9:30-11:00

RIMS - Sledeća ALIMS generacija

RIMS - ALIMS Next Generation

Moderatori / Moderators:
Marko Erić, ALIMS
Tanja Neđić, ALIMS

ALIMS digitalna transformacija
i RIMS revolucija

ALIMS digital transformation
and RIMS revolution

Predavači / Speakers:
Marko Erić, ALIMS
Tatjana Stojadinović, ALIMS

Putokaz u eBudućnost -
panel diskusija

Pathway to eFuture -
panel discussion

Panelisti / Panelists:
Svetlana Jovanović,
Fakultet organizacionih nauka / The Faculty of Organisational Sciences
Tatjana Stojadinović, ALIMS
Tijana Radojičić, PKS / Chamber of commerce of Serbia
Zoran Dobrosavljević, Abstract
Marko Erić, ALIMS

11:00-11:30

Kafe pauza

Coffee break

11:30-13:00

Umrežavanje u oblasti regulative i kontrole - značaj saradnje sa međunarodnim i nacionalnim institucijama u obezbeđivanju kvalitetnih lekova

Networking in regulation and control - importance of collaboration with international and national institutions in acquiring quality drugs

Moderator / Moderator:
Marija Malešević, ALIMS

Povlačenje leka iz prometa - Nacionalna i međunarodna saradnja u postupku povlačenja

Medicine recall from the market - National and international cooperation in the recall process

Svjetlana Mihaljica, ALIMS

Iskustva NKL u okviru OMCL mreže

NCL Experience within OMCL Network

Katica Drljević Đurić, ALIMS

Novi zahtevi u kvalitetu aktivne supstance i učešće ALIMS-a u CEP procedure

New requirements for the quality of active substance and ALIMS participation in the CEP procedure

Marija Čarapić, ALIMS

Značaj kvaliteta i ispitivanja ekscipijenasa u formulaciji leka: da li su ekscipijensi samo pomoćne materije?

Significance (Awareness) of quality and testing of excipients in drug formulation: Are excipients just auxiliary substances?

Stana Ubavić, ALIMS

13:00-15:00

Pauza za ručak

Lunch break

15:00-16:30

Regulatorni reliance: sadašnja praksa i buduće perspektive

Regulatory Reliance: Current Practice and Future Perspectives

Moderator / Moderator:
Dragana Avakumović, ALIMS

Panelisti / Panelists:
Marija Malešević, ALIMS
Biljana Tubić, ALMBIH
Gordana Boljević Stanojević, CinMED
Ivana Ferber, MSD Hrvatska / MSD Croatia
Ana Coelho, EMA

16:30-17:00

Kafe pauza

Coffee break

17:00-18:30

Aktuelne teme iz oblasti regulative medicinskih sredstava, sa osvrtom na

  • regulatorne zahteve u delu prometa i proizvodnje medicinskih sredstava u Republici Srbiji
  • uspostavljanja sistema menadžmenta kvalitetom (ISO 13485)
  • ocenjivanja usaglašenosti medicinskih sredstava u Republici Srbiji (srpski znak usaglašenosti)

Current topics in the field regulation of medical devices, with reference to

  • regulatory requirements in the area of marketing and production of medical devices in the Republic of Serbia
  • establishing a management system for quality (ISO 13485)
  • conformity assessment of medical devices in the Republic of Serbia (Serbian mark of conformity)

Moderator / Moderator:
Aleksandra Vujačić Simić, ALIMS

Regulatorni zahtevi u oblasti prometa i proizvodnje medicinskih sredstava u Republici Srbiji

Regulatory requirements in the field of circulation & production of medical devices in the Republic of Serbia

Marija Kurćubić, Ministarstvo zdravlja Republike Srbije / Ministry of Health of Republic of Serbia

Regulatorni zahtevi za stavljanje na tržište "DDC (Drug-Device combination)" proizvoda

Regulatory requirements for placing "DDC (Drug-Device combination)" products on the market

Vesna Ševaljević, MD&D Solutions

Ocenjivanje usaglašenosti medicinskih sredstava za svrhe dobijanja 3A znaka (srpski znak usaglašenosti) - osvrt iz ugla imenovanog tela

Assessment of the conformity of medical devices for the purposes of obtaining the 3A mark (Serbian mark of conformity) - a review from the designated body point of view of

Ivan Popović, Kvalitet AD Niš

Značaj uspostavljanja sistema menadžmenta kvalitetom - medicinska sredstva (ISO 13485)

The importance of establishing a quality management system - medical devices (ISO 13485)

Vladimir Burgić, QMS Consulting

18:30-21:00

Večera u restoranu hotela Gorski

Dinner at hotel Gorski

21:00

Koktel - restoran Nacionalna klasa

Cocktail - Restaurant "Nacionalna Klasa"

7. kongres hitne medicine