PDF Edition - Understanding EU Drug Safety Reporting

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Are your pharmaceuticals still safe to sell in Europe?

And how can you tell?

These questions have never been timelier. The new European Pharmacovigilance Risk Assessment Committee (PRAC for short) gets closer to full operation each day. Next year, when it hits full stride, U.S. drug exporters will find themselves playing under all-new rules.

It’s time you got up to speed — and doing so has never been easier.

In an hour or two of study, you’ll gain understanding of new EU pharmacovigilance rules, from preapproval through the life of a drug, plus insight into compliance in a new era. Specifically you’ll discover:

  • How to deal with the PRAC

  • How to tailor a PRAC-ready pharmacovigilance system, including finding and appointing a new “qualified person” (QP) to oversee pharmacovigilance

  • How to adapt to broad new definitions of adverse drug reactions, including monitoring of off-label uses and misuses

  • How to prepare for safety label warning changes to accompany products whenever a regulator requests additional safety monitoring

  • And much more!

The PRAC will be responsible for investigating drug safety, reviewing risk management plans for new drugs, and advising when safety of a drug or class of drugs is in question. Will it be a tiger — or a paper tiger? You need to know — now.

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PDF Edition


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Table of Contents

  • Introduction
  • The Creation, Roles and Responsibilities of the PRAC
  • Changes in Marketing Authorization Applications
  • New Postmarket Safety Study Definition and Requirements
  • And More …

View the entire TOC

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