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Four Points By Sheraton Bur Dubai

Dec 12, 2016 8:00 AM - Dec 13, 2016 5:00 PM

Khalid Bin Walid Street, Bur Dubai P.O. Box 33196, Dubai, United Arab Emirates

Practical Guide for Pharmacovigilance: Clinical Trials and Post-Marketing

Pharmacovigilance practices are emerging in the Middle East as the GCC countries are implementing new safety standards based on the European GVP modules. This course is taught by Jan Petracek, former Head of Risk Management at the EMA, with insights on GVP developments and learning any safety professional will benefit from. The course walks you through the essentials of pharmacovigilance practices in pre- and post-marketing phases to enable you hit the ground running when implementing safety reporting. </P>

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Overview

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

Regional developments in the GCC countries will also be highlighted.

What you will learn

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

  • Identify the history, the principles and regulatory framework for clinical safety/pharmacovigilance

  • Discuss the basic definitions of terms used in day-to-day work with confidence

  • Understand international and regional safety surveillance requirements

  • Describe the criteria and elements of expedited and periodic reporting of drug safety from phase I
    studies to post-marketing

Who should attend?

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.

Level: Beginner

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