QP with us than with any other training provider.
The Pharmaceutical Technical Professional
Not all people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control. Many industry professionals, from a range of disciplines, attend the courses as part of their continuing professional development. Taken with our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.
Course tutors will be selected from the following:
Rachel Carmichael - Rachel is a former UK MHRA GMP Inspector. She has extensive knowledge of pharmaceutical law and its practical implementation.
Peter Gough - Peter has over 40 years’ experience in the pharmaceutical industry and specialises in EU and U.S. pharmaceutical law. He has had direct involvement in discussions with regulators on quality and GMP, having been the EU industry leader on the ICH Q9 working group.
David Waddington - With over 30 years’ experience in various quality roles for three major international pharmaceutical organisations, David has extensive knowledge on the practical and pragmatic application of pharmaceutical law in manufacturing and packaging operations.
Plus, guest speakers including one from the UK MHRA
Course cost (excluding VAT) £3,230.00
Multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities– contact us for details.
Have a question or want to book a place? Contact email@example.com
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