PROGRAM:

Prvi dan - 21.10.2022. / Day one - 21.10.2022.

od 09:00 - Registracija učesnika / Registration of the participants

od 09:00-10:15 - Koktel dobrodošlice / Welcome cocktail

10:15-10:45 (velika sala) - Otvaranje skupa i pozdravni govori / Formal opening of the event and welcome speeches

11:00-13:00 (velika sala) - Kolaborativne registracione procedure (CRP) - osnovne karakteristike, iskustva i značaj / Collaborative Registration Procedures (CRP) - basic characteristics, experiences and importance

11:00-13:00 (srednja sala) - Saradnja veterinarske i humane medicine kao alat za unapređenje javnog zdravlja / Cooperation between veterinary and human medicine as a tool for improving public health

  • Rezidue antibiotika i hormona u namirnicama životinjskog porekla / Residues of antibiotics and hormones in foods of animal origin
  • Primena psihoaktivnih supstanci u veterinarskoj medicini / Use of psychoactive substances in veterinary medicine
  • Značaj bezbednog uklanjanja humanih i veterinarskih lekova i njihovih rezidua-uticaj na ekosistem / The importance of safe disposal of human and veterinary medicines and their residues - impact on the ecosystem
  • Ograničenje primene titan-dioksida (E171) u lekovima / Restriction of the use of titanium dioxide (E171) in medicines

13:00-14:30 - Pauza za ručak / Lunch break

14:30-16:30 (velika sala - lekovi) - Najčešća pitanja, nedoumice i primena važećih propisa i smernica u regulatornim postupcima dozvole za lek - prvi deo / The most frequent questions, doubts and the application of valid regulations and guidelines in the regulatory procedures of the marketing authorization - part one

  • Kako obezbediti formalnu kompletnost zahteva za izdavanje/obnovu dozvole: primeri iz prakse / How to ensure the formal completeness of the request for the issuance/renewal of the marketing authorization: examples from practice
  • Zajedničkim snagama do visokog kvaliteta dokumentacije Modula 3: Kako da zajedničkim radom i saradnjom savladamo najčešće nedoumice i pitanja u dokumentaciji o kvalitetu leka? / Joining forces towards high quality documentation of Module 3: How can we overcome the most common doubts and questions in the documentation about the quality of medicine through joint work and cooperation?

14:30-16:30 (velika sala - medicinska sredstva) - Medicinska sredstva – izazovi u svetlu novih EU regulative / Medical devices - challenges in the light of new EU regulations

  • Uvođenje nove nomenklature medicinskih sredstava (Grupa generičkih medicinskih sredstava) – usklađivanje sa EU regulativama / Introducing a new nomenclature of medical devices (Group of generic medical devices) - alignment with EU regulations
  • Integrisanje Evropske nomenklature medicinskih sredstava (EMDN) (European Medical Device Nomenclature) u IS Agencije / Integrating the European Medical Device Nomenclature (EMDN) into the Agency's ISIntegrating the European Medical Device Nomenclature (EMDN) into the Agency's information system
  • Prevod Evropske nomenklature medicinskih sredstava – EMDN – SRB (integracija dvojezičnog naimenovanja srpski/engleski, sa šiframa) / Translation of the European Nomenclature of Medical Devices - EMDN - SRB (integration of Serbian/English bilingual nomenclature, with codes)
  • Mapiranje postojeće Baze medicinskih sredstava ALIMS: „Grupa generičkih medicinskih sredstava“ / Mapping of the existing Medical Device Database of ALIMS: "Group of Generic Medical Devices"
  • Registracija medicinskih sredstava – usklađivanje sa novom nomenklature medicinskih sredstava (EMDN – SRB) / Registration of medical devices - alignment with the new nomenclature of medical devices (EMDN - SRB)
  • Proizvođači medicinskih sredstava u Republici Srbiji – put usaglašavanja sa osnovnim zahtevima za medicinska sredstva: CE znak ili srpski znak usaglašenosti / Manufacturers of medical devices in the Republic of Serbia - the path to compliance with the basic requirements for medManufacturers of medical devices in the Republic of Serbia - the path to compliance with the basic requirements for medical devices: CE mark or Serbian mark of conformity
  • Uloga Imenovanog tela u Republici Srbiji u postupku usaglašavanja sa osnovnim zahtevima za medicinska sredstva / The role of the Appointed Body in the Republic of Serbia in the process of compliance with the basic requirements for medical devices

14:30-16:30 (srednja sala) - Monoklonska antitela u veterinarskoj medicini / Monoclonal antibodies in veterinary medicine

  • Primena monoklonskih antitela u veterinarskoj medicini / Application of monoclonal antibodies in veterinary medicine
  • Regulatorni zahtevi za pripremu dokumentacije za registraciju monoklonskih antitela koja se primenjuju u veterinarskoj medicini / Regulatory requirements for the preparation of documentation for the registration of monoclonal antibodies used in veterinary medicine
  • Regulatorni zahtevi za pripremu dokumentacije za registraciju veterinarskog leka / Regulatory requirements for the preparation of documentation for the registration of a veterinary medicine

16:30-17:00 - Kafe pauza / Break

17:00-19:00 (velika sala - lekovi) - Najčešća pitanja, nedoumice i primena važećih propisa i smernica u regulatornim postupcima dozvole za lek - drugi deo / The most frequent questions, doubts and the application of valid regulations and guidelines in the regulatory procedures of the marketing authorization - part two

  • Regulatorni zahtevi u suštinskoj proceni efikasnosti i bezbednosti leka / Regulatory requirements in the essential evaluation of medicines efficacy and safety
  • Farmakovigilanca - zahtevi i iskustva / Pharmacovigilance - requirements and experiences
  • Regulatorni zahtevi, praktični aspekti i dosadašnja iskustva u proceni SmPC, PIL i Teksta pakovanja u svrhu izdavanja/obnove dozvole za lek / Regulatory requirements, practical aspects and past experiences in the assessment of SmPC, PIL and Package Text for the purpose of issuing/renewing a marketing authorization of a medicine

    • 17:00-19:00 (velika sala - medicinska sredstva) -PANEL DISKUSIJA – praktični aspekti primene novih EU regulativa – dosadašnja iskustva i predlozi za unapređenje; iskustva EU proizvođača / PANEL DISCUSSION - practical aspects of the application of new EU regulations - past experiences and suggestions for improvement; experiences of EU producers

    • EU tranzicioni periodi propisani MDR/IVDR (Declaration of Conformity, EC-Certificates, UDI, Medical Devices Labeling) - usaglašenost regulative RS iz oblasti medicinskih sredstava – praktični primeri neduomica u postupcima registracije, produženja registracije i izmena i dopuna registracije medicinskih sredstava / EU transition periods prescribed by MDR/IVDR (Declaration of Conformity, EC-Certificates, UDI, Medical Devices Labeling) - compliance with Republic of Serbia regulations in the field of medical devices - practical examples of doubts in the procedures of registration, an extension of registration, and changes and additions to the registration of medical devices

    17:00-19:00 (srednja sala) - Sesija: Predstavljanje MEDI-THEFT projekta na temu krađa lekova, i borba protiv zloupotrebe, ilegalnog prometa i falsifikovanja lekova i medicinskih sredstava / Presentation of the MEDI-THEFT project on the topic of theft of medicines, and the fight against abuse, illegal traffic and counterfeiting of medicines and medical devices

    19:00-21:00 - Večera / Dinner

    22:00-02:00 - Proslava / Coctail reception

    Drugi dan - 22.10.2022. / Day two - 22.10.2022.

    09:00-09:30 - Kafe pauza / Break

    09:30-11:00 (velika sala - lekovi) - Aktuelni regulatorni zahtevi u proceni dokumentacije o kvalitetu leka / Current regulatory requirements in the evaluation of documentation on the quality of the medicines

    • Čemu služi baza standardnih termina EDQM? Primena u postupku izdavanja dozvole za lek i sistem identifikacije medicinskih proizvoda / What is the EDQM standard terms database used for? Application in the process of issuing a marketing authorizationf for a medicine and the medical product identification system
    • Elementalne nečistoće - kontrolna strategija i aktuelni regulatorni zahtevi / Elemental impurities - control strategy and current regulatory requirements

    09:30-11:00 (srednja sala) - Stručne publikacije ALIMS-a – doprinos unapređenju farmakoterapije / Professional publications of ALIMS - contribution to the improvement of pharmacotherapy

    11:00-11:30 - Pauza za kafu / Break

    11:30-13:30 (velika sala) - Panel: Upravljanje krizama i rizicima kroz strateške i operativne komunikacije – od sprečavanja dezinformacija do budućih pandemija / Panel: Crisis and risk management through strategic and operational communications - from disinformation prevention to future pandemics

    11:30-13:30 (velika sala - klinička ispitivanja) - Klinička ispitivanja – regulatorni zahtevi i njihov uticaj na sprovođenje u Republici Srbiji - prvi deo / Clinical trials - regulatory requirements and their impact on implementation in the Republic of Serbia - part one

    • Regulatorni okviri u postupku odobravanja sprovođenja kliničkih ispitivanja u Republici Srbiji / Regulatory frameworks in the procedure for approving the conduct of clinical trials in the Republic of Serbia

    13:30-15:00 - Pauza za ručak / Lunch break

    15:00-17:00 (velika sala) - Kontrola kvaliteta lekova i regulatorni zahtevi / Medicines quality control and regulatory requirements

    • Zahtevi za standardne supstance u postupku kontrole kvaliteta leka / Requirements for standard substances in the medicines quality control procedure
    • 11. izdanje Evropske farmakopeje – U susret novim zahtevima / 11th edition of the European Pharmacopoeia - Meeting new requirements
    • Identifikacija i upravljanje OOT i OOS rezultatima / Identification and management of OOT and OOS results

    15:00-17:00 (velika sala - klinička ispitivanja) - Klinička ispitivanja – regulatorni zahtevi i njihov uticaj na sprovođenje u Republici Srbiji - drugi deo / Clinical trials - regulatory requirements and their impact on implementation in the Republic of Serbia - part two

    • Uticaj lokalne regulative na sprovodjenje kliničkih ispitivanja – značaj i posledice (poseban osvrt na zaštitu ličnih podataka) / The influence of local regulations on the conduct of clinical trials - importance and consequences (special reference to the protection of personal data)

    17:00-17:30(velika sala) - Zaključci simpozijuma / Conclusions of the symposium

    Kraj simpozijuma / End of symposium