Periodic Safety Update Report (PSUR)

09:00 – 13:00 COURSE SESSION

• European regulatory framework and guidelines
• PSUR submission timings and drugs exempted from PSUR submission: creation of the PSUR plan (Eurd List monitoring, consultation of other lists, …)
• PSUR format and document contents (including information to be requested from other departments). Key concepts will be described and which relevant information should be included and discussed in the document will be clarified
• Cross references with other documents and activities (RMP, signal analysis,…)
• Submission to PSUR repository (general description of steps)
• PSUSA procedure: what it is, which steps, examples of assessment reports and requests from the assessor, output of the procedure and regulatory consequences
• PSUSA Procedure FU

Personnel of pharmaceutical companies involved in the following departments:

> Pharmacovigilance
> Regulatory Affairs
> Medical-scientific

The course provides the theoretical foundations necessary to undertake the drafting of a PSUR and provides indications regarding the management and planning of the PSURs to be submitted.

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.