PIPA News

Improving Follow-Up Rates in Spontaneous Adverse Drug Reaction Reporting

Mon, 18 Jan 2010 00:00:00 +0000

British researchers have developed targeted follow-up letters designed to make it easier for regulators to obtain important follow-up information after spontaneous reports of suspected adverse drug reactions.

Evaluation of Post-Authorization Safety Studies in the First Cohort of EU Risk Management Plans at Time of Regulatory Approval

Mon, 18 Jan 2010 00:00:00 +0000

The EU Risk Management Plans (EU-RMPs) have been a required part of a marketing application for all new chemical entities in the European Union since 2005.

Latest report from the Council of the European Union Working Party on Pharmaceuticals and Medical Devices on the pharmacovigilance proposals.

Wed, 13 Jan 2010 00:00:00 +0000