International pharmaceutical regulatory seminar – ALMBiH

“Variations (changes) of marketing authorization for a medicinal product – European approach, evolution, principles and design, the new classification, harmonization”


The seminar is intended for employees of the competent authorities, industry and external associates in the field of regulation.


Work on variations for the marketing authorization of the drug are responsibilities of the marketing authorization holder and the competent authorities. This is regulatory and professional time demanding job which includes nearly two-thirds of regulatory activity on both sides.


Seminar was held in Sarajevo on 16th October 2015.


Clinres attended this conference.