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

  • Predavači / Lecturers:

  • 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

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

  • Predavači: / Lecturers:

  • 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

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

  • Predavači / Lecturers:

  • 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

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

  • Predavači / Lecturers:

  • 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

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

  • Predavači: / Lecturers:

  • 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

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

  • Predavači: / Lecturers:

  • 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

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