The Pharmacovigilance system and its local applications according to legislation and Eudravigilance

09:30 – 13:00 DAY 1
09:30 – 13:00 DAY 2

SESSION DAY 1

• Pharmacovigilance: overview, historical background, evolution and objectives
• Pharmacovigilance legislation in Europe and Italy
• Role of national and international regulatory agencies (AIFA, EMA)
• Role of the AIC Holder
• Interactions of pharmacovigilance with other business functions
• Pharmacovigilance interactions with third parties
• Pharmacovigilance in clinical research: interventional, observational, nonprofit studies
• Post-marketing pharmacovigilance: sources and individual case management
• Module VI: the management of spontaneous/solicited reports
• Pharmacovigilance management in market research, PSP, digital media
• Management of si special reports: compassionate use, Act 648, off-label
• Eudravigilance

SESSION DAY 2

• New standards in Pharmacovigilance: the quality system
• Quality Management System in individual PV processes (Audits, Inspections, SOPs, documentation management, Training)
• Hints on pharmacovigilance and privacy
• Digital transformation and impacts on pharmacovigilance

Specialists who work or who are interested in working in Italian pharmaceutical companies in the field of pharmacovigilance (affiliate or parent company), who want to deepen the issues of quality and good practice of pharmacovigilance, with an eye to the future linked to digital transformation.

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.

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 in**@*******************er.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 in**@*******************er.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.