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UNIVERSITATIS DISPUTATIONE 2012: Bolo by možné liečiť bez liekov? (1.diskusia)


 | 22.10.2012 | komentárov: 300

Dňa 23. októbra 2012 sa v priestoroch historickej auly rektorátu uskutoční prvá z cyklu diskusií UNIVERSITAS DISPUTATIONE 2012, tentokrát na tému "Bolo by možné liečiť bez liekov?". Diskusie sa zúčastní viacero rôznorodých odborníkov, ktorí s touto problematikou prichádzajú do praktického kontaktu a disponujú množstvom skúseností.

Obrazok Konkrétne sa zúčastní bioetik, zástupca Štátneho ústavu pre kontrolu liečiv, právnik veľkého poskytovateľa zdravotnej starostlivosti, výkonný riaditeľ v Slovenskej asociácii farmaceutických spoločností orientovaných na výskum a vývoj a odborník pôsobiaci vo farmaceutickej spoločnosti.

Miesto: Historická aula rektorátu UPJŠ, Šrobárova 2, Košice

Termín: 23. októbra 2012

Čas: 15.30

Základné tézy diskusie: Povieme si kedy sa lieči liekmi a ako liek vzniká, rozoberieme právny a etický pohľad na klinické skúšanie liekov a pokúsime sa odpovedať na otázky ako je chránený účastník výskumu a aká je komunikácia medzi zadávateľom výskumu a pracoviskom. A vlastne, je spravodlivé žiadať náhradu všetkých nákladov liečby pri účastníkovi výskumu?




Profily diskutujúcich:




doc. ThDr. Ing. Inocent-Mária V. Szaniszló, Ph.D.



V roku 2005 ukončil štúdium piatimi štátnymi skúškami a doktorskou prácou a získal titulu Doktora teológie so známkou "Summa Magna cum laude" (promovaný 8.7.2005 vo Freiburgu). Pracuje v oblasti všeobecnej a špeciálnej teologickej etiky ako aj politickej filozofie a za jeho vedecké výsledky bol menovaný Najlepším odborným asistentom teologickej fakulty v Košiciach v roku 2008, a najlepším docentom v roku 2009 a 2010. Od novembra 2008 je habilitovaným docentom na Teologickej fakulte Katolíckej univerzity Ružomberok, kde sa habilitoval s prednáškou: Riešenie konfliktu magistéria a teológa a publikáciou: Úvod do špeciálnej morálnej teológie podľa Božích prikázaní- Božské čnosti.  Pracuje s Prof. Matthiasom Vogtom z Vyšokej školy Zittau-Goerlitz na projekte Kultúrneho manažmentu Cirkví a takisto v dvoch sieťach CEEPUSu: bioetická sieť ACEBE Prof. Sigrid Muellerovej (asociácie bioetikov strednej a východnej Európy so sídlom vo Viedni pri Inštitúte systematickej teológie Univerzity Viedeň) ako aj sociálno-etická sieť Prof. Ingebor Gabriel pri tej istej Univerzite. Zároveň už 3 roky prednáša bioetiku Na odbornom kolégiu sv. Pavla pri Pedagogickej fakulte Benedeka Eleka Západomaďarskej Univerzity v Šoproni (aj v programe Erazmus) a pracuje s kolegom prof. W. Schauppom v rakúskom Grazi, pri formáciu doktorandov v oblasti morálnej teológie.

doc. Szaniszló sa pokúsi okrem iného zodpovedať aj tieto otázky: či je skúšanie nových vecí s neistým výsledkom etické, či existuje „morálna povinnosť“ zúčastniť sa výskumu a ako by malo vyzerať etické zapojenie pacienta do klinického skúšania, resp. aké sú hlavné etické/morálne dilemy spojené s skúšaním liekov/výskumom?




Ing. Bc. Štefan Mesároš, PhD.


Ing. Bc. Štefan Mesároš, PhD., ktorý je od roku 1998 činný vo farmaceutickom priemysle. Je absolventom Slovenskej technickej univerzity (odbor analytická chémia), kde neskôr pôsobil ako odborný asistent a získal titul PhD.. V polovici 90-tych rokov minulého storočia pracoval ako Research Associate na Oakland University (Michigan, USA) v oblasti výskumu „Nitric Oxide“. V súčasnosti pôsobí vo funkcii výkonného riaditeľa v Slovenskej asociácii farmaceutických spoločností orientovaných na výskum a vývoj (SAFS) a v roku 2012 získal titul Bc. v odbore právo na Právnickej fakulte Paneurópskej vysokej školy v Bratislave.Disponuje aj rozsiahlou publikačnou činnosťou a vystúpeniami na významných vedeckých podujatiach a mesiaci september 2012 bol hosťom mesiaca portálu www.pravo-medicina.sk.

Ing. Mesároš sa bude v rámci diskusie venovať okrem iného aj týmto bodom: Sú lieky potrebné, resp. nie je ich množstvo (druhy) len výrazom snahy zvýšiť ekonomický zisk výrobcov bez ohľadu na to, či sú naozaj potrebné? Aké sú príklady výrazného pozitívneho vplyvu použitia lieku na zvládnutie choroby/e? Je súčasná legislatíva prajná pre vývoj a registráciu liekov na Slovensku – resp. je prajná pre prinášanie nových liekov pacientom?




MUDr. Igor Novák, MPH


MUDr. Igor Novák, MPH.  vyštudoval lekársku fakultu UK v Bratislave. Promoval v roku 1990, potom pracoval 10 rokov ako detský anestéziológ a lekár na jednotke intenzívnej starostlivosti pre deti. Od roku 1999 pracuje vo farmaceutických spoločnostiach. Najprv pracoval na medicínskom oddelení, najskôr ako monitor klinických štúdií, následne ako riaditeľ medicínskeho oddelenia.

Od roku 2009 ja zamestnaný v  spoločnosti Novartis, kde  pracuje ako vedúci oddelenia pre vonkajšie vzťahy a má na starosti aj cenotvorbu a je zodpovedný za vstup liekov spoločnosti na trh. Popri tom od roku 2009 je aj prezidentom Asociácie dodávateľov liekov a zdravotníckych pomôcok. Táto asociácia združujúca celý liekový reťazec (výrobcov, distribútorov, lekárnikov) existuje už 20 rokov a jej hlavným cieľom je transparentný a predvídateľný zdravotný systém s dôrazom na liekovú politiku. ADL chce byť dôveryhodným partnerom ministerstva zdravotníctva pri tvorbe zdravotníckej legislatívy. V súčasnosti je hlavnou úlohou ADL napomôcť zmenám v liekovej politike v prospech slovenského pacienta, tak aby sa na Slovensko dostávali lieky včas a aby bol adekvátne ohodnotený ich prínos, čo umožní aby boli aj cenovo dostupné.

MUDr. Novák vo svojom príspevku rozoberie nasledujúce témy: Ako dlho trvá vývoj lieku a je tento vývoj nákladným procesom?  Ako vyzerá skúšanie lieku v rámci celého reťazca (cesta z laboratória až k pacientovi)? Neohrozuje zaradenie pacienta do skúšania jeho zdravie a nie je v dôsledku zaradenia prerušená jeho štandardná liečba?




MUDr. Pavol Gibala, CSc.


MUDr. Pavol Gibala, CSc. je absolventom Lekárskej fakulty Univerzity Komenského v Bratislave. Štúdium ukončil v roku 1975. Po skončení štúdia na vysokej škole pokračoval v štúdiu na Farmakologickom ústave SAV, kde ďalej pôsobil vo funkcii samostatného vedeckého pracovníka  v oblasti kardiovaskulárnej experimentálnej farmakológie.  Od roku 1990 pracuje v Štátnom ústave pre kontrolu liečiv vo funkcii vedúceho sekcie a zástupcu riaditeľa. Zaoberá sa farmakovigilanciou a klinickým skúšaním liekov.

MUDr. Gibala sa pokúsi o.i. odpovedať aj na tieto otázky: Akú úlohu má ŠÚKL v procese skúšania humánnych liekov? Interesuje sa do skúšania liekov aj EÚ a aký je zmysel masívnej harmonizácie práva v oblasti skúšania liekov? Má zmysel skúšanie liekov na Slovensku a pre pacienta bezpečné? Má ŠÚKL dostatočné kapacity na to, aby zabezpečil svoje úlohy ktoré mu zo zákona vyplývajú?





JUDr. Dušan Podolský


Ukončil Právnickú fakultu Univerzity P.J. Šafárika v roku 1998. V roku 2000 absolvoval rigoróznu skúšku v študijnom odbore právo. V roku 2003 bol zapísaný v zozname advokátov Slovenskej advokátskej komory a v roku 2004 získal odbornú spôsobilosť - Ohodnocovanie majetku podnikov. V rokoch 1998-1999 pracoval ako samostatný odborný radca na Exekútorskom úrade v Košiciach, v rokoch 1999-2002 ako právnik Ústredného daňového riaditeľstva SR, pracovisko Košice. Od júna 2002 pracuje v spoločnosti Nemocnica Košice-Šaca ako právnik a vedúci Odboru právneho, personalista a člen vedenia spoločnosti Nemocnica Košice-Šaca a.s.1. súkromná nemocnica


JUDr. Podolský sa pokúsi o.i. zodpovedať aj na tieto otázky: Akú úlohu zohrávajú nemocnice v procese skúšania liekov? Aké práva majú mať pacienti zaradení do skúšania zabezpečené, a ktoré sú primárne riziká skúšania pre poskytovateľa zdravotnej starostlivosti? Má mať zadávateľ prístup k osobným údajom pacientov? Je skúšanie liekov prospešné pre nemocnicu a je prospešné pre pacientov?





JUDr. Ivan Humeník, Ph.D.

JUDr. Ivan Humeník, Ph.D. sa narodil v Košiciach. Právnickú fakultu vyštudoval v Trnave (2003).  V roku 2006 získal na Právnickej fakulte Trnavskej univerzity v Trnave titul JUDr. V roku 2011, pod vedením prof. JUDr. Petra Vojčíka, CSc., obhájil na Právnickej fakulte UPJŠ v Košiciach dizertačnú prácu týkajúcu sa ochrany osobnostných práv pri poskytovaní zdravotnej starostlivosti a bol mu udelený titul Ph.D. Počnúc diplomovou prácou sa orientuje na problematiku medicínskeho práva. Je partnerom v advokátskej kancelária h&h PARTNERS, v ktorej od roku 2008 vykonáva advokátska prax. Okrem advokátskej praxe sa venuje aj akademickej činnosti na Právnickej fakulte UPJŠ v Košiciach, kde vedie predmet Medicínske právo. Je odborným garantom internetového projektu www.pravo-medicina.sk.


JUDr. Humeník bude diskusiu moderovať.



VIAC SA O PROJEKTE UNIVERSITATIS DISPUTATIONE 2O12 DOZVIETE NA medius.sk TU.




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