Aims

The module will cover the preclinical and clinical ethics, techniques and data analysis used in drug development in the UK. Students will gain an insight into the workings of the pharmaceutical industry learning about current and future trends in analytical techniques, the use of laboratory animals and the regulatory aspects of the sector. The module will also provide students with the ethical skills necessary for the humane use of animals and humans in biomedical research.

Outline Of Syllabus

The module comprises of lectures by leading experts from the pharmaceutical industry and academics with experience of drug development/ translational pharmacology.

Topics covered will include:
-       Separation techniques (Chromatographic and non-chromatographic).
-       Animal models and in vivo techniques used in pre-clinical development.
-       Ethical considerations in both pre-clinical and clinical drug development.
-       Regulatory toxicology.
-       Clinical trial methodologies.
-       Critical evaluation of pre-clinical/clinical trial data.
-       Pharmaco-vigilance and risk management.
-       Role of regulatory bodies in clinical pharmacology and drug development.

Teaching Rationale And Relationship

The lectures and online self-paced training course provide the students with the basic theoretical knowledge and information to support the learning outcomes of the modules.

The Research Animal Training Q&A session and CBC tour will provide students with the opportunity to check their understanding of the self-paced learning with experts and will support students who wish to consider in vivo research in the future with an understanding of the Home Office PIL Certificate application process.

The seminars will allow the students to apply their theoretical knowledge focusing specifically on the four elements of the module; ethics, techniques, regulations and data analysis. This will provide an opportunity to complete some case study based problem solving activities. Seminars will also provide the opportunity for students to work in teams to interpret data and literature which will support the individual drug evaluation report at the end of the module (summative assessment).

Assessment Rationale And Relationship

The drug evaluation will be used to assess independent learning, information retrieval and critical analysis skills as well as computer literacy and the ability to appropriately justify drug development recommendations.

The case study response will provide evidence of knowledge acquisition, problem solving and evidence-formed reasoning.

In order to demonstrate the required competence levels and provide evidence of professional and practical skills development to be awarded the Home Office PIL certificate students will complete a formative MCQ assessment.


FMS Schools offering Semester One modules available as ‘Study Abroad’ will, where required, provide an alternative assessment time for examinations that take place after the Winter vacation. Coursework with submission dates after the Winter vacation will either be submitted at an earlier date or at the same time remotely. The assessment format will not normally vary from the original to ensure learning outcomes are met. Any changes to the original format must meet module learning outcomes and be approved by the school.