AMERICAN PROGRAMME IN PHARMACOVIGILANCE

DESCRIPTION

This course domain covers the Basic Pharmacovigilance and Pharmacovigilance Regulations, the Pharmacovigilance for Biologics, the External databases - RWD - RWE and the Benefit Risk Assessment.

North America, pharmacovigilance, FDA, FAERS, United States, safety, management, communication, aggregate, reporting, ADR, gene therapy

Courses offer
available for this domain

Short Courses

Certificates

OBJECTIVES

To know the requirements for Pharmacovigilance in the United States as compared to the ones in the European Union, for Pre-approval and Post-approval
To know the requirements for Pharmacovigilance in the United States as compared to the ones in the European Union, for Pre-approval and Post-approval
To have an overview of the safety communication processes and the safety risk management approach, including the safety label change process
To know how to describe the measures of the incidence of a given adverse drug reaction (ADR)
To know the US aggregate reporting requirements
To have an overview of the different aspects of pharmacovigilance for vaccines and biologics.
To know the US regulators on Gene Therapy and EMA perspective of the advance therapies.
To have an overview of the FAERS database and the FDA Sentinel System
To know the technical evolution of databases as well as the new possibilities to analyze them has added new information sources to obtain valuable data describing the consumption of medicines at different levels
To have an introduction into the principles and methods of comparative Benefit-Risk assessment and their role of benefit-risk assessment in decision-making of medicines.
To know the Risk Management Plan and REMS principles