The Diploma in Human Pharmacology

The Diploma in Human Pharmacology programme 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), in particular those involving the first administration to humans.

Overview

The Diploma in Human Pharmacology (DHP) is a 2-year training programme and qualification. The DHP programme 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), 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 DHP programme includes supervised, structured workplace training with production of a portfolio of completed work, reflective learning and evidence of appropriate clinical and investigator skills. In addition trainees are required to attend three courses, two of which are run by King’s College, London, and to pass the DHP exams which are administered by FPM.

DHP is recognised by the Medicines and Healthcare products Regulatory Agency (MHRA) as the most appropriate qualification for accreditation of PIs in the pharmaceutical industry and is taken into account in the MHRA accreditation of study units. DHP is aimed at doctors working in contract research organisations and also NHS doctors working in various specialities such as oncology, rheumatology, experimental medicine and clinical pharmacology, who are involved in early clinical trials of investigational medicines.

Programme structure and curriculum

Supervised workplace training

A minimum period of two years’ supervised, structured training in the workplace with evidence of attainment of defined learning objectives provided by a portfolio of completed work with reflective learning and quality assured assessments of appropriate clinical and investigator skills.
Supervision of trainees is performed by an Educational Supervisors with extensive experience of Phase I studies, accredited by the FPM. Assessments of trainee competence with attainment of learning objectives are performed by the Educational Supervisor.
The trainee is required to maintain a training record, with documented evidence of attainment of the specified learning objectives, defined in terms of knowledge, skills, attitudes and behaviours.
The trainee is required to produce a portfolio of work completed in the workplace over a minimum of two years. The portfolio should provide a comprehensive overview of work performed by the trainee with evidence of reflective learning about each study in which they have been involved. It should be reviewed and validated by the Educational Supervisor at least three times each year. At the end of the training period, the portfolio will be reviewed by members of the DHP Advisory Group.

Maintaining clinical skills

Acquisition and maintenance of up-to-date clinical skills including satisfactory completion of an Advanced Life Support or equivalent course.

Courses

Attendance at two five-day courses run at King’s College, London with satisfactory completion of post-course tests and assignments. These cover exploratory drug development including ‘first-in-human’ studies and drug development pharmacology at an advanced level.
Attendance at a one-day course on prevention and management of adverse events in Phase I studies (Managing Medical Emergencies in Human Pharmacology Studies).
Any other courses deemed necessary depending on the individual trainee’s needs.

Examination

The DHP exam is administered by FPM and comprises three written papers: a multiple-choice question paper focusing on scientific knowledge, and two papers, one multiple-choice and the other short answers, about medical and scientific responsibilities of the investigator.

Further information on the course programme is included in the DHP Candidate Guide and Syllabus (pdf).

Eligibility

Information on eligibility is included in the DHP Candidate Guide and Syllabus (pdf).

Fees

The fee for enrolling on the DHP programme is £2500 which covers administration of the programme and the examination. Fees for the teaching and materials associated with the DHP courses are charged separately by the provider, King’s College London. The fee does not include travel or accommodation expenses. A reduction of Pharmaceutical Medicine Specialty Training (PMST) fees are available for those also enrolled in the DHP.

Programme registration

You can register for the programme at any time and the first step is to submit the completed CV template (doc) to exams@fpm.org.uk. The CV will be reviewed for eligibility and if provisionally approved you will be sent an enrolment pack. The enrolment process is summarised here (doc).

Exam registration (for enrolled candidates only)

The exams scheduled for 31 March 2020 have been postponed to the Autumn. A new exam date will be announced as soon as possible. Please contact us at exams@fpm.org.uk if you have any questions.