Pharmaceutical Law and Administration Training

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 training course provides aspiring QPs, and other pharmaceutical quality professionals, the EU and UK pharmaceutical legislation understanding needed to carry out their duties with skill and authority and to ensure compliance with relevant laws.

Subjects Covered

• Pharmaceutical legislation in the UK and Europe with an optional session for 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 EU and UK 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.

If you choose our virtual learning option, we will deliver training via a combination of live instructor-led virtual classrooms and self-paced online learning. We will send you full details following registration.

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 optional 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 (Human and Veterinary)
• UK Medicines and Medical Devices Act and regulations affecting medicines
• UK Medicines Legislation
• Laws governing clinical trials and investigational medicinal products
• Organization and function of the EMA, MHRA and VMD
• 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
• Pharmacovigilance
• Differences for veterinary medicines.

Manufacturing and Wholesale Authorizations

• Starting material controls
• Parallel imports
• Controlled drugs.

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.

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 Quality or 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:

Phil Butson - Fellow of the Royal Pharmaceutical Society and the RQA, Chartered Quality Professional and experienced GMP QP. With 35+ years in QA, development and clinical supply, Phil is recognised for leadership in QMS, IMPs, ATMPs and regulatory interpretation.

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 and charities.