Understanding EU Drug Safety Reporting
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:
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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