The specialty "Clinical Trial Management" of the OCS "master" offers training after completed master's degree in different specialties – medicine, dentistry, pharmacy, biology, economics, law and other professional fields.
Training is in absentee form, with duration 3 semesters.
Students are provided an opportunity to acquire general and specialized training in clinical trial management, design and development of a complete clinical trial protocol from formulation of research questions to analysis of results, application of epidemiologic principles, understanding of the concept of quantitative data synthesis, and for a preliminary form of meta-analysis of trial data using appropriate software, application of biostatistics and analytical modeling, business communication and patient communications, legal regulations and bioethics in clinical trials, monitoring and auditing of clinical trials, marketing of clinical trials and medicinal products, etc.
Graduates can perform organizational-management, economic, coordination-communicative, control and research functions.
COMPETITIVE EXAMINATION, FINAL SCORING AND CLASSIFICATION
Candidate students take an oral exam before a committee of three qualified teachers.
The oral exam is conducted as an interview on the topic: "Problems and prospects for conducting clinical trials in Bulgaria".
The oral exam will be held on 07/09/2020 from 9:00 a.m.
The competitive score is formed as the sum of the grade from the oral exam and the average grade from the diploma for a completed previous degree of higher education, not lower than "good". Ranking is done in descending order of competition ball. Maximum score 12.
LITERATURE FOR PREPARATION:
https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf
https://ec.europa.eu/health/human-use/clinical-trials/regulation_bg