- MPharm., Specialist in Pharmacy (Cyprus), QP Specialist & QC Specialist (Serbia) Dragana Boberity Borojevity
- PHMC (Cyprus) Ltd , Director
As former Head of Registrations Committee at the Institute of Pharmacy & Head of National Control Laboratory Department - Instrumental Laboratory (at the present days - Agency for Medicines and Medical Devices of the Republic of Serbia) she gained a tremendous experience in QC lab operations including various techniques of the instrumental analysis (MS, HPLC, GC, AAS, etc.) as well as in evaluation of the Quality part of registration dossiers for all kinds of medicines, MDs and supplements. She participated in regulation development, harmonization and implementation of EU legislation and ICH guidelines. She participated in GMP audits of the manufacturing sites. As former Assistant Minister of Health of the Republic of Montenegro, Head of Pharmaceutical Sector she had established Pharmaceutical Sector for the first time in Montenegro (at the present days - Agency for Medicines and Medical Devices of the Republic of Montenegro) and participated in development and implementation of the legislation regulating manufacture, registration and marketing of pharmaceuticals. She participated in GMP audits of the manufacturing sites, formal inspections of wholesale distributors and pharmacies, as well as in issuing of licenses for work. She has published 2 monographs and over 30 scientific articles.
As shareholder, Business Development Director, Head Project Manager, Lead GMP Auditor at Pharmillennium Consulting d.o.o. she managed and participated in development, contracting and realization of the projects of various scopes (clinical studies, BE studies, RA and PV services, Dossier evaluations, QOS writing, Dossier development, HR, PM, acquisitions of manufacturing sites and laboratories, know-how & technology transfers, analytical method transfers, GMP and QP audits of final products and API manufacturers, development and implementation of Pharmaceutical Quality Systems (PQS), GMP certifications, turn-key projects in designing, construction, equipping and start-up of pharmaceutical and MD manufacturing sites and QC laboratories, VMPs, qualifications and validations, etc. She’s organized and provided lectures for over 40 seminars, workshops, courses and trainings in the scopes of GMP, PQS, CTD and eCTD, RA, PV, EU legislation & ICH guidelines, MDs, human and veterinary medicines, QC, validations and qualifications, IT systems, etc. She is reputable pharmaceutical expert in the scope of the EU GMP, Pharmaceutical Quality Systems, QC, RA, Quality Expert, and certified QP/QC in Serbia