Overview

Learn about the fundamentals of clinical drug safety and the key tools available for postmarketing pharmacovigilance. Discuss the application and inter-relationships of these tools, and consider future directions for the field. Gain knowledge of the latest changes in the US and EU regulations and best practices for compliance. Develop an in-depth understanding of the requirements and procedures that must be performed to protect patient safety and to remain in compliance with legal obligations in two key regulatory jurisdictions. Didactic presentations will be supplemented with case studies and practical exercises to reinforce learning. There will be ample time for Q&A with faculty.

Course Level: Intermediate

What you will learn

The origins and evolution of drug safety, including consensus groups, key legislation, global standards, and how to speak the language of pharmacovigilance
US and European postmarketing pharmacovigilance requirements, with a focus on traditional medicines and therapeutic biologicals
Pragmatic approaches to individual case processing and aggregate data submissions
Information technology, data protection needs, and ethical issues associated with drug safety
The basics of drug safety inspections, including case studies
The anticipated future direction of travel for post-marketing pharmacovigilance requirements

Who should attend?

Professionals who work in:

Global drug safety, pharmacovigilance, and risk management
Regulatory or legal affairs
CROs, start-ups, small companies, or generic drug companies
SOP development or quality systems
Areas responsible for training and teaching of drug safety and pharmacovigilance
Clinical health care
Out-licensing or in-licensing of biopharmaceutical products
Outsourcing or off-shoring of drug safety activities
Supervisory capacities in drug safety or functions related to pharmacovigilance
Patient advocates

This training course is also designed to provide the basics for those seeking a career change into a pharmacovigilance function.

Learning objectives

At the conclusion of this activity, participants should be able to:

Identify the legal and regulatory basis of postmarketing drug safety and pharmacovigilance
Explain the requirements, changes, pitfalls and risks in postmarketing pharmacovigilance, and apply the knowledge gained in your daily pharmacovigilance functions
Describe your company’s drug safety system and determine whether it is meeting regulatory compliance needs and requirements
Describe how your pharmacovigilance system will perform on an audit or governmental inspection

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