- B.Sc.Pharm. Specialist Industrial Pharmacy, Specialist Batch certification and release to market (QP) Miloš Stajković
- Pharma Concept d.o.o., Deputy Director
- Pharmillennium Consulting d.o.o., MA Department Head
As former Senior Expert Associate – registration department at Esensa d.o.o. Belgrade, manufacturer of medical devices, food supplements and cosmetics, was responsible for - Registration/renewal/changes of medical devices, preparation of documentation for classification/categorization and registration of medical devices, preparation of documentation for medical devices and supplements manufacturing license, categorization of food supplements and registration including development of documentation for registration, qualifications, validations, Project management in development, construction and equipping of the new manufacturing facility, participation in implementation of ISO 13485, production planning, production documentation development and managing, new equipment procurement, technology transfers and scale up, training of employees.
As former Expert Associate – QP at Hemofarm AD, Vršac, manufacturer of medicines, medical devices, food supplements, cosmetics, was responsible for - Batch Certification and release to market (oral forms – tablets/capsules, syrups, parenteral forms – injections, infusions) for markets: Serbia, BH, MNE, MAK, markets of STADA group, Russia, contract manufacturing products release, review of batch documentation (manufacturing, packaging), samples review, batch certification, participation in deviation investigation, nonconformities, complaints, supervision of samples and documentation delivery to contract manufacturing clients, review of CoAs, participation in audits of suppliers (raw material, packaging material, bulk products), decision making about withdrawn products, damaged products, coordination of recall process, decision making about next production phase, product status determination, participation in team work (change control, deviation/nonconformity investigation), SOPs and working instructions writing, continuous monitoring of legislation.
At his present position within the Pharmillennium Consulting and Pharma Concept, he is managing and coordinating regional projects covering RA and PV services, MAH services, dossier review services, submissions management, negotiation and contracting, invoicing, etc. He is responsible for – contracting, coordination and management of RA, PV & MAH activities for medicines, medical devices, food supplements, cosmetic products in West Balkan Countries (WBC), Documentation evaluation (GAP analysis), preparation and submissions for marketing authorization/renewal/variation/transfer applications, compilation of CTD, Nees format, according to WBC and EU regulation, provision of full expert support in registration applications for medicines/medical devices, in answering Clock Stop/formal evaluation deficiencies, in pharmacovigilance/vigilance of medical devices, post-market surveillance, complaints, recalls, continuous monitoring of legislation, comparative reviews preparation, according to client request, providing expert consulting and advices to clients, development (SOP writing), implementation and maintenance of the QA system within the PHMC company’s network, as well as participation in realization of the services contracted by Pharmillennium Consulting and/or PHMC (Cyprus).
Pharma Concept d.o.o.
Company Register: 20839775
PIB 107627008
Registered Address:
Gandijeva 122a, lokal 4
11070 Novi Beograd
Serbia
Post Address:
Cara Uroša 12, ground floor
11000 Belgrade
Serbia
Office Belgrade Address:
Cara Uroša 12, ground floor
11000 Belgrade
Serbia
Email: office@pharmaconcept.rs
Phone: +381 11 408 69 05
+381 11 408 68 79
Mobile: +381 64 132 00 31