Tag Archive: safety

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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Operational Tweaks Can Greatly Reduce PHI Breach Risk

After four years of anticipation, 45 CFR Parts 160 and 164, or HIPAA’s Ominibus Rule as it is more commonly known, went into effect on March 26, 2013, with corporate compliance required by September 23, 2013. Omnibus puts into law many things left unclear in previous HIPAA-related rulings, including requiring[…]

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