The Faculty of Pharmaceutical Medicine and Diploma in Pharmaceutical Medicine Exam Dr Steve Pawsey Chairman, Board of Ex

1. The Faculty of Pharmaceutical Medicine and Diploma in Pharmaceutical Medicine Exam Dr Steve Pawsey Chairman, Board of Examiners Development Director & Chief Medical Officer Vernalis (R&D) Ltd September 2012

2. Overview • What is pharmaceutical medicine? • What is a pharmaceutical physician • Faculty of Pharmaceutical Medicine • Pharmaceutical medicine specialty training • Diploma in Pharmaceutical Medicine • Other activities • Training in human pharmacology • Revalidation

3. What is Pharmaceutical Medicine?

4. What is pharmaceutical medicine? • Pharmaceutical Medicine is the medical / scientific discipline concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of marketing of medicines for the benefit of patients and public health • Shaped by scientific advances, changing regulatory requirements and pharmacoeconomic conditions • A defined medical specialty with • Its own Royal College (The Faculty) • syllabus, curricula, courses, qualifications • standards of competence and conduct

5. An international specialty • Listed in Schedule 2 of the European Specialist Medical Qualifications Order 1995 • Recognised as a specialty • Switzerland in 1999 • UK in 2002 • Ireland in 2005

6. What is a pharmaceutical physician? An industry doctor who: • Practices pharmaceutical medicine, and • Upholds the tenets of Good (Pharmaceutical) Medical Practice laid down by the (GMC), and http://www.fpm.org.uk/revalidation/GPMP.pdf • Has public accountability for standards of competence, care and conduct, and a responsibility for communicating these standards

7. Roles of physicians in the pharmaceutical industry Drug Safety Physician Physician Scientist Clinical Pharma-cologist Clinical Research Physician Medical Advisor NDA EIM POC Market Discovery Research Drug Development Process Learning Confirming Medical Assessor, Regulatory Consultant

8. What does the pharmaceutical physician do? • Drug candidate selection • Early studies in man • Protocol design and review and study monitoring • Regulatory affairs • Safety assessment • Interface with key clinicians • Interface with senior management • Medical support for marketing • Legal responsibilities

9. The Faculty of Pharmaceutical Medicine (FPM) of the Royal Colleges of Physicians of the UK (RCP)

10. Mission To advance the science and practice of pharmaceutical medicine by working to develop and maintain competence, ethics and integrity and the highest professional standards in the specialty for the benefit of the public • Professional membership organisation • 1,400 members • Around 35% outside of UK

11. FPM: Categories of Membership Affiliates and Associates • Affiliate • open to any interested physician • Associate (Trainee) membership • available to those enrolled in PMST (before obtaining Diploma in Pharmaceutical Medicine)

12. FPM: Categories of Membership Members and Fellows • Member • hold Dip Pharm Med (or equivalent) and • registered physician and • with appropriate clinical experience • Fellow • Members who have been on the Specialist Register for at least 2 years or • Members with at least 8 years experience who meet other criteria • Honorary categories

13. Activities of the FPM • Pharmaceutical medicine specialty training programme • Human pharmacology training • Examinations • Continuing professional development scheme • Revalidation • International • Scientific meetings and events • Ethical issues • Advocacy, reports

14. FPM STRUCTURE • Trustee Board (Governance) • Committees: • Remuneration • Appointments • Fellowship & Awards • Revalidation Steering Committee F • Education Committee • (Operational) • Subcommittees: • Board of Examiners • Trainees’ Subcommittee Advocacy Committee (Operational) Coordination Committee FPM members International Committee (Operational) • Professional Standards Committee • (Operational) • Subcommittees: • Ethical Issues Subcommittee • PMST Courses Quality Management Group Staff & Contractors (Operational)

15. Board of Examiners of the FPM • Responsible for • Diploma in Pharmaceutical Medicine • Certificate in Good Clinical Practice • Diploma/Certificate in Human Pharmacology • Quality assurance of other PMST qualifying exams

16. FPM in Europe: ‘PharmaTrain’ • IMI: a public-private partnership between the EU and EFPIA, to accelerate the discovery and development of new medicines • 23 projects (topics) • EFCPM • A consortium comprising • 25 universities • 13 learned societies (3 regulatory agencies) • 15 EFPIA companies • Other partner training organisations • Successful applicant under IMI Topic 16: pharmaceutical medicine training programme EFCPM: European Federation of Course Providers in Pharmaceutical Medicine; IMI JU: Innovative Medicines Initiative; EFPIA: European Federation of Pharmaceutical Industries and Associations

17. PharmaTrain Objectives • To provide a Europe-wide comprehensive solution to training needs of integrated drug development sciences for all professionals • To create a multi-modular programme of advanced studies leading to a postgraduate Master as well as specialist qualification and accreditation

18. Roles of the FPM in Europe • Executive Board of PharmaTrain • WP7: Leading the Examination Process: Kirsteen Donaldson • Faculty members also involved in • WP3: Harmonisation of Syllabus and Training Principles: Peter Stonier • WP8: Quality and accreditation: Dominique Dubois

19. Pharmaceutical Medicine Speciality Training PMST

20. Specialty Training • All medical specialties must demonstrate • recognised, structured training programme, which is supervised, monitored, assessed, flexible and deliverable • minimum period of specialist training • defined competitive entry criteria • defined exit criteria • competence of specialists • capable of independent practice • continuing medical education

21. Why Pharmaceutical Medicine Specialty Training? • To produce accredited pharmaceutical physicians, who are equipped with specialist knowledge and comprehensive skills and competencies to practice to the highest ethical and professional standards, for the benefit of patients and the public, in the development and maintenance of medicines PMST was previously known as Higher Medical Training (HMT)

22. PMST comprises • Entry requirements • Practical competency-based programme • Specialty knowledge base • Diploma in Pharmaceutical Medicine (DPM) or equivalent • Satisfactory outcome • Award of CCT or CESR • CCT: Certificate of Completion of Training • CESR: Certificate confirming Eligibility of Specialist Registration

23. Eligibility for PMST • (Eligible for) registration with GMC • Foundation competencies including: • Good clinical care • Maintaining good medical practice • Relationships with patients & subjects, and communication • Working with colleagues • Teaching and training • Professional behaviour and probity • Acute clinical care

24. Clinical selection criteria for PMST • In any appropriate medical specialty • Experience of acute and continuing clinical management and care • Wide experience of prescribing and monitoring the effects of medicines • Apply sound clinical knowledge and judgement • Prioritise clinical need • Maximise safety and minimise risk • Supported by evidence • appraisal, satisfactory review (e.g. RITA C), reports, outcomes (e.g. Level 1 competencies) or equivalent record of satisfactory attainment

25. Duration of clinical training • 24 months’ clinical experience • Not including foundation modules • For those qualifying before August 2005, a total of 3 years FTE post-qualification • For those qualifying after August 2005, a total of 4 years FTE post-qualification

26. Practical competency-based programme • 1 generic module • Comprises • Good pharmaceutical medical practice • Interpersonal and management skills • In-work • 6 operational modules • At least two to be completed in-work; others in-work or taught courses • Individually approved programme • Training record • Annual review of competency progression (ARCP)

27. PMST: Who is involved

28. General Medical Council • Regulator for postgraduate medical training in all specialties in the UK • setting and securing standards for specialty training leading to award of a Certificate of Completion of Training • approval of • curriculum and assessment system • all training programmes, posts and GP trainers • quality assuring and evaluating the management of specialty training • dealing promptly with concerns Role of PMETB (postgraduate medical education and training board) until April 2010

29. JRCPTB • Setting and reviewing curricula and assessment standards • Project 2010 delivered re-writes of all 30 curricula incorporating lay, service and professional perspectives, leadership competencies and health inequalities • Supporting trainees • monitoring individual ' progress • providing expertise and advice as required • making recommendations for the award of Certificate of Completion of Training (CCT) and Certificate confirming Eligibility for Specialist Registration (CESR) • Working with deaneries to deliver quality management of specialist training and provide annual specialty reports

30. Specialty Advisory Committee • Established for each medical specialty • Role • Advise the JRCPTB • Write and review the specialty training curriculum • Determine the competencies of specialists • Develop methods of performance assessments and criteria for certification • Oversee trainee assessment • Assess and ensure the quality of training and appropriate support for trainees

31. Educational supervisor • Required for HMT/PMST; recommended for all • Role • plan customised training programme to ensure all elements of syllabus covered • suggest reading material • discuss recent developments • monitor progress • provide feedback on practice examination questions

32. UK Diploma in Pharmaceutical Medicine

33. Diploma in Pharmaceutical Medicine • History • 1976 Joint RCP granted first Diploma • 1989 Joint RCP established FPM • 1994 FPM assumed responsibility for Diploma • Role • essential requirement for • demonstrating knowledge base for specialty training in pharmaceutical medicine • Membership of FPM • standalone qualification demonstrating completing a period of training and reaching a certain level of achievement

34. Eligibility for DPM • Medical registration • 2+ years in a post that provides training and practical experience in pharmaceutical medicine • Now a recommendation rather than a requirement • But remember, it’s still a requirement for PMST

35. Syllabus • FPM has adopted the PharmaTrain syllabus for the UK DPM with effect from 2012 examination • Substantially re-ordered and re-numbered • 14 sections versus previous 8 • Little change in content

36. PharmaTrain Syllabus • Discovery of Medicines • Development of Medicines: Planning • Non-Clinical Testing • Pharmaceutical Development • Exploratory Development (Molecule to Proof-of-Concept) • Confirmatory Development: Strategies • Clinical Trials • Ethics and Legal Issues • Data Management and Statistics • Regulatory Affairs • Drug Safety, Pharmacovigilance and Pharmacoepidemiology • Information, Promotion and Education • Economics of Healthcare • Therapeutics

37. PharmaTrain Syllabus Discovery of Medicines Development of Medicines: Planning Non-Clinical Testing Pharmaceutical Development Exploratory Development (Molecule to Proof-of-Concept) Confirmatory Development: Strategies Clinical Trials Ethics and Legal Issues Data Management and Statistics Regulatory Affairs Drug Safety, Pharmacovigilance and Pharmacoepidemiology Information, Promotion and Education Economics of Healthcare Therapeutics

38. ‘Old’ Syllabus for DPM • Six sections corresponding to the operational modules of specialty training • Medicines regulation • Clinical pharmacology • Statistics and data management • Clinical development • Healthcare marketplace • Drug safety and pharmacovigilance • And • Discovery of new medicines • Therapeutics

39. Format of Examination for DPM • Multiple choice question (MCQ) paper • 75 questions, each with 5 completions • Short answer question (SAQ) paper • 10 questions • Test of ability to critique a published paper • 1 paper, no choice • Over 2 days, once a year in October • Closing date for entries is usually early September!

40. Recent Changes to the DPM Examination • 2010 Critical appraisal paper changed from an oral to a written exam • 2011 Essay paper withdrawn Number of MCQs increased to 75 First sitting of the exam outside London • 2012 Time allowed for CAP paper increased to 2.5 hours

41. Future Changes to the DPM Examination • Other venues outside of London under consideration • Evaluating use of computer-based assessments

42. Passing the DPM • Planning and preparation • Sitting the examination

43. Preparation, preparation, preparation.... • Course(s) • Educational supervisor • Private study • In aggregate, should cover all elements of the syllabus • You cannot get through this exam on general medical knowledge! • You must read and revise the areas of the syllabus which relate to areas you have not worked in

44. Examination Specification

45. Examination Specification • Newly introduced in 2012 • Provides both the Board of Examiners and candidates with clear guidance on what the exam will contain • Also stipulates that the BoE will provide more detail on reasons for failure

46. Courses • Cardiff! • Others e.g., • modular courses to cover specific topics • distance learning programmes • Consider • in-house opportunities • secondment to other departments • congresses/symposia • Revision courses

47. Private study • Planning • Reading • Guidance, syllabus, regulations and procedures • The ‘Red’ Book • Important guidelines: Code of practice; ICH; FDA • Textbooks on key topics • Journals: general and specialised • critique papers • look for controversial topics • Practice past questions (examination conditions!) • Network with colleagues

48. Human Pharmacology

49. Human Pharmacology: Diploma and Certificate • Diploma • For medical doctors intending to serve as Principal Investigators for exploratory studies of investigational medicinal products in man • Tolerability, PK, effects on biomarkers of efficacy and safety • Certificate • For doctors, scientists, pharmacists, regulatory and other personnel supporting such studies • e.g. design, management, monitoring, analysis, reporting, regulation, pharmacy

50. Revalidation