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-28040 Madrid
Spain

Telephone number: +34-91-3941464
Fax number: +34-91-3941463
E-mail address: mevicent@eucmax.sim.ucm.es

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: 60 hours
Regulatory Affairs: 6 hours
Pharmacovigilance: 9 hours
Statistics: 12 hours
Pharmaco-economics: 3 hours
Marketing & Business matters: 24 hours

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): 60 at each session
In the choices given there is only one correct answer
Short questions.

Each teacher individually prepares and updates the MCQs.

Duration of the written examination: 2 hours
Duration of the oral examination: 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.

12. Fees:
Fee for the attendance to:
The full course: 2,105 Euro
Single Module/Seminar: not applicable
The examination: none
A fee is requested for awarding the diploma.

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.