Pharmaceutical Law and Administration Training
18.5hr instructor led, 12.5hr self-paced
About This Course
Pharmaceutical law and administration are key foundation knowledge requirements for all QPs. This course provides comprehensive coverage of the medicinal product legislation in both the EU and UK. The course meets the requirements of the UK QP Study Guide and also provides comprehensive coverage of EU legislation for EU QPs.
Our highly interactive, four-and-a-half-day training course provides aspiring QPs and other pharmaceutical quality professionals the EU and UK pharmaceutical legislation knowledge needed to carry out their duties with skill and authority and to ensure compliance with relevant laws.
- Pharmaceutical legislation in the UK, Europe and the U.S.
- 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 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
- An overview of U.S. legislation for controlling drug products
- International harmonization activities of ICH and PIC/S
European and United Kingdom Medicines Legislation
- The legislative frameworks in the EU and UK
- EU directives and regulations affecting medicines
- UK Medicines and Medical Devices Act and regulations affecting medicines
- Laws governing clinical trials and investigational medicinal products
- Organization and function of the EMA and MHRA
- EU GMP (EudraLex Volume 4) and PIC/S GMP
- EU and UK marketing authorisation, content, structure (CTD) and application routes
- Variations to marketing authorizations
- Non-clinical data/toxicology
- Importation and distribution into the EU and UK
- Powers of the licensing authorities and sanctions
- Differences for veterinary medicines
Manufacturing and Wholesale Authorizations
- Starting material controls
- Parallel imports
- Controlled drugs
UK Medicines Legislation
- Background and development of UK medicines legislation
- The UK Medicines and Medical Devices Act
- The roles of the MHRA and VMD
Other Relevant Legislation
- U.S. legislation and the FDA
- International Council for Harmonisation (ICH)
- Pharmaceutical Inspection Cooperation Scheme (PIC/S)
- 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 in the industry. Our training courses are accepted in the UK and 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.
The course features guest speakers, including one from the UK MHRA, and tutors are 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 45 years’ experience in the pharmaceutical industry and specializes 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 organizations, David has extensive knowledge on the practical and pragmatic application of pharmaceutical law in manufacturing and packaging operations.
Helen Erwood - Helen is an expert in regulatory affairs. She started her career in 1985, became a global director in 1993 and has run her own consultancy since 1996.
Multi-delegate discounts available. Discounts also offered to NHS staff, regulators and charities.
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