1. Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK

2. Faculty of Pharmaceutical Medicine Trainees’ Meeting Monday 18 May 2009

3. Pharmaceutical Physicians Pharmaceutical physicians are industry / regulatory doctors who uphold the tenets of Good Medical Practice laid down by the General Medical Council. Pharmaceutical physicians work with pharmaceutical companies, medicines regulatory agencies and contract clinical research organisations. All doctors have a public accountability for standards of professional competence, care and conduct, and a responsibility for communicating these standards.

4. Pharmaceutical Medicine …is the scientific medical discipline concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of marketing of medicines for the benefit of patients and the public health. …Since 2002 a medical specialty – of the Royal Colleges of Physicians of the UK

5. PMST Pharmaceutical Medicine Specialty Training Overview of PMST Process & Organisation

6. PMST What is it & How does it work? PMST is education & training for Pharmaceutical Physicians in the specialty of Pharmaceutical Medicine –Accredited outcome: CCT & place on GMC specialist register Workplace-centred competency-based programme –4-year programme (EU minimum) Specialty knowledge + practical competencies –Diploma in Pharmaceutical Medicine (DPM) –Practical Modules: RGN, CLP, SDM, CLD, HMP, DSS –Generic Module: IPM + GPMP In Practice 2009: 209 Trainees 60 Enrolling 92 CCTs 3 CESRs In Practice 2009: 209 Trainees 60 Enrolling 92 CCTs 3 CESRs

7. How does PMST work? (Competency-Based Education & Training ) Minimum three modules in the workplace, including the Generic module Follow module curricula for in-work & course- based training within a framework of: –Regular assessments –Periodic appraisals –Annual reviews (ARCP) –Collection & presentation of authenticated & validated evidence of competencies Prepare for & pass Diploma in Pharmaceutical Medicine

8. Delivery Standards & Quality of PG Education (QA) Postgraduate Medical Education & Training Board (PMETB) Faculty Education Committee Board of Examiners JRCPTB Specialty Advisory Committee - PM Senior Specialty Adviser Site (Company, CRO, DRA) Trainees (NTNs) Educational Supervisor(s) PGDean Content Regulatory Process Standards & Quality of Pharmaceutical Medicine (QM) Standards & Quality of Practice (QC) Overview of programmes & sites Training & Education PMST Organisation & Governance

9. Eligibility for PMST GMC registered pharmaceutical physician 3 - 4 years post-qualification clinical training Person specification Faculty membership Post in Pharmaceutical Medicine Approved workplace Approved, trained Educational Supervisor CCT Route or CESR Route to completion In Practice 2009: 9/209 Trainees via CESR route In Practice 2009: 9/209 Trainees via CESR route

10. Steps to be taken to complete PMST Eligibility, Enrolment, Programme planned SSA, ES, Trainee (training team) Training Plan; meet Curriculum requirements Study for DPM (sit exam after two years in PM post) Undertake projects (workplace; job description) (Supplementary) Module / Item courses Assessment, appraisal, evidence portfolio ARCP (Annual Review of Competence Progression) CCT after 4-8 years In Practice 2009: Tip: Sit DPM asap & continue each sitting until Pass. DPM a critical progress factor in PMST. In Practice 2009: Tip: Sit DPM asap & continue each sitting until Pass. DPM a critical progress factor in PMST.

11. Balance in-work & external training Workplace-centred In-Work: minimum two Subject Modules (any combination) + Generic Module External Module courses available –Four maximum in any PMST programme –FPM approved, Quality Managed, Interactive –One Course Provider per Module; frequency once a year In Practice 2009: - usual is 1- 2 external Module courses - 15-20% trainees complete CCT all in-work In Practice 2009: - usual is 1- 2 external Module courses - 15-20% trainees complete CCT all in-work

12. Prior training Exemption: One subject Module only –Qualification: e.g. MSc Clin Pharm or Stats & DM –Evidence from whole Module curriculum Prior training: Items of Modules – Bridging : prior training/activity linked to contemporary product development / commercialisation activity – Evidence : need to have evidence of competency for any prior training claimed In Practice 2009: - Very few Module Exemptions claimed. - Substantial Prior training claimed & permitted by PMETB In Practice 2009: - Very few Module Exemptions claimed. - Substantial Prior training claimed & permitted by PMETB

13. COMPETENCY ‘The ability of an individual to show that s/he has the knowledge, skills and behaviours to be able to do the task or project in question’ PERFORMANCE ‘The ability of the individual, alone or as part of a team, to apply the competencies in the real-life conduct of tasks or projects’ Assessment –by ES, experts, others –Validated tools (e.g. in-work competency; exams), Outcomes, course Assignments, MSF Appraisal –Educational (formative, developmental) –Annual performance (achievement & progress) Evidence –Filed by Module & Item (summarised, cross-referenced) –2-3 pieces per Item (reports, records, documents, emails) Sampled; abbreviated (e.g. front pages of documents) –Authenticated (personalised; reflective commentary) –Validated (by ES; ‘the evidence is what it is claimed to be’) Demonstration & Proof of Competency In Practice 2009: Evidence collection & presentation processes are critical success factor in PMST In Practice 2009: Evidence collection & presentation processes are critical success factor in PMST

14. Revalidation (relicensure & recertification) Recertification will involve portfolio of evidence of continuing specialist practice –e.g. 1 whole module + selected Items across PMST curriculum (not yet finalised) Assessment system to be agreed Evaluative review equivalent to ARCP (mid-cycle & at recertification) Annual Appraisal

15. Where did PMST come from? 1958 AMAPI - BrAPP (Association of pharmaceutical physicians) 1973 IFAPP (International Federation of Associations) 1976 UK Diploma in Pharmaceutical Medicine 1978 Postgraduate Course in PM, Univ Cardiff 1989 Faculty of Pharmaceutical Medicine 1993 MSc in Pharmaceutical Medicine, Univ Surrey 2002 UK recognition of medical specialty of PM 2003 Higher Medical Training (HMT) (Specialist training) 2005 PG Medical Education & Training Board (PMETB) 2007 Pharmaceutical Medicine Specialty Training (PMST)

16. Why do it? Education & training in Pharmaceutical Medicine Accredited training in own medical specialty Certificate of completion of training (CCT) & Place on specialist medical register of GMC Professional & personal satisfaction Structured & quality assured learning Professional benchmarking Broadens contextual perspective of role Prevents pigeon-holing Widens career options Empowering Part of lifelong learning (cf. CPD; Revalidation)

17. Why do it? Increases Employees’ Capability Increases Employees’ Flexibility More efficient Working Lowers Risk (R&D, Safety, Regulatory) Helps Career Development Increases Employees’ Loyalty Employer’s Responsibility to Staff Public assurance of competency, care & conduct of doctors working on medicines’ development Ultimate beneficiaries – Patients & The Public Health

18. Your Commitments for PMST Investment of time, resources & choice of personal options Ensure an Educational Supervisor at all times Ensure your personal Training Record maintained Ensure a portfolio of authenticated & validated evidence Ensure ARCPs* undertaken Compliance with administration & tracking Recognise the commitment of ES, SSA, company & back-up organisations Recognise that PMST aims to meet PMETB standards and quality framework (QA,QM,QC) *ARCP=Annual Review of Competence Progression

19. Today’s meeting - Workshops 1.Preparation for the Diploma (DPM) 2.Understanding Assessment in PMST 3.Tips for Evidence of Competency and preparing for the ARCP (Annual Review of Competence Progression) 4.General Questions, Clarifications and Advice

20. ‘PMST is the specialty training programme for specialist registration with the GMC in pharmaceutical medicine’ ‘PMST is the specialty training programme for specialist registration with the GMC in pharmaceutical medicine’ Top 10 Values of PMST (2)

21. ‘PMST represents the highest professional training, in knowledge, skills and attitudes, in pharmaceutical medicine’ Top 10 Values of PMST (1)

22. ‘PMST makes training and continuing education part of the job’ Top 10 Values of PMST (7)

23. ‘PMST accredits the standards of quality and of the competency, care and conduct I bring to my work as a pharmaceutical physician’ Top 10 Values of PMST (6)

24. ‘It is important for pharmaceutical physicians, like all doctors, to be publicly accountable for their practices’ Top 10 Values of PMST (3)

25. ‘PMST is necessary to keep abreast of the rapid changes in the pharmaceutical industry and drug development’ Top 10 Values of PMST (8)

26. ‘PMST will be the basis for my continuing professional development (CPD) as a pharmaceutical physician ’ Top 10 Values of PMST (4)

27. ‘PMST broadens my horizons as a pharmaceutical physician’ Top 10 Values of PMST (9)

28. ‘PMST will help me to revalidate my licence to practise medicine’ Top 10 Values of PMST (5)

29. and Finally

30. Make good use of today!