Tag Archive: adverse events

Excipients and Inactive Ingredients in Drugs & Drug Safety

In our world of drug safety and PV, we don’t think much about inactive ingredients and excipients found in drug products. In fact, we don’t even know which ones are in the drugs we take, make, sell and prescribe, and we may not even be sure where to find out[…]

Read More

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[…]

Read More

The Experience Matters.

As an industry leader in business process outsourcing, C3i Solutions delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.

Contact Us