Course description
Pharmaceutical Law & Administration - QP Module
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.
Subjects Covered
- 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.
Suitability - 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 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 within 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.
Outcome / Qualification etc.
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
Training Course Content
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
- Pharmacovigilance
- UK Medicines Legislation
- Manufacturing and Wholesale Authorisation
- Starting material controls
- Parallel imports
- Controlled drugs
UK Medicines Legislation
- Background and development of UK medicines legislation
- MHRA and VMD
Other Relevant Legislation
- US legislation and FDA
- Other major markets legislation
- International Council for Harmonisation (ICH)
- PIC/S
- Medical devices and combination products
We provide an optional post-course assessment.
Course delivery details
If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.
All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Reviews
Average rating 5
The gold standard of training, very interactive and informative, thanks.
Thought the pace of the tutors providing the lectures was excellent and their knowledge and openness has made the learning element effective.
Expenses
Discounts
Multiple participant discounts available. Discounts also offered to NHS staff, regulators and charities.
Really enjoyed everything about this course. All the lecturers are so lovely, friendly, easy to listen to, funny and so knowledgeable. The course is perfectly broken down into m...