Council for Education in Pharmaceutical Medicine (CEPM) POSTGRADUATE COURSES IN PHARMACEUTICAL MEDICINE IN EUROPE

Transcription

1 International Federation of Associations of Pharmaceutical Physicians founded 1975 POSTGRADUATE COURSES IN PHARMACEUTICAL MEDICINE IN EUROPE October 2008 Council for Education in Pharmaceutical Medicine (CEPM)

2 CONTENTS Page Belgium 3 France 7 Ireland (Hibernia College) 10 Ireland (Trinity College) 14 Serbia 18 Spain (Barcelona) 21 Spain (Madrid) 24 Sweden 27 Switzerland 30 United Kingdom (Cardiff, Wales) 33 United Kingdom (Guildford, Surrey) 36 Database Courses in PM Page 2 of 33

3 BELGIUM 1. Title of Course: Postgraduate programme in Pharmacology and Pharmaceutical Medicine (PHARMED) 2. Main University organising the Course: ULB ( Free University of Brussels) 3. Address of Secretariat of Course: PHARMED Free University of Brussels Attention Mrs B. JELLOULI Building GE, CP611 Route de Lennik, 808 B-1070 Brussels Belgium Telephone number: Fax number: address: pharmed@ulb.ac.be Web site (if available): Course Director: Course Administrator: Prof. Jean-Marie Boeynaems Mrs B. Jellouli 4. Year of Foundation of the Course: 1992 Course language: English 5. Seminars/Modules: How many seminars/modules does the full course contain?: 8 What is the duration of each seminar/module (in days)?: 4 days (from Monday noon to Friday noon) What is the frequency of the seminars/modules?: 1 per month from October till June (except December) Are the seminars/modules distributed over 1 or 2 years?: optional (1 or 2 years) How many hours of teaching does the full course contain?: 260 hours How is this distributed over : Seminars (didactic lectures): 80% Workshops: 20% Group discussions: yes (discussion of homeworks) Other (please specify): none Is distance learning or home work scheduled in the course? yes (homeworks) Is the course taught (please circle right answer) All in one place Rotating to several places in the same city, in the same country or in several countries? Does the programme cover all items mentioned in the Syllabus of yes The Faculty of Pharmaceutical Medicine (London)? (see document enclosed): If not, please comment: Database Courses in PM Page 3 of 33

4 6. Time: How many hours are spent on teaching of Clinical Research? How many hours are spent on teaching Regulatory Affairs?: How many hours are spent on teaching Pharmacovigilance? How may hours are spent on teaching Statistics?: How many hours are spent on teaching Pharmaco-Economics? How many hours are spent teaching Marketing & Business matters? 57 hours 20 hours 7 hours 18 hours 10 hours 35 hours 7. Teachers: How many teachers are participating in the programme? : 71 teachers How many are from Industry?: 21 How many are from CROs?: 22 How many are from Academia?: 21 How many are from Regulatory Authority?: 4 How many are from other organisations? (please specify): 2 (patent office) 8. Course material: Is course material (please circle right answer) paper-based electronic based Is course material prepared by teachers individually? If no, please specify who is responsible both yes no 9. Students: What is the average number of students registering each year: To the full course? 25 To individual seminars?: 20 To the examinations?: 12 What are the requirements to register for the course and the examinations (please circle right answer): Physicians only: Physicians and PhDs and MScs in biosciences (veterinary, pharmacists, biologists, ): Physicians and PhDs in biosciences and others(please specify): What is the usual ratio physicians versus non-physicians?: 70% / 30% 10. Examinations: Are examinations conducted (please circle right answer) Twice a year Other frequency (please state). Once a year Are the examinations (please circle right answer) Both written and oral Written only Oral only Does the written examination include (please circle right answers): Multiple Choice Questions (MCQs): yes no If yes, how many MCQs are asked at each session?: 30 Database Courses in PM Page 4 of 33

5 In the choices given is only one correct or several ones? Short questions?: Short dissertations? Only one Several yes no yes no Who writes and updates the MCQs? (please circle right answer) Each teacher individually with supervision of a specific Committee What is the duration (in minutes or hours) of The written examination?: The oral examination?: Is attendance to the courses compulsory for sitting the examination : If yes, how much of the course must be completed (in percentage)?; Are there any assessments during the course? 2 hours 45 minutes per candidate no no 11. Recognition: Do you want your course recognised by (please circle the right answer) Your National Health Authorities no Your National Academy of Medicine no The Faculty of Pharmaceutical Medicine yes Your Regulatory Authorities no Employers no Is your course already recognised by any of these organisations or others? Please comment: yes, by the Royal Academies of Medicine of Belgium and the Faculty of Pharmaceutical Medicine (with mutual recognition of diplomas) 12. Fees (please reply in Euros or Pounds ): What is the fee to be paid for attendance to The full course?: Per module/seminar?: The examination?: Is a fee requested when awarding the diploma? 5000 euros 900 euros 200 euros (for candidates who have followed the course) 500 euros for independent candidates no SUMMARY This is a non-residential course consisting of eight modules. All modules are taught every year, but the students have the choice between attending all modules in one year or spreading the attendance over 2 or 3 years. Each module takes one full week of every month from November till June leading to a total of 260 hours of teaching at the Université Libre de Bruxelles (ULB). An average of 45 students are registering every year either to the full course or individual modules. The courses are taught by 71 lecturers of which 43 are from Industry. Both physicians and PhDs in Life Sciences are accepted. The ratio of physicians to non- Database Courses in PM Page 5 of 33

6 physicians is 70% vs 30%. Physicians passing the examination are awarded a Diploma in Pharmaceutical Medicine recognized by the Belgian Royal Academies of Medicine and the Faculty of Pharmaceutical Medicine (London). Holders of this Diploma are entitled to apply for membership of the Faculty without having to pass the examinations in London and to be registered on the Register of Physician Specialists in Pharmaceutical Medicine after at least two years of full time practice of pharmaceutical medicine. This register is held by the Belgian College of Pharmaceutical Medicine composed of members of the Royal Academies of Medicine and members of the Belgian Association of Pharmaceutical Physicians. Oral and written examinations are organized at least one a year. It is not required to follow the courses to register for the examination, provided the candidate is a graduate and has an adequate experience in pharmaceutical medicine. The fee for the full course is 5000 euros. Database Courses in PM Page 6 of 33

7 FRANCE 1. Title of the Course: EUDIPHARM (European Diploma in Pharmaceutical Medicine) 2. Main University organising the Course: Claude Bernard University, Lyon 1 3. Address of Secretariat of Course: EUDIPHARM Attention: Mrs Haleh Vignon Faculté RTH Laennec Rue Guillaume Paradin BP8071 F Lyon cedex 08 France Telephone number: Fax number: address: hv@upcl.univ-lyon1.fr Web site: Course Director: Course Administration: Prof. Jean-Pierre Boissel Mrs. Haleh Vignon 4. Year of Foundation of the Course: 1999 Language of the Course: English 5. Seminars/Modules: 1 st year: one basic Module made of 18 sub-modules, each of 2-3 days duration; 2 nd year: 16 specialized Modules (of which the students must chose at least 4) Duration of each Seminar/Module: 1 st year: basic Module : 46 days (3 x 3 weeks) 2 nd year: each specialized Module takes 2 weeks The frequency of the Seminars/Modules is variable. The Seminars/Modules are distributed over 2 years. Hours of teaching of the full course: 325 hours Distribution: Seminars (didactic lectures): 70% Workshops: 10% Group discussions: 10% Case studies: 10% Distance learning or home work not included in the 325 hours. The course is held: 1 st year: at a single site (basic Module) 2 nd year: with rotation to several places in different countries Database Courses in PM Page 7 of 33

8 The programme covers all items mentioned in the Syllabus of the Faculty of Pharmaceutical Medicine. 6. Hours of teaching: Clinical Research: Regulatory Affairs: Pharmacovigilance: Statistics: Pharmaco-economics: An extended Module on business matters is being considered. 120 hours 90 hours 20 hours 20 hours 75 hours 7. Teachers: Total number of teachers participating in the programme: 65 Of whom: From Industry and CROs: 31 From academic institutions: 32 From Regulatory Authority: 2 8. Course material: The course material consists of paper documents as well of electronic media. The material is prepared by each teacher. 9. Students: Average number of students registering each year*: To the full course: 7 To individual Seminars: 14 To the examinations: 7 * The figures refer to 1999, the year of foundation of the Course. Requirements to register for the Course and the examinations: MDs and PhDs in biosciences (veterinary, pharmacists, biologists) Ratio physicians 70 non-physicians (year 1999) 50% / 50% 10. Examinations: 1 st year: at the end of each 3 weeks session 2 nd year: at the end of each specialized Module To obtain the Diploma: - submission of a Dissertation - final oral examination - at least 6 months training in a pharmaceutical company The examinations are both written and oral. The written examination includes: Multiple Choice Questions (MCQs): In the choices given there are several correct answers. 40 at each session A specific Committee prepares and updates the MCQs. Duration of the written examination: 3 hours Database Courses in PM Page 8 of 33

9 Duration of the oral examination: 1 hour per candidate Attendance to the courses is not compulsory for sitting the examination. Assessments are done also during the course. 11. Recognition: The Course has been recently recognised by the European Commission 12. Fees: Fee for the attendance to: The full Course: Single Module/Seminar: The examination: No fee is requested for awarding the diploma. 4,485 Euro for the two years 152 Euro/day none SUMMARY The postgraduate course in Lyon deviates in several respects from the classical course on Pharmaceutical Medicine. Firstly, it was successful in obtaining the sponsorship of the European Union (Socrates programme). Secondly, it involves the participation of 16 Universities in 11 countries of the European Union. Thirdly, the Faculty is quite international, involving many speakers from, besides France, the United Kingdom, Sweden, Germany, Italy and others. Fourth, the structure of the course is at variance in that it offers, in the second year, a series of options in which the candidate can choose for a subspecialty (drug development, regulatory affairs, post-marketing monitoring, promotional activities). During the first year, all students attend three residential Seminars of three weeks duration; this represents a basic Module composed of 18 sub-modules. In the second year, the students specialise in one of the options mentioned above and attend at least 4 Modules, each of 2 weeks duration. In the first year, all courses are taught at the University of Lyon, but in the second year, students are supposed to move around the various participating Universities. To obtain the diploma, the candidate has to sit written and oral examinations and submit a dissertation. Physicians, pharmacists, dentists, veterinaries and PhDs in Life Sciences are accepted. The total fee is 4485 Euro for the two years. Database Courses in PM Page 9 of 33

10 IRELAND 1. Title of the Course: Master of Science in Pharmaceutical Medicine 2. Main University organising the Course: Hibernia College 3. Address of Secretariat of the Course: 2, Clare Street Dublin 2 Ireland Telephone number: +353 (0) Fax number: +353 (0) address: ifapp@hiberniacollege.net Web site: 4. Year of Foundation of the Course: 2005 Language of the Course: English 5. Seminars/Modules: Number of Seminars/Modules: 10: Module 1 Module 2 Module 3 Module 4 Module 5 Module 6 Module 7 Module 8 Module 9 Module 10 Leadership & Authority Discovery of New Medicines Clinical Pharmacology and Drug Development Clinical Trials; Data Management and Statistics Safety and Risk Management Information Technology and e-medicine Business and Pharmaceutical Ethics Regulatory Affairs and Knowledge Management Health Economics, Business Administration & Medical Affairs Research Project Of these 10 modules 7 are taught on-line, 2 are taught on-site and 1 consists of working on a research project and the writing of a dissertation. Each of the 7 on-line modules is available for study on-line for 16 weeks. They are running 2 by 2 in parallel totalling 4 x 16 weeks distributed over 2 years. The 16 weeks of each on-line module are used as follows: - Week 1: Induction week - Weeks 2 13: Each week the students are expected to learn a lesson taking an average of 3 hours, to look at a live tutorial taking 1 hour and to spend 6 hours on private study. Thus the students spend 10 hours study time each week i.e. 120 hours over the 12 weeks. - Weeks14 and 15: are devoted to the reading of study material provided by Hibernia College which is taking an average of 10 hours per week i.e. a total of 20 hours for the two weeks. - Week 16 is spent on the assessment of the knowledge gained. Database Courses in PM Page 10 of 33

11 The on-site modules are: - Module 1: Leadership and Authority taught at the Kennedy School of Government at Harvard. - Module 7: Business and Pharmaceutical Ethics taught at the College of Surgeons in Dublin Each on-site module takes 36 hours teaching plus an assessment. The on-site modules are not compulsory. They can be learned on-line by those students who cannot attend the courses in Harvard and/or Dublin. Frequency of seminars/modules: 2 modules/semester The seminars/modules are spread over 2 years The full course contains 432 hours of teaching distributed as follows: Seminars (didactic lectures): 3 x 12 x 7 = 252 hrs Workshops: Leadership (36) + Ethics (36) = 72 hrs Group discussion: 1 x 12 x 9 = 108 hrs Private study: (6 x 12) + 20) x 9 = 828 hrs Thesis: 280 hrs (estimate) Distance learning or home work: yes The programme covers all items mentioned in the IFAPP Syllabus and the syllabus of the Faculty of Pharmaceutical Medicine in London. 6. Hours of teaching: Clinical Research: 88 hrs Regulatory Affairs: 24 " Pharmacovigilance: 48 " Statistics: 20 " Pharmaco-Economics: 28.." Marketing & Business matters: 71 " 7. Teachers: Total number of teachers participating in the programme: 46 Of whom: From Industry: 14 From CROs: 5 From academic institutions: 17 From Regulatory Authority: 0 From other organisations: 10* * Private pharmaceutical consultants or small consultancy companies. 8. Course material The course material consists of paper documents as well as of electronic media. The course material is prepared by each teacher. 9. Students Average number of students registering each year: To the full course: 40 To individual seminars:: N.A. Database Courses in PM Page 11 of 33

12 To the examinations: 40 Requirements to register for the course and the examinations MDs, Physicians and PHDs in biosciences (veterinary, pharmacy, biology). Participants must satisfy normal HETAC (Higher Education and Training Awards Council ( entry requirements, i.e.: Honours Bachelor degree in a science subject. Applicants should also be working in the pharmaceutical industry or a CRO. 10. Examinations Each module is assessed by a combination of continuous assessment (usually an essay or case study) and an examination at the end of the module. The marks awarded for continuous assessment and examination are usually in the ratio of 40:60. The final course award is based on the cumulative grades from all of the individual course modules. Students must pass each module. The examinations are only written. The written examination includes Multiple Choice Questions (MCQs). at each session. The number of questions varies since some module examinations consist of a number of assessment strategies of which MCQs represent only one tool. The number of correct chices varies according to the assessment strategy of the module. Short questions or short dissertations are also employed in the assessment. Each teacher individually, overseen by the Course Director and an External Examiner, prepares and updates the MCQs. The duration of the written examination is 3 hours. Attendance to the course is compulsory for sitting the examination. 11. Recognition The course is recognised by HETAC (see above) and it is planned to have it recognised by the National Health Authorities, the National Academy of Medicine, the Faculty of Pharmaceutical Medicine, the Regulatory Authorities and the Employers. also 12. Fees Fee for the attendance to: The full course: Single modules/seminars: The examination: No fee is requested for awarding the diploma. 20,000 Euro N.A. Included in the fee for attendance. Database Courses in PM Page 12 of 33

13 SUMMARY Hibernia College, in association with Pfizer Inc. has developed a new web-based masters program in Pharmaceutical Medicine. This is the only ONLINE Master s course in Pharmaceutical Medicine. The syllabus for this course incorporates all of the recommendations of the Council for Education in Pharmaceutical Medicine (CEPM) of the International Federation of Associations of Pharmaceutical Physicians (IFAPP). The syllabus also covers the content required by the Faculty of Pharmaceutical Medicine, Royal College of Physicians, UK. In addition to the core content required by these bodies, the Hibernia course offers education in a broader area of expertise, including leadership and negotiation, the fundamentals of IT and technological advances in the pharmaceutical industry, emedicine, business ethics, intellectual property protection regulations, health economics and finance. There is also a research project and dissertation aimed at answering mission critical issues within the students individual areas of employment. This research project provides students with an opportunity to synthesise the course as a whole in to a single piece of high quality research. The course is taught by academics from some of the world s leading Universities and from specialists from within the pharmaceutical industry from companies such as Pfizer, AstraZenaca and SmithKlineBeecham. The course is open to both physicians and non-medical specialists who are employed in the pharmaceutical industry in areas such as Pre-Clinical Pharmacology, Clinical Monitoring, Data Management, Drug Safety and Clinical Project Management. The course provides the opportunity for career advancement and cross-specialisation in the area of Clinical Development. Database Courses in PM Page 13 of 33

14 IRELAND 1. Title of the Course: Postgraduate Diploma / MSc in Pharmaceutical Medicine 2. Main University organising the Course: The University of Dublin, Trinity College 3. Address of Secretariat of Course: Centre for Advanced Clinical Therapeutics (CACT), St James s Hospital, Dublin 8 Ireland Telephone number: Fax number: address: cact@stjames.ie Web site: Course Director: Course Co-ordinator: Dr Mary Teeling Dr MaryJo MacAvin 4. Year of Foundation of the Course: 2004 Language of the Course: English 4. Seminars/Modules: Number of Seminars/Modules: Duration of each Seminar/Module: Frequency of the Seminars/Modules: Distribution of Seminars/Modules over time: 10 modules 8 of which are lecture based and 2 of which are distance learning days for taught lectures; 24 hours for each distance learning module. 2 each academic term (3 terms in year 1 and 2 terms in year 2) 18 months Hours of teaching of the full course contain: 220 hours Distribution: Seminars (didactic lectures): 75% Workshops: 10% Group discussions: 5% Other: Pre-reading 10% Distance learning or home work scheduled in the course: Yes 2 of the modules are distance learning. Prior to each module the students are provided with a reading list and they are also required to complete assignments following each module The course is taught: All in one place The programme of the Course covers all items mentioned in the Syllabus of The Faculty of Pharmaceutical Medicine (London). Database Courses in PM Page 14 of 33

15 6. Hours of teaching: Clinical Research: Regulatory Affairs: Pharmacovigilance: Statistics: Pharmaco-Economics: Marketing & Business matters: Principles of pharmacology and therapeutics Pre-clinical development 45 hours 30 hours 25 hours 25 hours 25 hours 20 hours 25 hours 25 hours 7. Teachers: Total number of teachers participating in the programme: Of whom: From Industry: 25% From CROs: 3% From Academia: 14% From Regulatory Authority: 10% From other organisations: 7% (Included are experts from the legal profession, the Department of Health, National Centre for Pharmacoeconomics and National Medicines Information Centre) 8. Course material: The course material consists of paper documents as well as of electronic media. The course material is prepared by teachers individually 9. Students: Average number of students registering each year: To the full course: Maximum of 12 students To individual seminars: Not applicable To the examinations: All registered students are required to take examinations. Requirements to register for the course and the examinations: for the postgraduate diploma: Physicians only for the MSc course: Physicians and graduates in biosciences (e.g. pharmacists, pharmacologists, biologists etc) Usual ratio physicians versus non-physicians: 50% 50% 10. Examinations: Examinations are conducted at the end of the course. The examinations are both written and oral. The written examination includes: Multiple Choice Questions (MCQs): for postgraduate diploma only. Number of MCQs asked at each session: 50 questions In the choices given there is only one correct answer. Short questions: yes, for all students Short dissertations: yes, for MSc only Database Courses in PM Page 15 of 33

16 The course Management Committee writes and updates the MCQs. Duration of the written examination: 3 hours (+ 3 hour for MCQ examination) Duration of the oral examination: minutes Attendance to the courses is compulsory for sitting the examination: Students must complete all 10 modules. They must attend 6 of the 8 lecture based modules in addition to participating in the distance learning modules. Assessments during the course: Students must complete assignments for each module. 11. Recognition: We do intend to have our course recognised by our National Academy of Medicine* and the Faculty of Pharmaceutical Medicine**. * this is an accredited course approved by the University of Dublin, Trinity College. ** the Faculty of Pharmaceutical Medicine is being established in Ireland at present. 12. Fees: Fee for the attendance to: The full course: This is a university accredited postgraduate course. University fees for Year was 4,512 (EU students) and 12,306 (non-eu) Single Module/Seminar: Not applicable The examination: Included in the course fees. There is no fee requested when awarding the diploma. SUMMARY These postgraduate diploma/msc courses in pharmaceutical medicine were set up in Ireland to provide suitably qualified healthcare professionals with specialist knowledge and skills in pharmaceutical medicine to enable them extend their professional role within the pharmaceutical industry and healthcare system. The courses are organised by the Centre for Advanced Clinical Therapeutics (CACT), St James s Hospital, Dublin in association with The University of Dublin, Trinity College. Prospective students for the postgraduate diploma must hold a primary degree in medicine and should have a minimum of 2 years'genral medicine experience post-registration. Prospective student for the MSc course must hold a primary degree in either medicine or another relevant health or science subject and should have a minimum of 2 years' practical experience in their area of qualification/pharmaceutical industry. The courses which are part-time, are run over 18 months to 2 years and consist of 10 modules, of which 8 are taught on site and 2 are distance learning. in addition to written and oral examinations at the end of the course, student are continuously assessed by way of written assignments that must be completed following the end of each module. Students must attend at least 6 of the 8 lecture based modules in addition to completing the distance learning modules. Throughout the course, student are ab;e to keep in contact with each other and with course organisers by way of an interactive electronic learning system WebCT. At the end of the course, postgraduate diploma students are required to undertake a multiple choice paper (based on pharmacotherapy) and written and an oral examination at the end of the Database Courses in PM Page 16 of 33

17 taught course. In addition they are also required to undertake a research project and submit a dissertation within a designated time-frame. The lecturers and module leaders for the course come from the pharmaceutical industry, the regulatory authority, academia and the healthcare sector. The course receives ongoing support from all these areas. Each taught module contains a keynote lecture from an internationally known expert in the field. The course is overseen by a management committee which consists of nine members, representing the University of Dublin, Trinity College, CACT, as well as representatives from the regulatory authority and the pharmaceutical Industry. The students are also represented on the management committee. Database Courses in PM Page 17 of 33

18 SERBIA 1. Title of the Course: Postgraduate Diploma in Pharmaceutical Medicine (Universitu Specialist in Pharmaceutical Medicine) 2. Main University organising the Course: School of Medicine, University of Belgrade 3. Address of Secretariat of Course: Dept. of Pharmacology, Clinical Pharmacology and Toxicology Telephone number: Fax number: address: Web site: Course Director: Course Administrator: address: Prof. Dr Milica Prostran, MD,PhD Dr Radan Stojanovic, MD, MSc; 4. Year of Foundation of the Course: 2004 Languages of the Course: Serbian/English 5. Seminars/Modules: Number of Seminars/Modules: Duration of each Seminar/Module: Frequency of Seminars/Modules: Distribution of Seminars/Modules over time: 12 modules 1-2 days weekly 1 year Hours of teaching of the full course: 359 Distribution: Lectures 208 hrs Seminars 93 hrs Workshops: 58 hrs Seminars and Workshops include Group Discussions and Paper Essays. Home work is also part of the course. The course is taught at several places in Belgrade. The programme of the Course covers all items mentioned in the Syllabus of the Faculty of Pharmaceutical Medicine. 6. Hours of teaching: Clinical Research: Regulatory Affairs: Pharmacovigilance: Statistics: 100 hrs 24 hrs 40 hrs 16 hrs Database Courses in PM Page 18 of 33

19 Pharmaco-economics: Marketing & Business matters: 32 hrs 40 hrs 7. Teachers: Total number of teachers participating in the programme: 55 Of whom: From Industry: 9 From CROs: 6 From Academia: 13 From Regulatory Authority: 6 From other organisations: University Hospitals: 11 Ethics Committees: 1 Multimedia: 1 Legal affairs: 2 School of Economics: 1 School of Pharmacy: 4 School of chemistry: 1 8. Course material: The course material consists of paper documents as well as of electronic media. The material is prepared by each teacher. 9. Students: Average number of students registering: To the full course: 15-20/year Requirements to register for the course and the examinations: Degree in Medicine only 10. Examinations: Examinations are held twice a year and are both written and oral The written examination is based on 60 Multiple Choice Questions (5 questions x 12 modules) with several correct answers and on a series of short questions. In the examination a short dissertation is also included. The Director of the Course writes and updates the MCQs Duration of the written examination: Duration of the oral examination: 2 hrs 1 hr Attendance to 85% of the course is compulsory for sitting the examination. Assessments are performed also during the course. Database Courses in PM Page 19 of 33

20 11. Recognition: The Course has presently the recognition of the National Association of Employers, of the NHA, of the National Academy of Medicine, of the Regulatory Authorities and of the Serbian Association of Pharmaceutical Physicians. It is the intention of the Course organisers to have also the recognition of the Faculty of Pharmaceutical Medicine. 12. Fees: Fees for attendance to: The full course: Single modules/seminars: The examination: 1200 Euro NA 400 Euro A fee is requested when awarding the diploma. SUMMARY This is a 1-year non-residential course consisting of 12 Modules of various duration (between 10 and 100 hours) depending on the subject; the total number of teaching hours is 359 (208 hours of training programme lectures, 93 hours of training programme seminars, 59 hours of training programme workshops). Courses will be taught at the Dept. of Pharmacology, Clinical Pharmacology and Toxicology, School of Medicine, University of Belgrade. The programme covers all items mentioned in the Syllabus of the Faculty of Pharmaceutical Medicine. The course is open only to registered physicians who have recently joined the pharmaceutical industry, a contract research organisation (CRO) or working for a drug regulatory agency. The expected number of attendants is up to 20 per year. The course is officially recognised by the School of Medicine, University of Belgrade, the National Education Authority and the Serbian Association of Pharmaceutical Physicians. The examinations are both written and oral and they are conducted twice a year. The fee for the full course and the examination is around 1600 Euro. Database Courses in PM Page 20 of 33

21 SPAIN (Barcelona) 1. Title of the Course: Postgraduate Diploma in Pharmaceutical Medicine (Diploma de Postgrado»Medicina de la Industria Farmacéutica«) 2. Main University organising the Course: Autonomous University of Barcelona (Universitat Autonoma de Barcelona) 3. Address of Secretariat of Course: Department of Clinical Pharmacology Hospital de la Sta. Creu i St. Pau Avda St Antoni Ma. Claret, 167 E Barcelona Spain Telephone number: Fax number: address: fjane@hsp.santpau.es Course Director: Prof. Francesc Jané 4. Year of Foundation of the Course: 1986 Language of the Course: Spanish 5. Seminars/Modules: Number of Seminars/Modules: 14 Duration of each Seminar/Module: 4 to 24 hours Frequency of Seminars/Modules: 1 day/week from January to June Distribution of Seminars/Modules over time: 2 years (compulsory) Hours of teaching of the full course: 210 Distribution: Seminars (didactic lectures): 70% Workshops: 20% Group discussions: 10% Distance learning or home work: no The course is taught: At a single site The programme of the Course covers all items mentioned in the Syllabus of the Faculty of Pharmaceutical Medicine. 6. Hours of teaching: Clinical Research: Regulatory Affairs: Pharmacovigilance: Statistics: Pharmaco-economics: Marketing & Business matters: 60 hours 10 hours 10 hours 14 hours 8 hours 16 hours Database Courses in PM Page 21 of 33

22 7. Teachers: Total number of teachers participating in the programme: 46 Of whom: From Industry: 16 From CROs: 3 From academic institutions: 12 From Regulatory Authority: 5 From other organisations: University Hospitals (mostly Clinical Pharmacologists) 7 Toxicologists 3 8. Course material: The course material consists of paper documents as well as of electronic media. The course material is prepared by each teacher. 9. Students: Average number of students registering: To the full course: 25 every two years To individual Seminars: not applicable To the examinations: 30 Requirements to register for the course and the examinations: Degree of Medicine, Veterinary, Pharmacy, Biology Physicians and PhDs in biosciences (veterinary, pharmacists, from 1996 biologists): Usual ratio physicians to non-physicians: 100% physicians from 1986 to % to 45% from 1996 to 2000 (last 2 diplomas) 10. Examinations: Examinations are held every two years and are only written. The written examination includes: Multiple Choice Questions (MCQs): 80 at the end of the 1 st year In the choices given there is only one correct answer Short questions Who writes and updates the MCQs? (please circle right answer) Each teacher individually with supervision by a specific committee Duration of the written examination: 1.30 to 2.00 hours Attendance to 80% of the Course is compulsory for sitting the examination. Assessments are made also during the course. Database Courses in PM Page 22 of 33

23 11. Recognition: Although not officially, the Diploma is recognized both by the employers of the pharmaceutical industry and the Regulatory Authorities 12. Fees: Fee for the attendance to: The full course: Single Module/Seminar: The examination: A fee is requested for awarding the diploma. +/- 3,000 Euro not applicable none SUMMARY This is a 2-year non-residential course consisting of 14 Modules of various duration (between 4 and 30 hours) depending on the subject. Courses are all taught at the University, 1 day per week from January to June of each year representing a total of 220 hours of teaching by 46 teachers of which 16 are from Industry. The average number of students registering every two years is 30. Up to 1996, only physicians were eligible for attending the course; since 1996, PhDs in Life Sciences are also accepted. The present ratio of physicians to non-physicians is 55% to 45%. Examinations are written only. To register for the examination, candidates need to have attended at least 80% of the course. The fee for the full course is around 3000 Euro. Database Courses in PM Page 23 of 33

24 SPAIN (Madrid) 1. Title of the Course: Especialista Universitario en Medicina Farmacéutica (University Specialist in Pharmaceutical Medicine) 2. Main University organising the Course: Universidad Complutense de Madrid 3. Address of Secretariat of Course: Departamento de Farmacologia Facultat de Medicina Universidad Complutense E Madrid Spain Telephone number: Fax number: address: Course Director: Prof. Pedro Lorenzo 4. Year of Foundation of the Course: 1986 Language of the Course: Spanish 5. Seminars/Modules: Number of Seminars/Modules: 14 Duration of each Seminar/Module: 6 days Frequency of Seminars/Modules: 2 per month (from October to June) Distribution of Seminars/Modules over time: 2 years Hours of teaching of the full course: 300 hours Distribution: Seminars (didactic lectures): 73% Workshops: 13% Group discussions: 8% Other: 6% Distance learning or home work: no The course is taught: at a single site The programme of the Course covers all items mentioned in the Syllabus of the Faculty of Pharmaceutical Medicine. 6. Hours of teaching: Clinical Research: Regulatory Affairs: Pharmacovigilance: Statistics: Pharmaco-economics: Marketing & Business matters: 60 hours 6 hours 9 hours 12 hours 3 hours 24 hours Database Courses in PM Page 24 of 33

25 7. Teachers: Total number of teachers participating in the programme: 88 Of whom: From Industry: 47 From CROs: 6 From academic institutions: 25 From Regulatory Authority: 6 From other organisations: 4 (from Ethics Committees) 8. Course material: The course material consists of paper documents as well as of electronic media. The course material is prepared by each teacher. 9. Students: Average number of students registering: To the full course: 30 every two years To individual Seminars: not applicable To the examinations: 30 Requirements to register for the course and the examinations: Physicians only: from 1986 to 1996 (First 5 diplomas) Physicians and PhDs in biosciences (veterinary, pharmacists, biologists): from 1996 Usual ratio physicians to non-physicians: 60% to 40% 10. Examinations: Examinations are held once a year and are both written and oral. The written examination includes: Multiple Choice Questions (MCQs): In the choices given there is only one correct answer Short questions. 60 at each session Each teacher individually prepares and updates the MCQs. Duration of the written examination: Duration of the oral examination: 2 hours 20 minutes per group Attendance to 75% of the course is mandatory for sitting the examination. Assessments are made also during the course. 11. Recognition: The Course is already recognised by AMIFE (Medical Association of Physicians working in the Pharmaceutical Industry), by employers of the Pharmaceutical Industry, the University, CROs and the Health Ministry. Database Courses in PM Page 25 of 33

26 12. Fees: Fee for the attendance to: The full course: Single Module/Seminar: The examination: A fee is requested for awarding the diploma. 2,105 Euro not applicable none SUMMARY This 2-year non-residential course consists of 14 Modules distributed over the months of October to June each year and totalling 300 hours of teaching at the University by 88 teachers of which 47 belong to Industry. Around 30 students are registering every two years. Up to 1996 they had to be physicians, but since then PhDs in Life Sciences are also accepted. The present ratio of physicians to non-physicians is 60% to 40%. Examinations are conducted once a year and are both written and oral. To register for the examinations, students must have attended at least 75% of the course. The fee for the full course is 2,105 Euro. Database Courses in PM Page 26 of 33

27 SWEDEN 1. Title of the Course: Course in Pharmaceutical Medicine 2. Main University organising the Course: Karolinska Institutet 3. Address of Secretariat of Course: Pharmaceutical Medicine Course Secretariat Department of Medicine Division of Clinical Pharmacology L7:05 Karolinska Hospital S Stockholm Sweden Telephone number: Fax number: address: Web site (if available): htttp:// Course Administrators: Prof. Pierre Lafolie (Karolinska) Prof. Bjorn Beermann (MPA) 4. Year of Foundation of the Course: 2001 Language of the Course: English 5. Seminars/Modules: Number of Seminars/Modules: Duration of each Seminar/Module: Frequency of Seminars/Modules: Distribution of Seminars/Modules over time: Hours of teaching of the full course: How is this distributed over : Seminars (didactic lectures): 60% Workshops: 20% Group discussions: 20% Other: Distance learning or home work: The course is taught in the same country, but rotating to several places days 1 per month 2 years 350 hours home work, group sessions between Modules The programme of the Course covers all items mentioned in the Syllabus of the Faculty of Pharmaceutical Medicine. yes Database Courses in PM Page 27 of 33

28 6. Hours of teaching: Clinical Research: 150 Regulatory Affairs: 50 Pharmacovigilance: 35 Statistics: 50 Pharmaco-economics: 35 Marketing & Business matters: Teachers: Total number of teachers participating in the programme: Approx. 35 Of whom: From Industry: 10 From CROs: 1 From academic institutions: 10 From Regulatory Authority: 10 From other organisations: 4 (Stockholm School of Economics) 8. Course material The course material consists of paper documents as well as of electronic support. The course material is prepared by each teacher in collaboration with the Master of Session. 9. Students: Average number of students registering each year: To the full course: 15 To individual Seminars: 15 To the examinations: 15 Requirements to register for the course and the examinations: Degree in Medicine 10. Examinations: Assessments are performed at the end of each Module The examinations are both written and oral The written examination includes: Short questions Short dissertations It does not include Multiple Choice Questions (MCQs). Duration of the written examination: Duration of the oral examination?: 2 hours 2 hours The attendance to the courses is not compulsory for sitting the examination. The attendance to group work is mandatory Assessments are also made during the course. Database Courses in PM Page 28 of 33

29 11. Recognition: The course is organized in collaboration with MPA (The Swedish Medical Agency, cf.mca) The course is organized, approved and recognized by Karolinska Institutet Only employers can contract staff for participation. 12. Fees: Fee for attendance to: The full course: Single Module/Seminar: To the examination: No fee is requested for awarding the diploma. 20,000 Euro not applicable none SUMMARY The postgraduate course at Karolinska Institutet is remarkable from several points of view. First, it results from a collaboration between the University of Stockholm and the national Regulatory Authorities (MPA: Medical Products Agency) instead of the University and the national Association of Pharmaceutical Physicians. Second, only physicians are accepted on the course. Third, only employers can contract staff for participation. Fourth, it is by far the most expensive postgraduate course in Pharmaceutical Medicine The course has 14 Modules of 3 days each held at regular intervals over 2 years (350 hours). Courses are given at various conference hotels. Full accommodation including meals is around 300 Euro per Module. The fee for the full course is 20,000 Euro and comes in addition to the accommodation costs. Written and oral assessments are performed at the end of each Module; a diploma is awarded to those who pass the 11 assessments. Database Courses in PM Page 29 of 33

30 SWITZERLAND 1. Title of the Course: European Course in Pharmaceutical Medicine 2. Main University organising the Course: University of Basle, under the auspices of EUCOR (European Confederation of the Upper Rhine Universities: Basle (Switzerland), Freiburg i.br. (Germany), Strasbourg (France) 3. Address of Secretariat of Course: European Center of Pharmaceutical Medicine (ECPM) Executive Office University Hospital CH-4031 Basel, Switzerland Telephone number: Fax number: address: ecpm@unibas.ch Web site: Course Director: Course Manager: Course Administrator: Prof. Fritz R. Bühler, Prof. Thomas Szucs Dr. Annette Mollet Mrs Isabelle Steiger 4. Year of Foundation of the Course: 1991 Language of the Course: English 5. Seminars/Modules: Number of Seminars/Modules: 6 Duration of each Seminar/Module: 4 days Frequency of Seminars/Modules: 3 per year Distribution of Seminars/Modules over time: 6 over 2 years Hours of teaching of the full course:?: 264 hours (300 hours when including distance learning and preparation) Distribution: Seminars (didactic lectures): 66% Workshops: 17% Group discussions: 17% Distance learning or home work: The course is taught: yes At a single site; in two ocations The programme of the Course covers all items mentioned in the Syllabus of the Faculty of Pharmaceutical Medicine. Database Courses in PM Page 30 of 33

31 6. Hours of teaching (distance learning included): Clinical Research: Regulatory Affairs: Pharmacovigilance: Statistics: Pharmaco-economics: Marketing & Business matters: 150 hours 45 hours 16 hours 48 hours 12 hours 19 hours 7. Teachers: Total number of teachers participating in the programme: 131 Of whom: From Industry: 57 From CROs: 13 From academic institutions: 32 From Regulatory Authority: 12 From other organisations: 14 WHO 31 Legal affairs 3 Health insurance 2 Multimedia 3 Biotech 6 8. Course material: The course material consists of paper documents as well as of electronic media. The specified course material is prepared by each teacher, thereafter it is assembled and formatted by the ECPM Executive Office. 9. Students: Average number of students registering: To the full course: 140 every two years To individual Seminars: 40 To the examinations: 100 Requirements to register for the course and the examinations Physicians, PhDs and Master in Life Sciences (veterinary, pharmacists, biologists, chemists etc.) Usual ratio physicians to non-physicians: 35% to 65% 10. Examinations: The Examination will qualify as a Bachelor of Advanced Studies in Pharmaceutical Medicine starting in July Examinations are held in collaboration with the Swiss Association of Pharmaceutical Professionals (SwAPP) and Physicians (SGPM) Examinations are held once every two years and are both written (multiple choice, essay) and oral The written examination includes: Multiple Choice Questions (MCQs): 120 (20 per Module) In the choices given there is only one correct answer in 80% of Questions and several correct ones in 20% of Questions Short questions: 3 essays topics to choose out of a list of 17 items Database Courses in PM Page 31 of 33

32 Each teacher individually writes the MCQs which are then validated and updated by a specific committee. Duration of the written examination: Duration of the essays/short questions (written dissertation on 3 cases): Duration of the oral examination?: Preparation of peer reviewed paper for oral exam: Attendance to the Course is compulsory for sitting the examination. Assessments are also made during the course? 4 hours 2 hours 30 minutes 30 minutes No but advised Yes, self assessments 11. Recognition: The Course is recognised by the Swiss Academy of Medicine (FMH, Federatio Medicorum Helveticorum), EUCOR Universities, the Swiss Association of Pharmaceutical Professionals (SwAPP) and Physicians (SGPM), the Pharmaceutical Industry and Regulatory Authorities (e.g. Swissmedic). 12. Fees: Fee for the attendance to: The full course: 2,333 Euro for University members Single Module/Seminar: The examination: No fee is requested for awarding the diploma. 6,833 Euro (including course material examination, lunches and diploma) not applicable none (in the future for the Bachelor there will be a fee which is not defined yet) SUMMARY Although the University of Basle plays a predominant role in its organisation and management, this 2-year residential course is a collaborative effort of EUCOR, the European Confederation of the Upper Rhine Universities (Basle, Freiburg i.br. and Strasbourg). It counts six Modules; each Module takes 4 consecutive days of intense teaching; three Modules are taught per year. All together, course sessions add up to 264 hours of teaching. When distance learning is included one reaches 300 lessons of accredited instruction which equals 30 ECTS (European Credit Transfer System) points. All Modules are taught at the European Centre of Pharmaceutical Medicine in Basle by 131 teachers of which 57 are from Industry. Around 140 students are registering to the course every 2 years. Both physicians, PhDs and Master in Life Sciences are accepted on the course. The physicians to non-physicians ratio is 35% to 65%. Oral and written (MCQ and essay) examinations are organised every 2 years. Starting in July 2005 this examination will qualify as a Bachelor of Advanced Studies in Pharmaceutical Medicine which is accredited Europe wide via the Bologna System. Physicians who pass the examination at the ECPM or at another postgraduate course following the IFAPP core syllabus may apply together with the proof of their practical experience with the Swiss Medical Association (FMH) for the official title of FMH-Specialist in Pharmaceutical Medicine. Non- MD s can apply for a Master of Advanced Studies in Pharmaceutical Medicine by providing the proof of practical experience and by writing a diploma thesis. Database Courses in PM Page 32 of 33

33 UNITED KINGDOM (Cardiff University, Wales) 1. Title of the Course: Postgraduate Course in Pharmaceutical Medicine 2. Main University organising the Course: Cardiff University, Wales 3. Address of Secretariat of Course: Welsh School of Pharmacy Cardiff University Redwood Building King Edward VII Avenue Cardiff CF10 3XF United Kingdom Telephone number: Fax number: address: Course Director: Course Administrator: Prof. Sam Salek Ms Helen Harron 4. Year of Foundation of the Course: 1976 Language of the Course: English 5. Seminars/Modules: Number of Seminars/Modules: 10 Duration of each Seminar/Module: 3 days Frequency of Seminars/Modules: one approx every 8 weeks, from September to June Distribution of Seminars/Modules over time: 2 years Hours of teaching of the full course: 200 hours Distribution: Seminars (didactic lectures): 100 hours Workshops: 50 hours Group discussions: 25 hours Other: Small group exercise: 25 hours Distance learning or home work: no Is the course taught: in the same country, but rotating to several places The programme of the Course covers all items mentioned in the Syllabus of the Faculty of Pharmaceutical Medicine. Database Courses in PM Page 33 of 33

34 6. Hours of teaching: Clinical Research: Regulatory Affairs: Pharmacovigilance: Statistics: Pharmaco-economics: Marketing & Business matters: 5 hours 5 hours 5 hours 20 hours 15 hours 30 hours 7. Teachers: Total number of teachers participating in the programme: 77 Of whom: From Industry: 37 From CROs: 10 From academic institutions: 10 From Regulatory Authority: 5 From other organisations: 10 independent Pharmaceutical Medicine Consultants; 5 clinicians. 8. Course material: The course material consists of paper documents and is prepared by each teacher, sometimes in collaboration with the organisers of the Course. 9. Students: Average number of students registering: To the full course: To individual Seminars: To the examinations: 140 every two years not applicable 48 (on completing the 2 nd yr of the course) Requirements to register for the course and the examinations: Degree in medicine 10. Examinations: The Course participants sit the Faculty of Pharmaceutical Medicine examination at the end of the two years Course. The information below is relating to the latter examination. Examinations are held once a year and are both written and oral. The written examination includes: Multiple Choice Questions (MCQs): In the choices given there is only one correct answer. Short questions. Essay questions. 50 at each session A specific Committee (Board of Examiners, Faculty of Pharmaceutical Medicine) writes and updates the MCQs. Duration of the written examination: Duration of the oral examination: 5 hours 45 minutes Attendance to the course is not compulsory for sitting the examination. MCQ assessment at the end of each module. Database Courses in PM Page 34 of 33