New regulations require new proof of your risk effectiveness

If you work in drug safety you will know that all marketed drugs require an assessment of the need for a risk management plan, the first step of which is to conduct a risk assessment.  If there are no important potential risks found as a result, then it is acceptable to perform only routine pharmacovigilance.  If the assessment finds either important potential risks, or some missing information, then it becomes necessary to perform either a risk minimisation action, or conduct further studies to find the absent data.

So far, so routine.  But are you aware of the extra layer of complexity that new regulations require?

If you would like to read the article in full please click on the pdf link below:

New regulations require new proof of your risk effectiveness

or to view the magazine follow the link below, the article can be found on pages 57 and 58:

http://viewer.zmags.co.uk/showmag.php?mid=sgfgh#/page0/

About Pharma magazine
Aimed at the international pharmaceutical and bio-pharmaceutical community, Pharma magazine covers every aspect of manufacturing from R&D to finished product. With a worldwide circulation of more than 40,000 individuals it is the first truly global magazine for the pharma industry, bringing together the disciplines of discovery and development, the drug manufacturing process and the resultant business and management issues.

For further information visit the Pharma magazine website www.pharma-mag.com