contents Instructions for use composition Dr. med. S. Kienzle-Horn Dr. med. R. Hennig Log-in for employees Dosage form production method Contact Impressum 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 Page overview Additional information Newsletter glossary Data protection Search results PV News ...Order here Upcoming events Composition | Dosage form | Mode of action | Application areas | Dosage instructions Top of the page September 07, 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 > Sitemap Contact / Imprint Glossary SiteMap Search Instructions for use English version

Further areas of application of SCRATCH Pharmacovigilance GmbH is still approved for the following areas of application: Availability / management of an inspected safety database that can report electronically - if necessary, we can also enter your cases in your database Management of individual cases, including inquiries and reporting to regulators, for serious adverse events from clinical research and for cases from the post-marketing area - this also includes the increasingly important area of those cases that are NOT adverse drug reactions, e.g. pregnancies, drug abuse, Misuse etc. Management / implementation of Drug Safety Monitoring Boards (DSMBs) Creation and continuous maintenance of the Detailed Description of the Pharmacovigilance System (DDPS) Interface management of technical complaints / pharmacovigilance Answering pharmacovigilance inquiries and procedures from regulators, e.g. EU referrals (step-by-step procedure) and recalls PV due diligence, e.g. before product license purchases or company takeovers Interim PV management or operational support Pharmacovigilance training (more ...) Risk simulations Management coaching / strategic PV consulting This is part of our offer. If you have any further questions or are dealing with a specific topic that you need support with - give us a call. Or write us an email. PV News ...Order here Upcoming events Risk Management Plan | PV inspections | Safety Reports | QPPV / PV system | more ... To the top of the page 15th 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 > Areas of application > more ... Contact / Imprint Glossary SiteMap Search Instructions for use English version