概览

This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements. This five-day training course also includes highlights and updates on the pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.

"The course was well organized, with active sessions leading to open discussions. The teachers were creating an environment that was facilitating the open confrontation and providing examples in order to facilitate the comprehension."
Ilaria Giunzioni, Drug Safety Manager, Grunenthal

"I think with this course you learn a lot and is very useful for a person who is working in pharmacovigilance."
Itziar López-Oleaga, Pharmacovigilance Technician, PHARMAMAR

内容纲要

Definitions and Methods in Pharmacovigilance
Regulatory Aspects in Pharmacovigilance and Practial Examples
Diagnosis of Adverse Drug Reactions
Signal Detection and Signal Management

Modern Technologies and Social Media

Risk Management

谁应该参加？

Professionals involved in pharmacovigilance and namely Qualified Persons for Pharmacovigilance (EU QPPV), clinical research, regulatory affairs, risk management, medical product safety assessment, data analysis, epidemiology, labelling, quality assurance, compliance, and medical information.

Level: Intermediate

学习目标

For the five key topics as outlined above, the learning objectives also include the ability to:

Describe the expedited and periodic ICSRs reporting requirements in clinical trials and post-marketing including the medical evaluation
Understand the process of audits and inspections in pharmacovigilance
Understand the principles of signal management
Describe the components of the risk management

项目委员会

Gaby L. Danan, MD, PHD Pharmacovigilance Expert
GLD, France
Phil Tregunno Deputy Director - Patient Safety Monitoring
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Digital Learning Catalog

Download

Joint MHRA/DIA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing