Dear visitor, please read this leaflet carefully. It contains important information about the use of . If you have any questions, please do not contact your doctor or pharmacist, but us ... The all-round carefree package for pharmacovigilance Risk Management Plan Launched just a few years ago, Risk Management Plans (RMPs) are becoming increasingly popular with the authorities. However, there is not always agreement about the objective and purpose of this document, even less about the necessity and meaningfulness of the content. More... Pharmacovigilance inspections PV inspections can be fearful. On the other hand, if well prepared and carried out, they can be intense learning experiences. They offer great potential, which unfortunately is rarely used. More... Safety reports Safety reports such as PSURs, Annual Safety Reports, Integrated Summaries of Safety (US), Clinical Summaries of Safety (Common Technical Document, EU) or the safety sections of a Clinical Study Report require care and attention to detail on the one hand, but also on the other Overview and a sense of the essentials. We offer you both. More... QPPV / pharmacovigilance system There is no doubt that the Qualified Person for Pharmacovigilance (QPPV) plays THE main role in the PV from the perspective of the European regulators. Volume 9a leaves very little room for maneuver. The PV system is also attracting more and more interest outside the EU . More than late-reported cases, more than periodic reports. Individual failures are increasingly interpreted as PV system failures. Not always right. More... PV News ...Order here Upcoming events Composition | Dosage form | Mode of action | Application areas | Dosage instructions Top of the page 19th August 2014 Copyright 2010 by SCRATCH Pharmacovigilance GmbH Register for data protection declaration composition Dr. med. S. Kienzle-Horn Dr. med. R. Hennig Dosage form production method credentials Mode of action Safety competence Risk assessment training Consulting with Heart application areas Risk Management Plan PV inspections Safety reports QPPV / PV system Further ... Dosage instructions Start > Instructions for use Contact / Imprint Glossary SiteMap Search Instructions for use English version