Overview

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.

It is also possible to register for each of the 4 course modules separately:
Module 1: Definitions and Methods in Pharmacovigilance
Module 2: Regulatory Aspects in Pharmacovigilance and Practical Examples
Module 3: Signal Detection and Management
Module 4: Risk Management

"Very well organized course that covered the basics of PV. Materials seemed good but I did not use them during the lectures because most of the presentations were interactive and the faculty was presenting their topics very well."
Martti Ahtola, PV Network Coordinator, European Pharminvent Services

"Very valuable! Useful insight of both regulator/ industry perspective & good cover across all areas of PV. Case studies & interactive examples were great to enhance understanding."

What you will learn

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

Modern Technologies and Social Media

Risk Management

Who should attend?

This course will benefit professionals with minimum 1-2 year experience in Pharmacovigilance or adjacent functions, for example, PV Officers, PV Specialists, PV Experts, PV Coordinators, Heads/Directors/Managers of Regulatory Compliance, Quality or Safety departments.
Level: Intermediate

Learning objectives

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

Program Committee

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

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