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:  +381 11 684 363
Fax number:   +381 11 686 025
E-mail address:   prostranmv@med.bg.ac.yu
Web site:    www.med.bg.ac.yu

Course Director: Prof. Dr Milica Prostran, MD,PhD
Course Administrator: Dr Radan Stojanovic, MD, MSc;
e-mail address: radan@doctor.com

4. Year of Foundation of the Course: 2004
Languages of the Course:Serbian/English

5. Seminars/Modules:
Number of Seminars/Modules:12 modules
Duration of each Seminar/Module: 1 - 2 days
Frequency of Seminars/Modules:weekly
Distribution of Seminars/Modules over time: 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:      100 hrs
Regulatory Affairs:       24 hrs
Pharmacovigilance:       40 hrs
Statistics:        16 hrs
Pharmaco-economics:       32 hrs
Marketing & Business matters: 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: 2 hrs
Duration of the oral examination: 1 hr

Attendance to 85% of the course is compulsory for sitting the examination.

Assessments are performed also during the course.

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: 1200 Euro
Single modules/seminars: NA
The examination: 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.