10:00-11:30

Panel diskusija -
Praktični aspekti, izazovi i rešenja u primeni novih EU regulativa iz oblasti medicinskih sredstava u Republici Srbiji

Panel discussion -
Practical aspects, challenges and solutions in the application of new EU regulations in the field of medical devices in the Republic of Serbia

Moderator / Moderator:
Biljana Stojanović, ALIMS

Panelisti / Panelists:
Nađa Milojković, NeoMedica d.o.o. Niš ispred Grupacije proizvođača medicinskih sredstava, PKS / NeoMedica d.o.o. Nis,
representative of Group of producers of medical devices,
Chamber of commers of Serbia
Jelena Čolović, Medtronic Srbija d.o.o. ispred Grupacija uvoznika i distributera medicinskih sredstava, PKS / Medtronic Srbija d.o.o.
representative of Group of importers and distritubuters
of medical devices, Chamber of Commerce of Serbia
Vesna Ševaljević, MD&D Solutions
Vladimir Burgić, QMS Consulting

10:00-11:30

Paralelna sesija / Parallel session 

Sala Pogled / Hall Pogled

Rezultati projekta na
temu infodemije

Results of the
infodemic project

Moderator i predavač / Moderator & speaker:
Pavle Zelić, ALIMS

Predavači / Speakers:
Amy Rowland, Emory Global Health
Maja Bašić, HALMED
Stefan Mandić Rajević, Medicinski fakultet u Beogradu / University of Belgrade – Faculty of Medicine

11:30-12:00

Kafe pauza

Coffee break

12:00-13:30

Tragom globalnih trendova - od bioekvivalencije do međusobne zamenjivosti

Following global trends - from bioequivalence to mutual substitutability

Moderatori / Moderators:
Snježana Nikolić, ALIMS
Mladen Bogdanović, ALIMS

Abridged Application in the EU -
a regulatory perspective

Generički, hibridni i biološki sličan lek u EU - regulatorni aspekt

Ana Coelho, EMA

Međusobna zamjenjivost lijekova i novosti vezane za ICH smjernicu za ocjenu bioekvivalencije

Drug interchangeability and news related to the ICH guideline for bioequivalence assessment

Iva Klarica Domjanović, HALMED

Klinička ispitivanja lekova
ranih faza: šta je sa Srbijom?

Early phase clinical trials:
what about Serbia?

Viktorija Dragojević Simić, VMA /
Military Medical Academy

13:30-14:00

Zaključci simpozijuma

Symposium conclusions

14:00-16:00

Ručak

Lunch

Kraj simpozijuma

End of Symposium