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Cristina Collalti

Saúde e medicina

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Le novità legislative sulla Farmacovigilanza introdotte dal Regolamento N.1235/2010 e dalla Direttiva 2010/84/EU nel dicembre 2010, rappresentano, all’interno dell’Unione Europea, il cambiamento più significativo dal 1995 sulla legislazione del medicinale per uso umano. L’EMA, alla guida di tale importante cambiamento, sta sviluppando sistemi e linee guida per supportare tutti gli stakeholders di tale nuovo processo effettivo dal Luglio 2012. Ad oggi è diventata affettiva la maggior parte dei moduli sulle Good Pharmacovigilance Practices, i cui contenuti rappresentano la via per soddisfare i requisiti della nuova legislazione. Durante il corso verranno analizzati gli aspetti base del Sistema di Farmacovigilanza alla luce delle ultime novità legislative e verranno forniti esempi pratici a supporto.

Come implementare un efficace Pharmacovigilance Quality System

Cristina Collalti

Negli ultimi anni, il Servizio Sanitario Nazionale si è sempre più focalizzato sui temi del controllo della spesa sanitaria, e, conseguentemente, l’azienda farmaceutica, in funzione della sostenibilità del SSN, si trova a dover affrontare, da un lato il contenimento dei prezzi e dall’altro, a dover dimostrare un indice favorevole del benificio/rischio e dell’innovatività terapeutica. In questo scenario assumono particolare importanza le competenze del Market Access. Nel corso della giornata i docenti approfondiranno le tematiche relative a: procedure di prezzi e rimborsi, i criteri alla base della negoziazione, la formulazione del dossier prezzi, le leve di valorizzazione del prodotto, l’accesso del farmaco nel mercato, l’approccio health technology assessment (HTA) e la negoziazione con AIFA.

Il Market Access del farmaco: quali strategie nel nuovo paradigma? - Milano 1...

Cristina Collalti

A seguito della recente pubblicazione delle nuove Linee Guida Europee sulle Norme di Buona Distribuzione (GDP) del 5 Novembre 2014 e dei recenti sviluppi Normativi in Italia (Decreto Legislativo17 del19 Febbraio 2014), al fine di assicurare che la qualità e la sicurezza del prodotto farmaceutico sia garantita e mantenuta inalterata durante tutta la catena distributiva (dal sito produttivo fino alla consegna al Cliente finale), diventa essenziale e di fondamentale importanza per le Case Farmaceutiche effettuare la qualifica del fornitore di servizio dell’attività di stoccaggio e distribuzione. Il Seminario in oggetto è stato progettato per fornire alle Case Farmaceutiche, i punti fondamen tali da verificare durante un’ispezione ad un distributore di farmaci, mentre a chi viene ispezionato (coloro che appartengono al settore del trasporto e della distribuzione) le indicazioni necessarie per prepararsi a ricevere e superare con successo un’ispezione da parte del Committente. Inoltre il Seminario fornirà un quadro dettagliato sull’evoluzione delle GDP a livello Europeo e la loro l’applicabilità all’attuale filiera del farmaco in Italia (risvolti sulle attività operative ed organizzative dei players logistici, compreso il depositario ed il grossista).

Ispezioni ai Distributori di Farmaci - Milano, 11 Dicembre 2014

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Giornata di Analitica Farmaceutica - Milano 3 Dicembre 2014

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Metodologie statistiche applicate alla chimica analitica

Cristina Collalti

Partecipa alla terza edizione del Clinical Research Forum! Il tema di quest'anno sono le nuove sfide per la Ricerca Clinica, tema attualissimo che apre al confronto e alla discussione su come ridurre costi e tempi della sperimentazione clinica. Al convegno parteciperanno le dottoresse Angela Del Vecchio e Donatella Gramaglia, funzionarie dell'AIFA e professionisti di consolidata esperienza nel settore provenienti da aziende farmaceutiche, comitati etici e CRO. Per maggiori informazioni sul programma e sui relatori visita il sito http://www.clinicalresearchforum.it/

Le nuove sfide per la Ricerca Clinica - Milano 12 novembre 2014

Cristina Collalti

Regulatory Affairs Forum 2014 - 16 Ottobre 2014 Milano - Istituto Pirelli

Cristina Collalti

Il prossimo appuntamento con i grandi eventi di Pec è il 16 ottobre 2014 a Milano con il Regulatory Affairs Forum. Al centro della giornata ci saranno l'attualissimo tema del Redability Test e le variazioni regolatorie. Tra i relatori della giornata la Dr.ssa Roberta Ranalli dell'Uffico Valutazione e autorizzazione AIFA e affermati professionisti del settore. Visitate il sito dell'evento! www.regulatoryaffairsforum.it

Regulatory affairs forum

Cristina Collalti

Pharma Education Center

Cristina Collalti

Il Clinical Education Program è il percorso formativo che PEC, Pharma Education Center, ha progettato per gli operatori del settore studi clinici. E' un percorso formativo modulabile adatto sia a chi vuole affacciarsi al settore della ricerca clinica che a quanti vogliono aggiornarsi e acquisire nuove conoscenze. I moduli sono allineati ai requisiti previsti dal decreto ministeriale del 15 novembre 2011 Deﬁnizione dei requisiti minimi per le organizzazioni di ricerca a contratto (CRO) nell’ambito delle sperimentazioni cliniche di medicinali.

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Pharma Education Center

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