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Diploma in Human Pharmacology

Diploma in
Human
Pharmacology

 

Overview

The Faculty of Pharmaceutical Medicine (FPM) runs a 2-year training programme and qualification called the Diploma in Human Pharmacology (DHP). 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 comprises 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. These cover exploratory drug development including 'first-in-human' studies (5 days), drug development pharmacology (5 days) at an advanced level and management of adverse events in Phase I studies (1 day). The two 5-day courses are run at King's College London.  In addition to post-course tests and assignments, there is also a DHP examination administered by FPM (see below).

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

Eligibilty

Further information on the course programme plus information on eligibiliy is included in the Candidate Guide and Syllabus.

 

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 CHP 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

Initial application for the DHP requires submission the completed CV template to FPM's Examinations and Standards Manager exams@fpm.org.uk. The CV will be reviewed for eligibility and if provisionally approved you will be sent an enrolment pack. Please see attached document summarising the enrolment process.

 

Exam registration (for enrolled candidates only)

The 2020 examinations will be held on 30 and 31 March 2020 at the Faculty of Pharmaceutical Medicine in Islington, London. The exams takes place once a year in February/March. Registration for the 2020 exams will open in mid January 2020.

 

Candiate Guides and Regulations

To download further details about the examinations, see the links below:

Candidate Guide and Syllabus 
Examination Handbook: Regulations and Procedures
Reasonable Adjustment Policy
Examination Appeal Procedure