Life Sciences & Medicine
Continuing Professional Development (CPD)
Available course dates:
To be confirmed
*Please note that applicants to this short course should go via King's Apply (click red 'Apply' button on the right of this page) and select the following programme*:
Pharmaceutical Medicine Non-Award (Part-time)
Module code 7BBP0007
This module explores the general principles that underpin the regulation of medicines focusing on UK and EU legislation and practice.
Over five days, we will consider the core regulatory issues from product life cycle management through to marketing. The mornings are devoted to lectures and the afternoons to workshops.
Key topics include: European regulatory procedures, regulatory science, pharmacovigilance obligations and crisis management; regulatory requirements for children, the elderly, rare diseases and orphan drugs, advertising, medical aspects of the marketing authorisation, bioequivalence and generics, special licensing issues that arise for biologicals and drug-devices combinations.
In the workshops, you will work in groups to develop an efficient and optimal regulatory compliant development programme for a novel chemical medicinal product. The workshops map onto the European regulatory framework on the themes of routes to market; special considerations and the life cycle. You will build on the knowledge gained from the lectures, pre-reading and your own personal experience. There is opportunity for Q&A with the lecturers, for example, on emerging issues and concepts.
All lecturers are industry or regulatory agency practitioners.
What does this course cover?
- To give students a working understanding of the fundamental principles of the regulation of medicines and to enable them to apply these principles to regulatory activities arising in both the domestic and international arena and also in ‘grey-area’ situations.
- To provide a working understanding of how drug regulation influences the lifecycle of medicines e.g. commercialisation, pharmacovigilance and the access of special patient populations to medicines.
What will I achieve?
- To identify guidelines and legislations applicable to specific regulatory tasks associated with the medicine lifecycle e.g. the EU authorisation procedures.
- To recognise the responsibilities of sponsors and regulators arising from the regulations and to be able to enact in-house solutions to meet these responsibilities.
- To apply their fundamental knowledge of the regulation of medicines to create and/or review key documents e.g. the clinical trial application, the marketing authorisation application, the patient information leaflet; plans for quality assurance activities and plans for widening and restricting access to medicines through licence changes.
Who is this for?
Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject.
The module is suitable for industry physicians, medical affairs and regulatory affairs personnel.