Pharmaceutical Law and Administration

4.5

What you'll gain from this course

Meets theoretical training (UK QP Study Guide)

Face-to-face learning with industry-recognized experts

Realistic QP Decision Scenarios

Networking with peers and trainers

Pharmaceutical law and administration are key foundation knowledge requirements for all QPs. This course provides comprehensive coverage of medicinal product legislation in both the EU and UK, meets the requirements of the UK QP Study Guide and offers full coverage of EU legislation for EU QPs.

Our highly interactive training provides aspiring QPs and other pharmaceutical quality professionals with the EU and UK pharmaceutical legislation understanding needed to carry out their duties with skill, authority and compliance.

Subjects Covered

Pharmaceutical legislation in the UK and Europe, with an optional U.S. session
Regulations and guidance that govern daily working practices
Why these laws exist and how they are developed
Roles and responsibilities of regulatory agencies
The vital role of EU and UK QPs in ensuring compliance and protecting patient safety

This course is approved by the Royal Society of Chemistry and is suitable for CPD. For virtual learning, training is delivered through live instructor-led classrooms and self‑paced online modules; full details are provided following registration.

Course Outline

European and UK Medicines Legislation
Legislative frameworks in the EU and UK
EU directives and regulations for human and veterinary medicines
UK Medicines and Medical Devices Act and related regulations
Clinical trial and IMP legislation
Organisation and functions of the EMA, MHRA and VMD
EU GMP (EudraLex Volume 4) and PIC/S GMP
EU and UK marketing authorisations, CTD format and application routes
Variations to marketing authorisations
Non‑clinical data/toxicology
Importation and distribution requirements
Powers of licensing authorities and sanctions
Pharmacovigilance
Veterinary medicine differences
Manufacturing and Wholesale Authorizations
Starting material controls
Parallel imports
Controlled drugs
Other relevant legislation: U.S. law and FDA; ICH; PIC/S; medical devices and combination products

Course Tutors

The course features guest speakers, including one from the UK MHRA, and tutors 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 – With over 45 years in the pharmaceutical industry, Peter specialises in EU and U.S. pharmaceutical law and has been closely involved in regulatory discussions on GMP, including serving as the EU industry representative on the ICH Q9 working group.

David Waddington – More than 30 years’ experience in quality roles across major international pharmaceutical organisations, with deep expertise in the practical application of pharmaceutical law to manufacturing and packaging operations.

Helen Erwood – Expert in regulatory affairs. Beginning her career in 1985, she became a global director in 1993 and has run her own consultancy since 1996.

Discounts Multiple delegate discounts are available on this course. Please contact us at [email protected] for further information. NHS staff will receive an automatic discount when registering with an NHS email address.

Learning Outcomes

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

Who Should Attend

The Aspiring Qualified Person

Our training is generally considered the best available and our QPs are held in high regard in the industry.
As well as being accepted in the UK, our training courses are well known and accepted by several other 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 the 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 some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.