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Learning outcomes

I farmaci sono elementi essenziali nel mantenimento dello stato di salute delle popolazioni e il loro beneficio è indubbio, tuttavia nessun farmaco è esente da rischi ed è quindi necessario continuare costantemente a sorvegliare i farmaci immessi sul mercato per meglio definire il loro profilo di tollerabilità. Queste attività vanno sotto il nome di farmacovigilanza e ormai da decenni sono regolate da norme e leggi europee e nazionali. La conoscenza di tutti i complessi aspetti della farmacovigilanza, da quelli scientifici a quelli normativi rappresenta uno dei contenuti generali del Master, così come la conoscenza della Farmacoepidemiologia e delle analisi statistiche principali ed avanzate per valutazioni postmarketing.
Il Master offre due distinti curriculum,
l'indirizzo "FV&DRFFARMACOVIGILANZA E DISCIPLINE REGOLATORIE DEL FARMACO" e
l'indirizzo "3F&RWDFARMACOEPIDEMIOLOGIA, FARMACOSORVEGLIANZA, FARMACOECONOMIA E ANALISI DI REAL WORLD DATA",
che presentano alcuni moduli e lezioni in comune, pur mantenendo gli obiettivi formativi specifici di seguito indicati. Per ciascun indirizzo
sono previsti un numero minimo di 10 e un numero massimo di 40 iscritti.

OBIETTIVI FORMATIVI SPECIFICI DELL’INDIRIZZO«FV&DRF-FARMACOVIGILANZA E DISCIPLINEREGOLATORIE DEL FARMACO»
Un contenuto specifico di questo percorso è la conoscenza delle attività regolatorie che regolano il mondo del farmaco, dalle procedure precedenti alla sua immissione in commercio a quelle successive, procedure complesse che impegnano Industria Farmaceutica e Autorità Regolatorie ad una continua attività. Infine un ulteriore contenuto specifico è rappresentato dalla conoscenza del vasto mondo dell'informazione sul farmaco e della comunicazione del rischio da farmaci.

OBIETTIVI FORMATIVI SPECIFICI DELL’INDIRIZZO «3F&RWD-FARMACOEPIDEMIOLOGIA, FARMACOSORVEGLIANZA, FARMACOECONOMIA E ANALISI DI REAL WORLD DATA» Acquisire un insieme di conoscenze teoriche, di strumenti metodologici e di esperienze pratiche in merito all’utilizzo di real world data
derivati da banche dati sanitarie o raccolta prospettica ad hoc per la conduzione di studi di farmacovigilanza, farmacoepidemiologia e farmacoeconomia che possano essere di interesse per le aziende sanitarie locali/Regioni per la pianificazione della spesa sanitaria, valutazione dell’effetto di interventi di politiche sanitarie relative all’uso dei farmaci, per aziende private ai fini di market access o monitoraggio postmarketing di farmacovigilanza e per centri accademici a fini di ricerca di natura clinico-assistenziale.

Professional profiles and employment and professional opportunities

Il Master offre due distinti percorsi formativi:
l'indirizzo "FV&DRF-FARMACOVIGILANZA E DISCIPLINE REGOLATORIE DEL FARMACO" e
l'indirizzo "3F&RWDFARMACOEPIDEMIOLOGIA, FARMACOSORVEGLIANZA, FARMACOECONOMIA E ANALISI DI REAL WORLD DATA".

PROFILO PROFESSIONALE E SBOCCHI OCCUPAZIONALI DELL’INDIRIZZO «FV&DRF FARMACOVIGILANZA E DISCIPLINE REGOLATORIE DEL FARMACO» Responsabile di farmacovigilanza nelle Industria Farmaceutica, nelle Azienda Sanitarie Locali, nelle Aziende Ospedaliere o negli Istituti di Ricovero e Cura a Carattere Scientifico; addetto alle attività regolatorie nell’ambito dell’Industria Farmaceutica; Agenzia Italiana del Farmaco; Agenzie regolatorie europee ed extra-europee; WHO Uppsala  Monitoring Centre; Consulente scientifico per giornali, riviste e altri media; Informatore scientifico del farmaco.


PROFILO PROFESSIONALE E SBOCCHI OCCUPAZIONALI DELL’INDIRIZZO «3F&RWDFARMACOEPIDEMIOLOGIA, FARMACOSORVEGLIANZA, FARMACOECONOMIA E ANALISI DI REAL WORLD DATA» Le professionalità formate all’interno del Master potrebbero trovare impiego in:
a) Aziende sanitarie pubbliche (es. servizi di farmaceutica, comitati etici, pianificazione sanitaria, controllo di gestione, osservatorio epidemiologico, commissioni farmaco e prontuari regionali a livello di Aziende Sanitarie Locali) od Assessorati Regionali della Salute od Agenzie Regionali della Sanità, laddove presenti);
b) Contract Research Organization (CRO) od altri enti di ricerca privati dediti alla conduzione di studi clinici osservazionali;
c) Aziende farmaceutiche con particolare riferimento alle attività di market access;
d) Università, presso gruppi di ricerca che sono attivi in ambito di farmacovigilanza, farmacoepidemiologia e farmacoeconomia.

Course poster

Locandina 2023

192 Kb 2022/2023

Altre informazioni

Indirizzi:
"FV&DRF-FARMACOVIGILANZA E DISCIPLINE REGOLATORIE DEL FARMACO"
"3F&RWD-FARMACOEPIDEMIOLOGIA, FARMACOSORVEGLIANZA, FARMACOECONOMIA E ANALISI DI REAL WORLD DATA"

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Spazio e-Learning del Modulo 3F&RWD: Farmacoepidemiologia, Farmacosorveglianza, Farmacoeconomia e Analisi di Real World Data (A.A. 2021/2022)
Spazio e-Learning del Modulo FVDRF: Farmacovigilanza e Discipline Regolatorie del Farmaco (A.A. 2021/2022)



The Italian University system

schema_qualita

First-cycle degrees: Bachelor’s degree programme

First-cycle degrees are aimed at enabling students to achieve a command of general scientific methods and content, and to acquire specific professional knowledge.
Admission requirements: secondary school diploma after completing 13 years of study in total and passing the relevant State examination, or equivalent foreign qualification; admission may be subject to further assessment.
Duration: three years.
Graduation: in order to obtain the degree, it is necessary to gain at least 180 CFU; doing an internship and preparing a dissertation/thesis may also be required. Upon completion of a Bachelor’s degree, graduates may continue their studies by enrolling in a Master’s degree or other second-cycle degree programmes and courses.
Academic title: upon completion of a Bachelor’s degree (Laurea), graduates are awarded the title of “Dottore”.

Second-cycle degrees: Master’s degree

Second-cycle degrees aim to provide students with an advanced training and knowledge to take on highly-skilled roles.
Admission requirements: applicants must hold a Bachelor’s degree, or a foreign equivalent qualification; curricular admission requirements for each course may vary depending on each University.
Duration: two years.
Graduation: in order to obtain the degree, it is necessary to gain at least 120 CFU, as well as preparing and presenting a dissertation/thesis.
Academic title: upon completion of a Master’s degree (Laurea Magistrale), graduates are awarded the title of “Dottore magistrale”. Single cycle/Combined Bachelor+Master’s degrees
Some courses (Medicine and Surgery, Veterinary Medicine, Dentistry and Dental Prosthetics, Pharmacy and Industrial Pharmacy, Architecture and Building Engineering-Architecture, Law, Primary Education) are offered as Single cycle/Combined Bachelor+Master’s degrees (Corsi di Laurea Magistrale a Ciclo Unico).
Admission requirements: applicants must hold a secondary school diploma or equivalent foreign qualification; admission is subject to passing an admission test.
Duration: five years (six years and 360 CFU for Medicine and Surgery, and Dentistry and Dental Prosthetics).
Graduation: in order to obtain the degree, it is necessary to gain at least 300 CFU, as well as preparing and presenting a dissertation/thesis. Upon completion of a Single-cycle degree, graduates may continue their studies by applying for a PhD programme (Dottorato di Ricerca) or other third-cycle courses.
Academic title: upon completion of a Master’s degree (Laurea Magistrale), graduates are awarded the title of “Dottore magistrale”.

Third-cycle degrees

PhD programmes: these courses enable students to gain reliable methodologies for advanced scientific research through innovative methodologies and new technologies, and generally include internships abroad and lab activities at research laboratories. Graduates wishing to apply for a PhD programme must have a Master’s degree (or a foreign equivalent qualification) and pass an open competition; PhD programmes have a minimum duration of three years. In order to complete the programme, students must produce a research thesis/dissertation and present it at a final examination.
Academic title: upon completion of a PhD programme, students are awarded the title of “Dottore di ricerca”, or “PhD”.
Postgraduate specialisation courses: these are third-cycle courses aimed at enabling students to develop advanced knowledge and highly-specialised skills, such as in the medical, clinical and surgical fields. To be admitted to these courses, applicants must have a Master’s degree (or a foreign equivalent qualification) and pass an open competition. Postgraduate specialisation courses may last from two (120 CFU) to 6 years (360 CFU) depending on the type. Academic title: upon completion of this programme, graduates are awarded a “Diploma di Specializzazione”.

Professional Master’s programme

1st-level Professional Master’s programmes: these courses enable students to further enhance their scientific knowledge and professional skills. In order to apply, applicants must have a Bachelor’s degree, or foreign equivalent qualification. The minimum duration is one year (60 CFU). Please note that completing this course will not provide you with direct access to a PhD programme (Dottorato di Ricerca), or other third-cycle courses, as these courses are run and managed by each University at the local level. Upon completion of this programme, students are awarded a “Master universitario di primo livello”.
2nd-level Professional Master’s programmes: these courses enable students to further enhance their scientific knowledge and professional skills. In order to apply, applicants must have a Master’s degree, or foreign equivalent qualification. The minimum duration is one year (60 CFU). Please note that completing this course will not provide you with direct access to a PhD programme (Dottorato di Ricerca), or other third-cycle courses, as these courses are run and managed by each University at the local level. Upon completion of this programme, students are awarded a “Master universitario di secondo livello”.

Other useful things

Crediti Formativi Universitari (CFU/ECTS credits): Italian university courses are based on the CFU system. 1 CFU is equal to 25 hours of study. The average annual academic workload for a full-time student is generally assumed to be 60 CFU. CFU and ECTS credits serve the same purpose and generally have the same value.
Degree class: Bachelor's and Master's degree programmes that have the same learning objectives and activities are grouped into “degree classes". The educational content of each programme is set autonomously by each university; however, universities are required to include certain educational activities (and the corresponding number of CFU credits) set at the national level. These requirements are established in relation to each degree class. Degrees in the same class have the same legal value.
Double/Joint degrees: the Italian universities may establish degree programmes in partnership with other Italian or foreign universities. Upon completion of these courses, graduates are awarded a joint or double/multiple degree, one from each Partner University.

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