• MPharm., Predrag Ristić

    • Pharmillennium Consulting d.o.o., CEO

As former Deputy General Manager at the Institute of Pharmacy & Head of National Control Laboratory (at the present days - Agency for Medicines and Medical Devices of the Republic of Serbia) he was responsible for release of batches of medicines which were subject to mandatory QC by NCL in former Yugoslavia and then, in Serbia. He was managing complete NCL work including physico-chemical, instrumental, microbiology and virology laboratories and gained strong experience in QC laboratory operations, as well as in evaluation of the Quality part of registration dossiers for all kinds of medicines, MDs and supplements. As IT expert, he’s managed development and implementation of the ERP and LIMS at the Institute and established the first paperless operational IT system in NCL. He participated in defining national Health policies, systems, regulation development, harmonization and implementation of EU legislation and ICH guidelines. He participated in GMP audits of the manufacturing sites. As former Adviser to the Minister of Health and Minister of Agriculture of the Republic of Montenegro, he’s provided consulting services in establishing 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 human and veterinary medicines, as well as in restructuring health care system. He has published 2 books, 2 monographs and over 50 scientific articles.

As shareholder, CEO at Pharmillennium Consulting d.o.o. he 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 audits of final product 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, validation of computerised systems, designing and implementation of specialised IT solutions for manufacture of medicines, QC laboratories and medical laboratories, VMPs, qualifications and validations, etc. He’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.

PharMillennium Consulting d.o.o.
Company Register: 50053901
VAT No. 02314240

Registered Address:
Obala Crvenih mornara bb.
85345 Djenovići, Herceg Novi
Montenegro

Post Address:
Sunčana Obala 152
85346 Zelenika, Herceg Novi
Montenegro

Office Belgrade Address:
Cara Uroša 12, ground floor
11000 Belgrade

Email: office@pharmillennium.com
Phone:   +381 11 408 69 05
                +381 11 408 68 79
Mobile:   +381 64 832 85 98