{"id":10051,"global_id":"jurmed.ro\/medici?id=10051","global_id_lineage":["jurmed.ro\/medici?id=10051"],"author":"9","status":"publish","date":"2020-02-19 11:37:50","date_utc":"2020-02-19 11:37:50","modified":"2020-02-19 11:37:50","modified_utc":"2020-02-19 11:37:50","url":"https:\/\/jurmed.ro\/medici\/eveniment\/curs-monitori-studii-clinice-pentru-incepatori-27-28-februarie-bucuresti\/","rest_url":"https:\/\/jurmed.ro\/medici\/wp-json\/tribe\/events\/v1\/events\/10051","title":"Curs Monitori Studii Clinice pentru \u00cencep\u0103tori, 27-28 Februarie, Bucure\u0219ti","description":"

\"\"<\/a>Cursul de monitori \u00eencep\u0103tori organizat de Avantyo Institute of Clinical Research, reprezint\u0103 o oportunitate pentru cei care vor s\u0103 se instruiasc\u0103 \u00een activit\u0103\u021bi de studiile clinice. Evenimentul se va desf\u0103\u0219ura la Park Inn by Radisson Blu Bucharest Hotel – Sala Jupiter, pe 27-28 Februarie 2020.<\/p>\n

Trainingul va fi \u021binut de Dr. C\u0103t\u0103lina S\u00e2rbu, Pre\u0219edintele ACCSCR (Asocia\u021bia Companiilor Conduc\u0103toare de Studii Clinice din Rom\u00e2nia) \u00een limba englez\u0103.<\/p>\n

Vizita\u021bi pagina evenimentului pentru inscriere online \u0219i detalii \u00een timp real despre num\u0103rul de locuri disponibile, adres\u0103, agend\u0103, certificate de participare –\u00a0 https:\/\/www.avantyo.com\/training\/cra-training-program\/cra-entry-level<\/a>.<\/p>\n

AVANTYO \u00ee\u0219i deschide seria de cursuri din 2020 cu programul de instruire dedicat monitorilor, celor afla\u021bi \u00een centrul proiectelor de studii clinice, etap\u0103 important\u0103 \u00een lungul drum al transform\u0103rii moleculei descoperite \u00een laborator \u00een tratament pentru pacien\u021bi.<\/p>\n

CRA sunt cei care monitorizeaz\u0103 respectarea protocoalelor \u0219i reglement\u0103rilor studiilor clinice, fiind \u00een acela\u0219i timp \u0219i leg\u0103tura dintre sponsorul farma, echipa de medici investigatori \u0219i al\u021bi furnizori. Ei pot lucra direct cu compania sponsor (farma) ca freelanceri independen\u021bi sau pentru\u00a0 o companie conduc\u0103toare de studii clinice (CRO).<\/p>\n

De obicei, un CRA trebuie s\u0103 de\u021bin\u0103 o diplom\u0103 academic\u0103 \u00een \u0218tiin\u021bele Vie\u021bii (biomedicale) \u0219i obligatoriu s\u0103 cunoasc\u0103 bunele practici clinice \u0219i reglement\u0103rile. In \u021b\u0103rile occidentale, exist\u0103 module de formare universitare \u0219i post universitare pentru CRA. \u00cen Rom\u00e2nia, monitorii trebuie s\u0103 participe periodic la traininguri pentru a fi mereu la curent cu ultimele nout\u0103\u021bi.<\/p>\n

AVANTYO Institute of Clinical Research ofer\u0103 celor interesa\u021bi un program de instruire pentru Monitori Studii Clinice \/ Clinical Research Associates (CRA) care este structurat \u00een doua module, pentru \u00eencep\u0103tori \u0219i avansa\u021bi.<\/p>\n

Cursul din februarie 2020 este pentru \u00eencep\u0103tori, fiind destinat instruirii proaspe\u021bilor profesioni\u0219ti din studii clinice care vor s\u0103 \u00ee\u0219i \u00eembun\u0103t\u0103\u021beasc\u0103 cuno\u0219tin\u021bele (monitorii juniori \/ Junior CRA), celor ce lucreaz\u0103 \u00eentr-un CRO dar vizeaz\u0103 o alt\u0103 pozi\u021bie (asisten\u021bi de cercetare clinic\u0103 \/ CTA, speciali\u0219ti \u00een reglementare etc), sau medicilor, farmaci\u0219tilor, reziden\u021bilor, biologilor \u0219i biochimi\u0219tilor care doresc s\u0103 intre acum \u00een domeniul fascinant al studiilor clinice ca monitori.<\/p>\n

Pe l\u00e2ng\u0103 concepte teoretice \u0219i reglement\u0103ri, Dr. S\u00e2rbu va prezenta la curs \u0219i exemple din situa\u021bii reale. Valoarea unui curs face-to- face cu trainerul r\u0103m\u00e2ne incontestabil\u0103, d\u00e2nd posibilitatea de a interac\u021biona mult mai bine, de a pune \u00eentreb\u0103ri \u0219i de a l\u0103muri subiectele neclare.<\/p>\n

Curricula cuprinde subiecte despre evolu\u021bia \u0219i etapele studiilor clinice, modul \u00een care se desf\u0103\u0219oar\u0103 acestea,\u00a0 reglement\u0103rile care se aplic\u0103, responsabilit\u0103\u021bile actorilor principali (echipa de medici investigatori, monitorii si sponsorii farma) \u0219i documentele esen\u021biale ale studiului, dosarul pacientului,\u00a0 investiga\u021biile non-clinice \u0219i punerea \u00een practic\u0103 a principiilor\u00a0 ALCOAC (Attributable, Legible, Contemporaneous, Original, Accurate).<\/p>\n

Un rol important \u00een structura cursului \u00eel ocup\u0103 Consim\u021b\u0103m\u00e2ntul Informat<\/em> \u0219i reglement\u0103rile legale privind pacien\u021bii, procedurile \u0219i raportarea \u00een siguran\u021b\u0103 \u00eentre actorii studiului, preg\u0103tirea pentru audituri \u0219i inspec\u021bii ale sponsorilor \u0219i ale autorit\u0103\u021bilor de reglementare.<\/p>\n

Managementul datelor, analizele statistice, felul \u00een care se face arhivarea la centrul medical de recrutare a pacien\u021bilor sau la sponsor, contractele cu diferi\u021bi membrii ai echipei \u0219i subcontractarea furnizorilor, sunt si ele prezentate la curs.<\/p>\n

Despre AVANTYO Institute of Clinical Research<\/em><\/strong><\/p>\n

AVANTYO Institute of Clinical Research este o companie rom\u00e2neasc\u0103 de training, formare medical\u0103 \u0219i consultan\u021b\u0103 care ofer\u0103 o platform\u0103 de networking at\u00e2t pentru profesioni\u0219tii cu experienta c\u00e2t \u0219i pentru cei afla\u021bi la \u00eenceput de drum, astfel \u00eenc\u00e2t ace\u0219tia s\u0103 se interconecteze, s\u0103 \u00eenve\u021be, s\u0103 progreseze \u00een cercetare \u0219i s\u0103 se dezvolte pentru a putea atinge succesul \u00een domeniul cercet\u0103rii clinice. Prin facilitarea re\u021belelor \u0219i a colabor\u0103rii \u00eentre to\u021bi actorii implica\u021bi \u00een procesul de cercetare clinic\u0103, AVANTYO \u00eembun\u0103t\u0103\u021be\u0219te accesul pacientului la medica\u021bie inovativ\u0103. <\/em>www.avantyo.com<\/em><\/a><\/p>\n

AVANTYO Institute of Clinical Research este organizatorul simpozionului na\u021bional de studii clinice cu participare interna\u021bional\u0103 \u201eClinical Trials Symposium\u201d. 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