The new EU pharmacovigilance directive takes effect July 12. If you don’t think you can meet that deadline ... if you have even the slightest doubt ... please read the rest of this letter now.
These new regs will force myriad changes in the way you do business in Europe. New and changed definitions. New regulatory bodies. New reporting requirements.
Right away, you’ll face two major challenges: 1) Adoption of good pharmacovigilance practices (GVP), and 2) creation of pharmacovigilance system master files to supplant detailed descriptions of pharmacovigilance systems currently in use.
Fortunately, help is at hand.
This standout new management report from FDAnews could not have come at a better moment. Just look at some of the changes you’ll face when Europe’s new European regulatory regime kicks in:
Creation of a new pharmacovigilance risk assessment committee (the so-called PRAC, comparable to an FDA risk advisory committee)
Enhanced monitoring of risk management programs to assure compliance based on a product’s marketing authorization
Requirements that you inform international regulatory bodies of safety-related issues prior to, or simultaneous with, public disclosures
Enhanced priority on signal detection, with MAHs required to evaluate all pharmacovigilance information and take necessary appropriate measures
Possible requirements for MAHs to submit protocol and progress reports to member states for Post Authorization Safety Studies (PASS)
Internet sharing of information among MAHs and regulatory authorities
The EU Pharmacovigilance: 2012 Compliance Guide is not a theoretical document, though – far from it. It’s loaded with the sort of practical how-to guidance that gets you off the bench and into the game. Guidance like:
With so much of the drug and biologics trade depending on global sales, it’d be foolhardy to stick your head in the sand regarding these new EU regs. Don’t take the risk of failing to comply. Order your copies of the 2012 Compliance Guide today.
EU Pharmacovigilance: 2012 Compliance Guide is available in print or PDF formats for $377 each.
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