Pharmacovigilance in Clinical Trials

  • 2° EDITION: 20 March 2024
  • Online
  • Italian

Training overview

One of the main priorities of a clinical trial is the safety of the subjects enrolled in it. For this reason, pharmacovigilance in clinical trials is one of the most important aspects to consider for proper risk assessment of the experimental drug. Therefore, it should always be evolving and adapted to regional and local regulations. The introduction of Regulation (EU) No. 536/2014 of the European Parliament is a new challenge to be faced but at the same time an opportunity for an area, such as Europe, hitherto fragmented by various local regulations. For the purpose of assessing the benefit-risk ratio, the Development Safety Update Report (DSUR) is a mandatory annual report to be submitted to the Competent Authority and aimed at informing about the progress of the clinical trial and the safety risk analysis of the investigational drug under study, comparing also with worldwide experience, so as to ensure proper protection for enrolled subjects.

Key points of the training

  • Reference legislation for pharmacovigilance in clinical trials
  • Which figures are involved and their responsibilities
  • Proper management of pharmacovigilance in clinical trials
  • How to establish a proper relationship between Sponsors and CROs and what information is necessary for pharmacovigilance for drafting the documents
  • What is the format of the DSUR and what information needs to be presented and analysed

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

  • Normative requirements
  • Types of clinical trials
  • Figures involved and responsibilities
  • Management of reports from clinical trials
  • Safety Management Plan
  • Development Safety Update Report

Personnel involved in the areas of Pharmacovigilance, Clinical, Regulatory Affairs. The course provides the theoretical basis necessary for the correct management of pharmacovigilance in clinical trials and provides indications regarding the management and planning of the DSUR 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.

Speakers

Luca Rindi

Luca Rindi

Senior Drug Safety Officer at Pharma D&S

Graduated in Pharmacy from the University of Florence with a thesis on pharmacovigilance, after a first experience in pharmacy in contact with patients, he has been working in Pharma D&S since 2019 as Senior Drug Safety Officer. He currently holds the position of QPPV/Deputy for MA holders based in the European Community, for which he contributes to the maintenance of the pharmacovigilance system. He has gained experience in the management of clinical trials dealing with pharmacovigilance management, the drafting of Safety Management Plan, Development Safety Update Report (DSUR) and SUSAR submission, as well as gained experience in post-marketing pharmacovigilance management.

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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