In 2008, the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK (FPM) established a 2-year training programme and qualification called the Diploma in Human Pharmacology (DHP). The DHP is intended for medical doctors training to take on the responsibilities of a principal investigator (PI) for human pharmacology studies of investigational medicinal products (IMPs).
The Faculty of Pharmaceutical Medicine also offers the Certificate in Human Pharmacology (CHP) - a 1-year part-time programme for doctors and scientists to attain and demonstrate a comprehensive knowledge of all aspects (design, monitoring, analysis, reporting, safety, ethics, regulation and law) of exploratory studies of IMPs in man.
Diploma in Human Pharmacology (DHP)
The DHP comprises supervised, structured workplace training with production of a portfolio of completed work and evidence of appropriate clinical and investigator skills. In addition trainees are required to attend three courses. These cover exploratory development of IMPs including 'First-in-Man' studies, principles of pharmacology at an advanced level and management of adverse events in Phase I studies. At the end of the period of training, there is a two-part examination, comprising three written papers. This document describes the objectives, eligibility criteria, curriculum and syllabus of the DHP.
The overall purpose of the DHP programme is to enable trainees to attain and demonstrate competence to serve as a PI for human pharmacology studies of IMPs, in particular those involving the first administration to humans. Such studies include those conducted in healthy and patient volunteers, in which the primary end-points are tolerability, pharmacokinetics and evidence of drug effects on biomarkers of efficacy and safety. The training in practical aspects of working as a PI is underpinned by a knowledge of the scientific basis of drug action.
The FPM has no authority to make the DHP a prerequisite for serving as a PI and the qualification cannot be considered as formal evidence of 'fitness to practise'. It also does not imply that an individual is sufficiently experienced or has all the appropriate skills to serve as a Medical Director. However, the Diploma is now recognised by the Medicines and Healthcare products Regulatory Agency (MHRA) as the most appropriate qualification for accreditation of PIs in the pharmaceutical industry. Furthermore, it is hoped that high calibre doctors working in experimental medicine, translational medicine and clinical pharmacology in academia will also wish to study for the DHP as it will provide them with particular skills and competencies of direct relevance to the conduct of their research in humans.
For more information on the DHP and to enrol on the programme please click here.
Certificate in Human Pharmacology (CHP)
The Certificate in Human Pharmacology is a 1-year part-time programme for doctors and scientists to attain and demonstrate a comprehensive knowledge of all aspects (design, monitoring, analysis, reporting, safety, ethics, regulation and law) of exploratory studies of IMPs in man.
For more information on the CHP and to enrol please click here.