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

  • 2° EDITION: 11 April 2024
  • Online
  • Italian

Training overview

The pharmacovigilance system has evolved over time, starting from the benefit/risk assessment of a drug performed on the analysis of individual cases arriving at the development of periodic safety reports and finally finding its full expression in Good Pharmacovigilance Practices (GVPs). The application of the principles of GVPs, with the management of risk and quality plans, has made pharmacovigilance a major function in the Pharmaceutical Company today. With a view to continuous improvement of the appropriateness of use of a given pharmaceutical treatment towards the patient, the Pharmacovigilance specialist must play this delicate role to the best of his or her ability and must develop an all-round technical and practical expertise on GVPs. Moreover, the digital transformation typical of the modern era is radically changing both the business approach of pharmacovigilance practitioners and the characteristics of the pharmacovigilance professional figure that will be sought after in the near future.

ARE YOU INTERESTED IN PHARMACOVIGILANCE TRAININGS?

Sign up for 3 courses and you’ll get a 15% discount*, while if you choose 5 courses you’ll get a 20% discount*. You may choose from these trainings:

(*) discounts apply to full prices and cannot be combined with other promotions. The promotion is valid for the enrollment of the same attendee in 3 or 5 courses among those proposed.

Key points of the training

  • Better manage adverse event reporting requirements in accordance with GVPs and Eudravigliance
  • Better manage interactions with other departments and Third Parties
  • Better manage the local pharmacovigilance system, to the parent system and to local and European Regulatory Agencies
  • Better manage the quality system
  • Explore new opportunities in pharmacovigilance as a result of digital transformation

09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION

MORNING SESSION

  • 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

AFTERNOON SESSION

  • 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 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.

Speakers

Grazia Sirizzotti

Grazia Sirizzotti

Senior Drug Safety Manager

Graduated in Biological Sciences in 2001 at the University of Milan, she worked for about three years at the National Cancer Institute of Milan. She began her career within the pharmaceutical industry in the Medical Department of Novartis Italia S.p.a with the role of Senior Clinical Safety Associate. Subsequently she continued her career in Recordati S.p.a. where she holds the role of Deputy of the QPPV in a Mother House. From 2009 to 2015 she was Pharmacovigilance Manager of the Italian subsidiary of Grunenthal Italia S.p.a. Since 2015 she has held the role of Local Pharmacovigilance Contact in Biogen Italia S.r.l..

Register now

Early Bird 10%
Within 2 months before the start of the training
720€
800€
Early Bird 5%
Within 1 month before the start of the training
760€
800€
Full price

800€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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