Pharmacovigilance peer-reviewed literature: strategies for an effective research and analysis

PROGRAM

09:30 – 12:30 COURSE SESSION

• EU regulatory references for screening of scientific medical literature in pharmacovigilance activities;
• Presentation of the various available literature sources (International databases, journals, …) and definition of selection criteria to identify relevant articles that contain valid and invalid ICSRs, and any other new safety and efficacy information on medicinal products;
• MedDRA Terminology;
• EMA’s Medical Literature Monitoring (MLM) service: what is the purpose and scope; tools available to the AIC holder;
• Some suggestions on how to integrate the description of the letter analysis screening process into corporate SOP/WIs;
• What to consider when delegating literature screening activities to a third party;
• Aspects to keep in mind when implementing local non-indexed literature screening;
• Characteristics of literature searches and integration of their analysis into documents such as Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR), Risk Management Plan (RMP), and signal analysis activities.

The course was designed for personnel involved in the following areas:

> Pharmacovigilance

> Regulatory Affairs

> Medical-scientific

The course provides the general theoretical basis for undertaking literature screening and analysis. However, the course is focused on activities of relevance to pharmacovigilance.

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.