Training Course on Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing Course

Date(s) And Time(s):
May 16 2011 7:00AM - May 18 2011 3:00PM

Novotel Nice France Acropolis
8/10 Parvis de l'Europe
06300 Nice

This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post marketing studies, and in the healthcare setting following product launch.

Key Topics

Legal basis for safety reporting including a historical perspective
Basic definitions and tools
Data collection and processing in post-marketing phase
Medical evaluation
Safety reporting requirements in pre-marketing phase
A workshop and practical exercises
Safety reporting requirements in the post-marketing phase
An introduction to risk communication
Inspections in pharmacovigilance
Introduction to risk management, epidemiological methods for signal detection and risk assessment

Target Audience:

Beginner Level

Individuals with limited experience in the clinical safety/pharmacovigilance area. Those from the pharmaceutical industry, academia, regulatory authorities. Medical writers, marketing personnel, and those who need an overview of clinical safety and may interact with members of those departments.

Event Code:

Contact Information:
DIA Europe
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52