WORKING MEETING ON ISSUES OF REGULATORY LEGAL ACCOMPANIMENT FOR CLINICAL TESTS OF MEDICAL DRUGS
07.11.2014
The working meeting, headed by pro-rector on scientific pedagogical activity, corresponding member in NAMS of Ukraine, professor Chaykovskyy Yu.B. on issues of regulatory legal accompaniment for clinical tests of medical drugs was held on 7, November, at Bogomolets NMU.
The heads of structural subdivisions of university, heads of clinical departments, at which the clinical researches of medical drugs are held, representatives from European Business Association took part in the meeting.
HEARD: Head of scientific research sector, professor Khaytovych M.V. reported about the main regulatory legal documents from clinical tests, emphasized the problematic issues: procedure and rules to form the contractual price; preservation of materials from clinical research during 15 years – who provides with?; procedure for administrative accompaniment of clinical researches; suggested to develop the Provisions about performance of clinical researches of medical drugs at university; to introduce the changes into rating assessment of work of departments at university in order to encourage them for clinical researches of medical drugs.
SPEAKERS:
– Head at department of Phthisiology and pulmonology, professor Petrenko V.I. emphasized the significance of purposeful use of funds and their correct distribution.
– Head at department of internal medicine No 3, professor Svintsytskyy A.S. about distribution of Contractual obligations.
– Head at department of neurology, professor Sokoklova L.I. mentioned the reasons for decrease in a number of researches; emphasized that the distribution of funds for performance of researches with correlation 50%:50% between medical preventive establishments and NMU is not reasonable, and further gave the reasoned offer to revise this distribution, mentioned about importance of the issue about periods of reporting and confident information about clinical researches.
– Lawyer of European Business Association Igor Svitlyk, representative of Subcommission on clinical tests Dmytro Semeniuta, lawyer Kateryna Shapran, coordinator of Subcommission on clinical tests Antonina Smolina gave the legal assessment for confidentiality of information, mentioned the procedure and correctness for actions by performers of clinical researches while appealing to the law enforcement controlling authorities.
THE FOLLOWING PERSONS ALSO TOOK PART IN DISCUSSION:
Professor Chaykovskyy Yu.B., Bodnar P.M., Kramaryov S.O., Muzychenko P.F., Borzenko I.O., Sokolova L.I., Dementyeva T.A.
RESOLVED: for scientific research part:
– Together with the planning financial and legal department of NMU until 1, December, 2014 to develop the Provisions about procedure for performance of clinical researches of medical drugs at university.
– Together with European Business Association until 15, November to develop the recommendations about procedure for actions in case of appeal with request to the competent authorities on issues of organization of clinical researches of clinical medical drugs.
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