Approved training courses
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
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
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
• 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 within 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.
For any queries regarding entry requirements for both QP training and/or postgraduate qualifications please contact QPpharma@nsf.org
Additional infoNSF delivers instructor-led QP courses with blended training methods, in a mix of virtual and in-person courses. Please visit www.nsf.org/training for current dates. If you cannot see your delivery method of choice, please contact QPpharma@nsf.org
Class/lab
York
5 days
£3780.00 GBP (plus VAT)
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Courses are approved for CPD purposes only; approval does not imply they will fulfill any regulatory requirements.
