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.
About This Course
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 91AV as suitable for their members’ CPD.
Key Learning Objectives
On completion of this course delegates will know and understand:
Course Outline
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.
About This Course
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 91AV as suitable for their members’ CPD.
Key Learning Objectives
On completion of this course delegates will know and understand:
- Why we have medicines laws and what they seek to achieve
- European mechanisms for controlling medicinal products
- UK mechanisms for controlling medicinal products
- Similarities and differences of other countries relevant legislation e.g. Brazil, Canada, China, India, Japan and USA
- International harmonisation activities of ICH and PIC/S
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
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.
