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Do 17. Simpozijuma još:


Raspored sesija

Prvi dan / Day one:

Prvi dan/Day one

 Petak, 26novembar 2021. / Friday, November 26th, 2021

09:00-10:00

Priključivanje učesnika / Open connections for participants

10:00-10:30

Otvaranje skupa, pozdravni govori / Opening of the meeting, Welcome speeches (samo na srpskom jeziku/only in Serbian language):

-  Dr Saša Jaćović direktor ALIMS
-  Bojan Trkulja, direktor udruženja Inovia
-  Ana Popović, direktor udruženja Genezis
-  Sanda Savić, predsednik Odbora udruženja za farmaciju i medicinsku delatnost PKS
-  Prof. dr Predrag Sazdanović, državni sekretar - predstavnik Ministarstva zdravlja Republike Srbije

10:30-11:30

Plenarna predavanja / Plenary lectures (samo na srpskom jeziku/only in Serbian language):

Moderator: Jadranka Mirković, ALIMS

• Na
čin organizacije rada anesteziologa u Kovid Jedinicama intenzivnog lečenja Srbije - 20 meseci iskustva / Method of organizing the work of anesthesiologists in COVID Intensive Care Units of Serbia - 20 months of experience – Prof. dr Nebojša Lađević, direktor Centra za anesteziologiju Kliničkog centra Srbije i koordinator svih bolnica u Srbiji / Head of the Center for Anesthesiology of the Clinical Center of Serbia and coordinator of all hospitals in Serbia

• COVID-19 – patogeneza i terapijski pristup / COVID-19 - pathogenesis and therapeutic approach - Prof. dr Radmilo Janković, zamenik direktora Kliničkog centra Niš / Deputy Director of the Clinical Center Nis

• Značaj tromboprofilakse kod COVID-19 pozitivnih pacijenata / Significance of thromboprophylaxis in COVID-19 positive patients - Doc. dr Darko Antić, direktor klinike za hematologiju Kliničkog centra Srbije / Head of the Clinic for Hematology of the Clinical Center of Serbia

11:30-12:00

Pauza / Break

12:00-14:00

I sesija/session: Panel diskusija/panel discussion (isključivo na engleskom jeziku/only in English):
Suočavanje regulatornih autoriteta sa COVID-19 pandemijom sa aspekta humanih lekova i medicinskih sredstava – visoki predstavnici ALIMS i regulatornih tela iz drugih zemalja /
Confrontation of regulatory authorities with the COVID-19 pandemic in terms of medicines and medical devices for human use - the high representatives of ALIMS and regulatory bodies from other countries.

Moderator: Pavle Zelić, ALIMS

Panelisti / Panelists:

Dr Domenico Di Giorgio, AIFA, Agencija za lekove Italije – AIFA / Italian Medicines Agency – AIF
Momir Radulović, JAZMP, Slovenija / Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Maja Bašić, Agencija za lijekove i medicinske proizvode – HALMED, Hrvatska / The Agency for Medicinal Products and Medical Devices of Croatia
Ji-hye Jeong, Ministarstvo za hranu i Bezbednost lekova, Južna Koreja / The Ministry of Food and Drug Safety (MFDS) South Korea,
Mkrtich Shakaryan,  Ministarstvo zdravlja, Jermenija / Ministry of Health, Armenia,
Petró Gyöngyi,  Nacionalni Institut za Farmaciju, Mađarska / National Instititue of Pharmacy, Hungary,
Dr Snežana Mugoša,  Institut za ljekove i medicinska sredstva Crne Gore / Institute for medicines and medical devices of Montenegro.
Biljana Tubić, Agencija za ljekove i medicinska sredstva Bosne i Hercegovine - ALMBIH/Agency for Medicinal Products and Medical Devices ofBosnia and Herzegovina – ALMBIH
Maria Vasilescu, Nacionalna Agencija za lekove i medicinska sredstva Rumunije – ANMDM/National Agency for Medicines and Medical Devices of Romania – ANMDM
Roxana Fizesan, Nacionalna Agencija za lekove i medicinska sredstva Rumunije – ANMDM/National Agency for Medicines and Medical Devices of Romania – ANMDM

14:00-15:00

Pauza/Break

15:00-17:00

II sesija/session (Isključivo na srpskom jeziku / Only in Serbian language):
Medicinska sredstva u Srbiji u vreme pandemije
/ Medical devices in Serbia during pandemic

Moderator:
Aleksandra Vujačić Simić, ALIMS

Branislav Radivojević, ALIMS

Iskustva u pogledu borbe protiv COVID-19 sa aspekta medicinskih sredstava – nabavka neophodne zaštitne opreme (maske, rukavice), dijagnostike (testovi) i terapeutskih sredstava (respiratori) kao i detalji oko organizovanja rada ALIMS u vreme pandemije vezano za medicinska sredstva / Lecture: Experiences in the fight against COVID-19 from the aspect of medical devices - procurement of necessary protective equipment (masks, gloves), diagnostics (tests) and therapeutic devices (respirators) as well as details about organizing ALIMS work during the pandemic related to medical devices. - Branislav Radivojević,  ALIMS

Aktuelne teme u pogledu regulative medicinskih sredstava u Srbiji / Lecture: Current topics regarding the regulation of medical devices in Serbia - Aleksandra Vujačić Simić, ALIMS

ORGANIZATORI ZADRŽAVAJU PRAVO IZMENE PROGRAMA
THE ORGANIZERS RESERVE THE RIGHT TO CHANGE PROGRAM

Simpozijum se organizuje u skladu sa svim važećim merama i preporukama u pogledu zaštite zdravlja učesnika od zaraze SARS-CoV-2 virusom
The symposium is organized in accordance with all official measures and recommendations regarding the protection of the health of participants from SARS-CoV-2 virus infection.

Drugi dan/Day

Drugi dan / Day two

Saturday, 27novembar 2021. / Saturday, November27th, 2021

09:00-10:00

Priključivanje učesnika / Open connections for participants

10:00-12:00

III sesija / session (samo na srpskom jeziku / only in Serbian language) – Predavanja i panel diskusija sa predstavnicima ALIMS i sva tri koorganizatora – prvi deo:
Dosadašnja iskustva, praktična pitanja, predlozi za unapređenje i komunikacije vezano za Pravilnik o sadržaju zahteva i dokumentacije, kao i načinu dobijanja dozvole za stavljanje leka u promet
/ Lectures and panel with representatives of ALIMS and all three co-organizers - first part: Previous experiences, practical issues, suggestions for improvement and communications relatedto the Rulebook on the content of applications and documentation, as well as the method of obtaining a marketing authorization

Moderatori:
Jadranka Mirković, ALIMS
Ivana Džunić, ALIMS

- COVID-19: Regulatorni i proceduralni izazovi i iskustva / COVID-19: Regulatory and Procedural Challenges and Experiences – Jadranka Mirković, ALIMS
- Pitanja i izazovi prilikom podnošenja zahteva i formalne procene dokumentacije za izdavanje dozvole za lek i za izdavanje trajne dozvole za lek. / Issues and challenges in submitting applications and formal assessment of documentation for the issuance of a license for a medicine and for the issuance of a permanent license for a medicine – Ljiljana Grujić, ALIMS
- Najčešća pitanja tokom procene dokumentacije o kvalitetu leka: Kako ih izbeći i efikasno rešiti. / Frequently asked questions during the evaluation of drug quality documentation: How to avoid them and solve them effectively – Stana Ubavić, ALIMS

Panelisti / Panelists:
Jadranka Mirković, ALIMS
Ivana Džunić, ALIMS
Ljiljana Grujić, ALIMS
Stana Ubavić, ALIMS
Bojan Trkulja, predstavnik udruženje INOVIA
Jelena Ognjenović, predstavnik udruženja GENEZIS
Slađana Gatić, predstavnik Udruženje za farmaciju i medicinsku delatnosti PKS

12:00-13:00

Pauza/Break

13:00-15:00

III sesija/session (samo na srpskom jeziku / only in Serbian language) – Predavanja i panel diskusija sa predstavnicima ALIMS i sva tri koorganizatora – drugi deo:
Dosadašnja iskustva, praktična pitanja, predlozi za unapređenje i komunikacije vezano za Pravilnik o sadržaju zahteva i dokumentacije, kao i načinu dobijanja dozvole za stavljanje leka u promet
/ Lectures and panel with representatives of ALIMS and all three co-organizers - first part: Previous experiences, practical issues, suggestions for improvement and communications relatedto the Rulebook on the content of applications and documentation, as well as the method of obtaining a marketing authorization

Moderatori:
Jadranka Mirković, ALIMS
Marko Erić, ALIMS

- Podnošenje pretkliničke i kliničke dokumentacije u postupcima izdavanja dozvole za lek, obnove dozvole za lek i izmene i dopune dozvole lek u zavisnosti od tipa zahteva. / Submission of pre-clinical and clinical documentation in the procedures for issuing a drug license, renewal of a drug license and amendments to the drug license depending on the type of application – Nikola Radosavljević, ALIMS
- Zahtevi farmakovigilance u postupcima izdavanja dozvole za lek, obnove dozvole za lek i izmene i dopune dozvole lek. / Pharmacovigilance requirements in drug authorization procedures, drug authorization renewals and drug authorization amendments. – Milena Cmiljanić, ALIMS

Panelisti / Panelists:
Jadranka Mirković, ALIMS
Marko Erić, ALIMS
Nikola Radosavljević, ALIMS
Milena Cmiljanić, ALIMS
Bojan Trkulja, predstavnik udruženje INOVIA
Jelena Ognjenović,  predstavnik udruženja GENEZIS
TBC, predstavnik Udruženje za farmaciju i medicinsku delatnosti PKS

ORGANIZATORI ZADRŽAVAJU PRAVO IZMENE PROGRAMA
THE ORGANIZERS RESERVE THE RIGHT TO CHANGE PROGRAM

Simpozijum se organizuje u skladu sa svim važećim merama i preporukama u pogledu zaštite zdravlja učesnika od zaraze SARS-CoV-2 virusom
The symposium is organized in accordance with all official measures and recommendations regarding the protection of the health of participants from SARS-CoV-2 virus infection.

Cena kotizacije

Kotizacija
Cena kotizacije uključuje pristup webinaru.

Cena kotizacije iznosi 18.000 RSD

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