PHARMACOVIGILANCE DOCUMENTS IN THE LIFE CYCLE OF A MEDICINAL PRODUCT: DSUR, RMP, PSUR/PBRER, AND ADDENDUM TO THE CLINICAL OVERVIEW
From patients to health authorities: data collection, signal management, document preparation, authority assessment
This course gives an overview of the pharmacovigilance activities and the related documents throughout the life cycle of a medicinal product. After an introduction on benefit-risk analysis, signal management, and data collection process, the presentations will focus on regulatory, format and content requirements of the main pharmacovigilance documents. While the course is based on the EU requirements, a few relevant insights about the most relevant local requirements will be provided. The participants will learn how to plan and manage documents in the life cycle and how to address selected challenges of document preparation.
Date: 21-22 May 2019
Time: 9:00 am – 6:00 pm
Venue: Rome, Italy
Cost: Early bird: € 1670* (until 30-04-2019)
Ordinary: € 1880*
Freelance – Academy – Public Administration: € 890*
* For Italian companies: + 22% VAT
The fee includes: tuition, teaching materials, lunches and coffee breaks, office assistance, attendance certificate
Complete booking and payment at this link and use code MVA1908 to book and receive 15% off.
For any further question feel free to contact Mara Claudia Algarotti firstname.lastname@example.org