PROGRAM:
Prvi dan - 13.10.2023. / Day one - 13.10.2023.
09:00-10:30 - Registracija učesnika / Registration of the participants
09:00-10:30 - Koktel dobrodošlice / Welcome cocktail
10:30-11:00 (sala Izvor 1 i 2 / hall Izvor 1 i 2) - Otvaranje skupa i pozdravni govori / Opening ceremony and Welcome speeches
- Spec.dr.med. Saša Jaćović, direktor Agencije za lekove i medicinska sredstva Srbije – ALIMS / Sasa Jacovic, MD.Sp. director of the Medicines and Medical Devices Agency of Serbia – ALIMS
- Spec. dr med. Mirsad Đerlek, državni sekretar Ministarstva zdravlja Republike Srbije / Mirsad Đerlek MD.Sp., deputy Minister of Health of the Republic of Serbia
- Mag.farm. Mirjana Vučićević, pomoćnik direktora Sektora udruženja privrede i sekretar Udruženja za farmaciju i i medicinsku delatnost, Privredna komora Srbije / Mirjana Vučićević,MSc.Pharm., Assistant director of the Sector of Business Associations and Secretary of the Association for the Pharmaceutical and Medical Industry, Chamber of Commerce and Industry of Serbia
- Dr Bojan Trkulja, direktor Udruženja proizvođača inovativnih lekova Inovi / Bojan Trkulja, MD, director of the Association of Manufacturers of Innovative Medicines Inovia
- Dr Ana Popović, direktor Udruženja inostranih proizvođača generičkih lekova i nosilaca dozvola za stavljanje inostranih generičkih lekova u promet – Genezis / Ana Popović, MD, Director of the Association of Foreign Manufacturers of Generic Medicines and Holders of Marketing Authorization of Foreign Generic Medicines - Genezis
11:00-13:00 (sala Izvor 1 i 2 / hall Izvor 1 and 2) - Plenarna sesija: Globalna i Evropska regulatorna konvergencija i harmonizacija u oblasti lekova i medicinskih sredstava. / Plenary session: Global and European regulatory convergence and harmonization in the field of drugs and medical devices.
Sesija na engleskom jeziku / session in English
- Moderator/moderator: Mag.farm. Pavle Zelić, Agencija za lekove i medicinska sredstva Srbije - ALIMS / Pavle Zelić MSc.Pharm., Medicines and Medical Devices Agency of Serbia - ALIMS
- O čemu zaista govorimo kada govorimo o regulativi lekova i medicinskih sredstava? – interaktivno predavanje sa nagradama, Mag.farm. Pavle Zelić, Agencija za lekove i medicinska sredstva Srbije / What are we really talking about when we talk about regulating medicines and medical devices? – interactive lecture with prizes, Pavle Zelić MSc.Pharm., Medicines and Medical Devices Agency of Serbia
- Certificate of suitability new look: The CEP 2.0, Dr Igor Popović, Naučni referent, Odeljenje za sertifikaciju supstanci, Evropski direktorat za kvalitet lekova i brigu o zdravlju – EDQM Saveta Evrope / Certificate of suitability new look: The CEP 2.0 - Igor Popovic PhD, Scientific Officer, Certification of Substances Department - European Directorate for the Quality of Medicines and Health Care – EDQM of the Council of Europe –
- Predstavljanje Međunarodnog regulatornog foruma za medicinska sredstva - IMDRF – TBC/Presentation of the International Medical Devices Regulatory Forum – IMDRF – TBC
Predavači / Lecturers:
11:00-13:00 (sala Pogled / hall Pogled) - Lekovi za veterinarsku primenu - Aktuelnosti i Perspektive / Medicines for veterinary use
- Moderator - Dr sc Gordana M Žugić, Mr sc DVM, ALIMS
- Stočarstvo Srbije – Aktuelna situacija i perspektive, DVM Nenad Budimović, Privredna Komora Srbije
- Rizik od upotreba neregistrovanih vakcina protiv Afričke kuge svinja, Prof. dr Sonja Radojičić, Fakultet Veterinarske Medicine Univerziteta u Beogradu
- Translokacija rezultata pretkliničkih podataka na klinička ispitivanja, studije I faze, Prof. dr Zoran Todorović, Medicinski Fakultet Univerziteta u Beogradu
- Predklinička i klinička ispitivanja bezbednosti veterinarskih lekova, Prof. dr Saša Trailović, Fakultet Veterinarske Medicine Univerziteta u Beogradu
Predavači: / Lecturers:
13:00-14:30 - Pauza za ručak / Lunch break
14:30-16:30 (sala Izvor 2 / hall Izvor 2) - Nestašice lekova / Shortages of medicines
Sesija na engleskom jeziku / session in English
- Moderator: Prof. dr Sandra Vezmar Kovačević, Farmaceutski fakultet Univerziteta u Beogradu / Prof. Dr. Sandra Vezmar Kovačević, Faculty of Pharmacy, University of Belgrade
- Siofrad Mekmahon, Snabdevanje i dostupnost lekova i medicinskih sredstava (SAM), Radna grupa za regulatornu nauku i inovacije (TRS), Evropska agencija za lekove (EMA) / Síofradh McMahon, Supply and Availability of Medicines and Devices (SAM), Regulatory Science and Innovation Task Force (TRS), European Medicines Agency (EMA)
- Rita Pálffy-Poór PharmD, zamenik glavnog direktora za farmaciju, i Gyöngyi Petró ekspert NCA kontakt osoba za nestašice lekova, Nacionalni centar za javno zdravlje i farmaciju Mađarske / Rita Pálffy-Poór PharmD, Deputy Pharmaceutical Chief Officer, and Gyöngyi Petró expert NCA contact person on Drug Shortages, National Center for Public Health and Pharmacy of Hungary
- Radoslav Ruičev, glavni inspektor, Bugarska agencija za lekove / Radoslav Ruitchev, Chief Inspector, Bulgarian Drug Agency
Predavači / Lecturers:
14:30-16:30 (sala Izvor 1 / hall Izvor 1) - Sistem vigilance medicinskih sredstava u praksi - Uloga koordinatora za vigilancu u zdravstvenoj ustanovi i prijavljivanje neželjenih reakcija / The medical devices vigilance system in practice - The role of the coordinator for vigilance in a health care facility and the reporting of adverse reactions
- Moderator: Aleksandra Vujačić Simić
- Dragoljub Pavlović, mag. farmacije, sanit. ing., spec. tehnologije, Prospera
- Jasna Stojković, mag. farmacije, koordinator za vigilancu, KBC „Dr Dragiša Mišović Dedinje“
- Nikola Rosić spec. Kliničke farmacije, zamenik koordinatora za vigilancu, UKC Kragujevac
- Sonja Bošković, Senior Specialist, Regulatory Affairs Region East Non-EU countries, International Regulatory Affairs Core Diagnostics, Abbott Laboratories
- Tatjana Stevanović, Procenitelj dokumentacije za medicinska sredstva, ALIMS
Predavači / Lecturers:
14:30 - 16:30 (sala Pogled / hall Pogled) - Lekovi za veterinarsku primenu - Aktuelnosti i Perspektive - drugi deo / Medicines for veterinary use
- Moderator: Dr sc Gordana Žugić, Mr sc DVM, ALIMS
- Inovacije i digitalna transformacija ALIMS-a za veterinarske lekove,Doc dr Tatjana Stojadinović,ALIMS
- CPP Sertifikat – način podnošenja,DVM Jelena Anđelković, ALIMS
- Obezbeđenje kvaliteta – uticaj kvaliteta veterinarskog leka na koncept jedno zdravlje Prof. dr Svetlana Ibrić, Farmaceutski fakultet Univerziteta u Beogradu
- GMP u susret kvalitetu – regulatorni aspekt, Dipl. farm. Aleksandra Labudović, ALIMS
Predavači: / Lecturers:
16:30 - 17:00 - Pauza / Break
17:00 - 19:00 (sala Izvor 2 / hall Izvor 2) - Aktuelne tendencije u farmakovigilanci – kuda idemo / Current trends in pharmacovigilance - where are we going
Sesija na engleskom jeziku / session in English
- Moderator:Marko Erić, ALIMS
- Farmakovigilanca u EU i nove tendencije - Margarida Guimaraes, Evropska agencija za lekove (EMA) / Pharmacovigilance in the EU and the new directions-Margarida Guimaraes, European Medicines Agency (EMA)
- Izazovi u farmakovigilanciji s aspekta zemlje članice EU - Petar Mas, Agencija za lekove i medicinska sredstva Hrvatske - HALMED / Challenges in pharmacovigilance from the EU member state perspective - Petar Mas, Agency for Medicines and Medical Products of the Republic of Croatia – HALMED
- Može li AI da uvede revoluciju u farmakovigilancu? Uspon mašina... - dr David Lewis, Head QPPV PRRC Office / Can AI Revolutionise Pharmacovigilance? The Rise of the Machines...dr David Lewis, Head QPPV PRRC Office Visiting Professor, School of Life and Medical Sciences, University of Hertfordshire
Predavači: / Lecturers:
17:00 - 19:00 (sala Izvor 1 / hall Izvor 1) - Kontinuirano praćenje medicinskog sredstva na tržistu, surveillance – praktični aspekti usaglašavanja sa EU smernicom iz oblasti surveillance / Continuous monitoring of the medical device on the market, surveillance - practical aspects of compliance with the EU directive in the field of surveillance
Moderator:Mag.farm. Aleksandra Vujačić Simić, ALIMS
Predavači: / Lecturers:
- Vesna Ševaljević, Associate Director Regulatory Consulting, GRAS, Syneos Health
- Aleksandra Vujačić Simić, Rukovodilac Sektora za medicinska sredstva, ALIMS
- Danilo Rajković, International Certification Group
19:00-21:00 - Večera / Dinner
22:00-03:00 - restoran Nacionalna klasa / restaurant National class Koktel / Cocktail party
Drugi dan - 14.10.2023. / Day two - 14.10.2023.
09:00-11:00 (sala Izvor 2 / hall Izvor 2) - Radionica: “Reliance” pristup u proceni dokumentacije o leku i druge novine / Workshop: "Reliance" approach in evaluating medicines documentation and other novelties
Prevod na engleski jezik / translation to English
Moderator: Marija Malešević, ALIMS
Predavači / Lecturers:
- BCS-based biowaiver - Prof. dr Svetlana Ibrić, Farmaceutski fakultet Univerziteta u Beogradu / BCS-based biowaiver - lecturer: prof. dr Svetlana Ibrić, Faculty of Pharmacy, University of Belgrade
- “Reliance” pristup u proceni dokumentacije o leku - Marina Milanović, ALIMS i Dragana Avakumović, ALIMS / “Reliance”approach in evaluating medicines documentation - lecturer: Marina Milanović, ALIMS and Dragana Avakumović, ALIMS
Drugi deo - Novine u proceni kvaliteta aktivne supstance i gotovog leka / Second part -Novelties in the evaluation of the quality of the active substance and the finished medicine
Predavači: / Lecturers:
- Genotoksične nečistoće - Nitrozamini…priča koja se nastavlja - Marija Čarapić, ALIMS / Genotoxic impurities - Nitrosamines…the continuing story - Marija Čarapić, ALIMS
- Dissolution test za čvrste farmaceutske oblike - novine - Tanja Vidojević, ALIMS / Dissolution test for solid pharmaceutical forms - novelties - Tanja Vidojević, ALIMS
09:00-11:00 (sala Izvor 1 / hall Izvor 1) - Kontrola kvaliteta leka u Republici Srbiji / Medicines quality control in the Republic of Serbia
Moderator: Katica Drljević Đurić, ALIMS
Predavači / Lecturers:
Uloga NKL u kontroli kvaliteta leka u Republici Srbiji - Svjetlana Mihaljica, ALIMS / The role of National Control Laboratory NCL in medicines quality control in the Republic of Serbia -Svjetlana Mihaljica, ALIMS
Proces laboratorijskog ispitivanja leka u NKL - Od prijema zahteva do izdavanja sertifikata - Aleksandra Đurđević, ALIMS / The process of laboratory testing of the medicines in NCL - From the receipt of the request to the issuance of the certificate - Aleksandra Đurđević, ALIMS
Notifikacije o promeni dizajna pakovanja lekova koje ne zahtevaju prijavu varijacije - Katica Drljević Đurić, ALIMS / Notifications on changes in the design of medicines packaging that do not require notification of a variation - Katica Drljević Đurić, ALIMS
11:00-11:30 - Pauza za kafu / Break
11:30-13:30 (sala Izvor 2 / hall Izvor 2) - Radionica: Izdavanje dozvole na neograničeno vreme – zahtevi i iskustva / Workshop: Issuance of a permanent license – requirements and experience
Prevod na engleski jezik/ translation to English
Moderator: Ivana Džunić, ALIMS
Predavači / Lecturers:
- Sofija Pendić, ALIMS
- Daliborka Tišić, ALIMS
- Aleksandra Marsenić, ALIMS
- Jelena Mitrašinović, ALIMS
11:30-13:30 (sala Izvor 1 / hall Izvor 1) Izazovi u komunikacijama i transparentnosti u javnom zdravlju na Evopskom i nacionalnom nivou / Challenges in communications and transparency in public health at the European and national level
Sesija na engleskom jeziku / session in English
Moderator: Prof. dr Dušanka Krajnović,Farmaceutski fakultet Univerziteta u Beogradu / Prof. Dr. Dušanka Krajnović, Faculty of Pharmacy, University of Belgrade
Predavači / Lecturers:
- Thanas Goga, tehnički službenik (RCI), komunikacija o rizicima, angažovanje zajednice i upravljanje infodemijom, VHE Balkan Hub | Regionalna kancelarija SZO za Evropu / Thanas Goga, Technical Officer (RCI), Risk Communication, Community Engagement & Infodemic Management, WHE Balkan Hub | WHO Regional Office for Europe
- Dr Aleksandar Stevanović, saradnik u nastavi Katedre za socijalnu medicinu, Medicinskog fakulteta Univerziteta u Beogradu, Laboratorija za infodemiju / Dr. Aleksandar Stevanović, teaching assistant at the Department of Social Medicine, Faculty of Medicine, University of Belgrade, Laboratory for Infodemiology
- Maja Bašić, glasnogovornik Agencije za lijekove i medicinske proizvode Republike Hrvatske – HALMED / Maja Bašić, spokesperson for the Agency for Medicines and Medical Products of the Republic of Croatia – HALMED
13:30-15:00 - Pauza za ručak / Lunch break
15:00-17:00 (sala Izvor 2 / hall Izvor 2) - Panel diskusija – Registracija, produženje registracije, izmene i dopune registracije medicinskih sredstava, sa posebnim akcentom na izazove nastale usled primene novih EU regulativa / Panel discussion - Registration, extension of registration, changes and additions to the registration of medical devices, with special emphasis on challenges arising from the application of new EU regulations
Moderator: Ružica Damjanović, ALIMS
Panelisti / Panelisti:
- Vladimir Burgić, HUMAN Medical Solutions, u ime Grupacije proizvođača medicinskih sredstava Privredne komore Srbije (PKS) / Vladimir Burgić, HUMAN Medical Solutions, on behalf of the Group of Manufacturers of Medical Devices of the Chamber of Commerce and Industry of Serbia (PKS
- Katarina Kovačević, direktor KK Pharma Leader d.o.o, u ime Grupacije uvoznika i distributera medicinskih sredstava Privredne komore Srbije (PKS) / Katarina Kovačević, CEO of KK Pharma Leader d.o.o, on behalf of the Group of Importers and Distributors of Medical Devices of the Chamber of Commerce and Industry of Serbia (PKS)
- Biljana Stojanović, Procenitelj dokumentacije medicinskih sredstava, ALIMS / Biljana Stojanović, Evaluator of documentation of medical devices, ALIMS
15:00-17:00 (sala Izvor 1 / hall Izvor 1) - Farmaceutski zločin / Pharmaceutical crime
Sesija na engleskom jeziku / session in English
Moderator: Mag.farm. Pavle Zelić, ALIMS / Pavle Zelić MSc.Pharm., ALIMS
Predavači / Lecturers:
- Koncept farmaceutskog zločina u teoriji i praksi - Dr. Roni Berkovitz, direktor Jedinice za sproviđenje, Ministarstvo zdravlja Izraela / Concept of pharmaceutical crime in theory and practice - Ph.D. Ronny Berkovitz, Director of the Enforcement Unit, Ministry of Health of Israel
- Predstavljanje rezultata MEDI THEFT projekta - Dr Domenico Di Giorgio, odeljenje za inspekciju i sertifikaciju, šef kancelarije, Italijanska agencija za lekove - AIFA / Presentation of the results of the MEDI THEFT project - Dr. Domenico Di Giorgio, Inspection and Certification Department, Head of office, Italian Medicines Agency - AIFA
- Izazovi serijalizacije u EU - Radoslav Ruičev, glavni inspektor, Bugarska agencija za lekove - BDA / Challenges of Serialization in EU - Radoslav Ruitchev, Chief Inspector, Bulgarian Drug Agency
- Nestandardni i falsifikovani medicinski proizvodi: Obim, razmere i šteta – centrala Svetske zdravstvene organizacija - SZO – TBC / Substandard and falsified medical products: Scope, scale and harm – World Health Organization WHO HQ – TBC
17:00-17:30 - Zaključci simpozijuma / Conclusions of the Symposium (Sala Izvor 1 i 2 / hall Izvor 1 i 2)
17:30 Kraj simpozijuma / End of symposium