PROGRAM KONFERENCIJE / CONTENT OF CONFERENCE
| 17. april 2026. April 17th 2026 | METROPOL PALACE HOTEL, BELGRADE Ivo Andrić konferencijska sala / Ivo Andrić Conference Hall |
| Vreme / Time | Događaj / Event |
|---|---|
| 8:00 - 9:00 | Registracija učesnika / Registration of participants |
| 9:00 - 9:15 | Pozdravna reč / Opening session Konferansije / Narrator Dragan Vučelić |
| 9:15 - 10:35 | I SESIJA : EKSTERNE PROVERE SESSION I : EXTERNAL AUDITS Moderator / Moderator: Gordana Pejović, MediGroup, Srbija / MediGroup, Serbia |
| 9:15-9:35 | Provere od treće strane - Rizici i benefiti / Risks and benefits of 3rd party audits Assena Serbezova, Faculty of Public Health, Medical University-Sofia |
| 9:35-9:55 | Nova poglavlja i aneksi GMPa - izazovi u proveri / New chapters and annexes in GMP- challenges for audits Bruno Šimek, GxP Synapse, Croatia |
| 9:55-10:15 | Regulatorni zahtevi u svrhu izdavanja dozvole za distributere ljudskih tkiva i ćelija / The Regulatory Requirementsfor the Purpose of Issuing Human Tissue and Cells Licence for Pharmaceutical Wholesalers Anna Gavrilović, PHOENIX group, Tamro Eesti OÜ |
| 10:15-10:35 | Dobra praksa u farmakovigilanci i Dobra Distributivna Praksa: Ka regulatornom usklađivanju i zajedničkim ciljevima / Good Pharmacovigilance Practice and Good Distribution Practice: Towards Regulatory Alignment and Shared Objectives Nataša Knežević, Bonifar, Srbija/ Bonifar, Serbia |
| 10:35-10:50 | DISKUSIJA / DISCUSSION |
| 10:50-12:00 | PAUZA ZA KAFU / COFFEE BREAK |
| 12.00-13:20 | II SESIJA : INSPEKCIJE KOD NOSIOCA DOZVOLE SESSION II : INSPECTION AT MAH Moderator/Moderator: Sonja Bulajić, Institut za ljekove i medicinska sredstva Crne Gore (CInMED) / Institute for Medicines and Medical Devices of Montenegro (CInMED) |
| 12:00-12:20 | Regulatorni odgovor na krizu falsifikovanih lekova / The Regulatory Response to the Counterfeit Medicines Crisis, Pavle Zelić, Agencija za lekove i medicinska sredstva Srbije / Agency for Medicines and Medical Devices of Serbia |
| 12:20-12:40 | Aktivnosi inspektorata CInMED sa fokusom na inspekcijski nadzor u oblasti farmakovigilance / Activities of the CInMED inspectorate with a focus on inspection supervision in the field of pharmacovigilance Slađana Marsenić, Frosina Otašević, Institut za ljekove i medicinska sredstva Crne Gore (CInMED) / Institute for Medicines and Medical Devices of Montenegro (CInMED) |
| 12:40-13:00 | Reklamacije i povlačenja: zahtevi za MAH / Complaints and Recalls: Requirements for MAH Mirjana Dončeva, Agencija za lekove i medicinska sredstva Republike Severne Makedonije / Agency for Medicines and Medical Devices North Macedonia |
| 13:00-13:20 | Regulatorni okvir – primjena dermalnih filera u Bosni Hercegovini / Regulatory Framework - Application of Dermal Fillers in Bosnia and Herzegovina Dragana Reljić, Agencija za lijekove i medicinska sredstva BiH / Agency for Medicines anad Medical Devices B&H |
| 13:20-13:40 | DISKUSIJA / DISCUSSION |
| 13:40-15:00 | PAUZA ZA RUČAK / LUNCH BREAK |
| 15:00-16:00 | RADIONICA / WORKSHOP: KULTURA KVALITETA/QUALITY CULTURE Verica Dugan, Boehringer Ingelheim Serbia d.o.o. Beograd, Srbija / Boehringer Ingelheim Serbia d.o.o. Belgrade, Serbia Tatjana Bojanić, STADA/Hemofarm, Srbija / STADA/Hemofarm, Serbia Milica Đikić, ORGANON Srbija / ORGANON, Serbia |
| 16:00-17:30 | PANEL DISKUSIJA/PANEL DISCUSSION: TEMPERATURNA ODSTUPANJA / TEMPERATURE EXCURSIONS Moderator/Moderator: Valentina Marinković,Farmaceutski fakultet,Univerzitet u Beogradu / Faculty of Pharmacy, University of Belgrade, Serbia |
| 16:00-16:15 | Temperaturna odstupanja iz perspektive proverivača / Temperature excursions from auditors’ perspective Giovanni Di Luccio, GDP/GMP consultant, Italy |
| 16:15-16:30 | Upravljanje rizikom kod temperaturnih odstupanja / Risk management in case of temperature deviations Blagica Ingilizovska, Makedonijalek, Severna Makedonija / Makedonijalek, North Macedonia |
| 16:30-16:45 | Temperaturna odstupanja u distribuciji lekova i medicinskih sredstava/ Temperature excursions in the distribution of medicines and medical devices Olivera Pavlović Knežević, ADOC DOO, Srbija / ADOC DOO, Serbia |
| 16:45-17:00 | Temperaturna odstupanja u distribuciji suplemenata / Temperature excursions in the distribution of supplements Vesna Plamenac, Rhei Life, Srbija / Rhei Life, Serbia |
| 17:00-17:30 | PITANJA I ODGOVORI / Q&A session |
| 17:30 | ZAVRŠNA REČ / FINAL WORD |