Il sistema di Farmacovigilanza e le sue applicazioni locali secondo la normativa ed Eudravigilance

Struttura del corso

09:30 – 12:30 PRIMO GIORNO
09:30 – 12:30 SECONDO GIORNO

Programma

PROGRAMMA GIORNO 1

• La farmacovigilanza: quadro generale, cenni storici, evoluzione ed obiettivi
• La legislazione sulla farmacovigilanza in Europa e in Italia
• Ruolo delle agenzie regolatorie nazionali ed internazionali (AIFA, EMA)
• Ruolo del Titolare AIC
• Interazione della farmacovigilanza con le altre funzioni aziendali
• Interazioni della farmacovigilanza con le parti terze
• La farmacovigilanza nella ricerca clinica: studi interventistici, osservazionali, no profit
• La farmacovigilanza post-marketing: fonti e gestione dei singoli casi
• Il modulo VI: la gestione delle segnalazioni spontanee/solicited
• Gestione della farmacovigilanza nelle ricerche di mercato, PSP, digital media
• La gestione delle segnalazioni si speciali: uso compassionevole, legge 648, off-label
• Eudravigilance

PROGRAMMA GIORNO 2

• Nuovi standard di Farmacovigilanza: il sistema di qualità
• Quality Management System nei singoli processi di FV (Audit, Ispezioni, SOP, gestione della documentazione, Training)
• Accenni su farmacovigilanza e privacy
• La trasformazione digitale e gli impatti sulla farmacovigilanza

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

Attendance to the event will be allowed upon receipt of payment.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.