Select Page
Event info
Date:24 Sep
Time:2 days
Venue:Barcelona, Spain

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: 24-25 September 2019
Time: 09:00 am – 6:00 pm
Venue: Barcelona, Spain
Cost: Early bird: € 1670* (until 27-08-2019)
            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

READ MORE & SIGN UP

Registration offline
Fill in the registration form (last page of the event brochure) and email it to maraclaudia.algarotti@lsacademy.com and she will process the booking at a 15% discount.

Registration online
Complete booking and payment at this link and use code MVA1908 to book and receive 15% off.

CONTACT
For any further question feel free to contact Mara Claudia Algarotti maraclaudia.algarotti@lsacademy.com