Tag Archive: reporting

Reporting and Not Reporting Data

Bart Cobert discusses the importance of clinical safety reporting. Not only is this a legal responsibility but also an ethical one.

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Interim ICSR Reporting in the EU for Marketed Products

At the beginning of 2013 the EMA put in place the new reporting requirements for individual case safety reports of adverse events for marketed products.  The requirements in Volume 9A were ended and the new ones noted in “Module VI-Management and reporting of adverse reactions to medicinal products”. These requirements[…]

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As an industry leader in business process outsourcing, HCL Technologies delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.

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