Session 1: Clinical trials of veterinary medicines
Moderator / Moderator: Zorana Radonjić, ALIMS
Procena za odobrenje veterinarskog kliničkog ispitivanja
Assessment for Authorisation of a Veterinary Clinical Trial
Sophie Barreteau, ANSES Francuska (online predavač) / ANSES France (online speaker)
Klinička ispitivanja: Gde smo i kuda idemo?
Clinical Trials: Where are we and where are we headed?
Jelena Anđelković, ALIMS
Studije neinferiornosti: Koliko loše je još uvek dobro?
Non-inferiority studies: How bad is still good enough?
Ivan Soldatović, Medicinski fakultet Univerziteta u Beogradu / University of Belgrade – Faculty of Medicine
11:00-11:30
Kafe pauza
Coffee break
11:30-13:00
Veterinarski lekovi: U susret novim izazovima
Sesija 2: Novine u regulativi
Veterinary medicines: Meeting new challenges
Session 2: News in regulation
Moderator / Moderator: Zorana Radonjić, ALIMS
RIMS i veterinarski lek
RIMS and veterinary drug
Milan Đokić, ALIMS Jelena Anđelković, ALIMS
Veterinarski lekovi za oralnu primenu - nove smernice
Veterinary drugs for oral use - new guidelines
Stefan Đurić, ALIMS
Varijacije EU/RS: (Ne)Usklađenost
Variations EU/RS:
Jelena Stevanović-Gročić, ALIMS
CEP 2.0 Šta nam donosi?
CEP 2.0 What does it bring us?
Aleksandra Labudović, ALIMS
13:00-15:00
Pauza za ručak
Lunch break
15:00-16:30
Procena i odobravanje kliničkih ispitivanja lekova
i medicinskih sredstava: zahtevi, proces i novine
Assessment and approval of clinical trials of medicines
and medical devices: requirements, processes and news
Moderator / Moderator: Biljana Andrić, ALIMS
Put od submisije do odobrenja - regulatorni zahtevi,
praktični aspekti i dosadašnja iskustva
Path from submission to approval - regulatory demands,
practical aspects and experiences
Biljana Latinović, ALIMS
Ključni aspekti procene dokumentacije
o kvalitetu ispitivanog leka (IMPD)
Key aspects in the evaluation of documentation
on the quality of tried drug (IMPD)
Katarina Todorović, ALIMS
Primena veštačke inteligencije u kliničkim ispitivanjima:
Izazovi i mogućnosti
Application of artificial intelligence in clinical trials:
Challenges and opportunities
Aleksandra Bjelovuk, ALIMS
Dubravka Mišković, ALIMS
Pregled regulatornih zahteva i aktivnosti ALIMS-a
iz oblasti kliničkih ispitivanja medicinskih sredstava
Overview of regulatory requirements and activities of ALIMS
in the field of clinical trials of medical devices
Sonja Selić, ALIMS
16:30-17:00
Kafe pauza
Coffee break
17:00-18:30
ICH E6(R3): Uspon profila
decentralizovanih kliničkih ispitivanja (DCT)
i odgovornosti – u susret izazovima
ICH E6(R3): The rising profile of
decentralized clinical trials (DCT)
and responsibilities - to meet the challenges
Moderator / Moderator: Violeta Ristić, ALIMS
Panelisti / Panelists: Siniša Radulović, Medicinski fakultet u Beogradu / University of Belgrade – Faculty of Medicine Ivana Tadić, PSI Iva Prunić, IQVIA