Pharmaceutical Law & Administration
NSF International, Pharmaceutical Services
Course description
Pharmaceutical Law & Administration
This highly interactive four-and-a-half-day course is designed to provide the aspiring Qualified Person and pharmaceutical quality professional with the knowledge and understanding of international pharmaceutical legislation so that they can carry out their duties with skill and authority. We will describe the laws, regulations and guidance that dictate how we must work on a daily basis, we will explain why these laws exist and how they come into being, we will describe the roles and responsibilities of the major international regulatory agencies and we will emphasise the key role that QP and pharmaceutical professionals must play to ensure compliance with international legislation in the interest of patient safety.
Pharmaceutical law and administration is a key foundation knowledge requirement for all Qualified Persons (QP). This is clearly spelled out in the relevant article of European Directives 2001/82/EC and 2001/83/EC and in the current Qualified Person Study Guide. The QP must ensure that the relevant laws are being complied with. Thus, a thorough understanding of the laws and legal processes, within Europe and beyond, is essential.
This is equally true for other pharmaceutical technical managers.
This course is approved by the Royal Society of Chemistry as suitable for their members’ CPD.
*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.
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.
Key Learning Objectives:
- To understand why we have medicines laws and what they seek to achieve
- To understand the European mechanisms for controlling medicinal products - EU Directives and Regulations affecting human and veterinary medicines - The role of the QP - Importation into the EU and distribution within the EU (wholesale dealing) - Marketing, manufacturing and wholesale authorizations - Organization and function of EMA - Mutual recognition agreements (MRAs) - Powers of the licensing authorities and adverse licensing actions
- To understand UK mechanisms for controlling medicinal products - UK Medicines Legislation - MHRA and VMD
- To understand other relevant legislation and guidance - US legislation and the FDA - International Council for Harmonization (ICH) - PIC/S - Medical devices - Borderline products - Controlled drugs
Training Course Content
Course Outline
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 market’s legislation
- International Council for Harmonisation (ICH)
- PIC/S
- Medical devices and combination products
We provide an optional post-course assessment.
Expenses
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.
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About provider
NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...
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NSF International, Pharmaceutical Services
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