Pharmaceutical Law and Administration Training
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 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, Europe and the US
- 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 quality 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.
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 US legislation for controlling drug products
- International harmonization activities of ICH and PIC/S
Course Outline
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
- Pharmacovigilance
- Differences for veterinary medicines
Manufacturing and Wholesale Authorizations
- Starting material controls
- Mutual recognition of inspection agreements (MRAs)
- Parallel imports
- Controlled drugs
UK Medicines Legislation
- Background and development of UK medicines legislation
- The UK Medicines and Medical Devices Act and Statutory Instruments
- The roles of the MHRA and VMD
Other Relevant Legislation
- US 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 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.
Course Tutors
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.
Discounts
Multi-delegate discounts available. Discounts also offered to NHS staff and charities.
Qualified Person Training With NSF International
Watch the video
Pharmaceutical Legislation Update
Regulatory Affairs for QA: Variations
Regulatory Affairs for QA: Marketing Authorizations
Additional Recommended Courses
The Role and Professional Duties of the Qualified Person
This intensive, interactive training course is designed to provide aspiring QPs and other pharmaceutical quality professionals with the knowledge and understanding they need of the legal duties of the QP and, more importantly, how the QP must work with others to ensure that those duties and responsibilities are performed in the best interests of the company, the patient and society.
This course will help you to understand what the QP must do themselves and what can/must be delegated to others, it will provide advice on how the QP should work in tandem with professionals in other departments, and will stress the non-technical “people” skills that are essential to being a good QP.
Tutors: To be confirmed
Price: £2520 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff are entitled to a 50% discount. (Proof will be required).
Mathematics and Statistics
There are many training courses on statistics and statistical analysis, but very few which focus specifically on the application of these techniques to pharmaceutical manufacture and control. This is one such course! Designed to meet the needs of the aspiring Qualified Person and other pharmaceutical professionals and taught by a combination of statisticians and pharmaceutical industry professionals, this highly participative four-day mathematics and statistics pharmaceutical training course will teach you how to use statistical techniques to assess and monitor the reliability and accuracy of data you generate and the capability and reliability of the processes you work with. A pharmaceutical statistics course like no other! This virtual blended training course will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. This will require an element of learning to be completed prior to the virtual classroom, as well as afterwards and this will be managed through our online Learning Management System. Full details, including timings for the instructor-led virtual classrooms, will be emailed following registration.
Tutors: To be confirmed
Price: £3160 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff are entitled to a 50% discount. (Proof will be required).
Pharmaceutical Microbiology
A highly interactive pharmaceutical microbiology training course, designed to provide you as an aspiring Qualified Person and pharmaceutical quality professional with the knowledge and understanding you need to: assess microbiological risks in the pharmaceutical manufacturing environment, assist in the design and implementation of comprehensive microbiological control strategies, and also so take informed decisions when microbiological problems occur.
Tutors: To be confirmed
Price: £3160 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course. The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities and NHS staff are entitled to a 50% discount. (Proof will be required).