Schulungen, praktische Hilfen
Institut für Arzneimittelsicherheit
Gutachten, Klinische Studien, Statistik und Epidemiologie
Practical Help
- Consulting in „Expedited Reporting“ of serious adverse reactions, SAR (15 days or 7 days reports), especially in „not labelled“ reactions – SUSAR – to be reported to authorities and Ethics Committees according to the European Directive 20/2001/EC, FDA and/or local laws, respectively
- Electronic Reporting Systems: central reporting of SUSAR to the EMEA; support and consulting in the development / selection / validation of systems
- PhV System Audits
- Support in preparing for PhV inspections by the authorities (EMEA, FDA, BfArM,) according to the respective guidelines and local laws
- SOPs for a PhV System (also for Data Management, Statistics, Computer Systems Validation etc.)
- PhV Planning according to ICH Note for Guidance, Topic E2E, which requires PhV plans for each particular drug:
- Preparation of PhV Plans
- Prospective Risk Management
Trainings
- SchulungenOn the correct practice with terms: differentiation between „pure“ events, AE/SAE and adverse reactions, AR, SAR. What are „unexpected adverse reactions? What are SUSAR? (see:: „Short Glossary“)
- Training in interpretation of the local laws and international Guidelines and Directives (GCP, EMEA, FDA, German AMG etc.)
(see: „Notes for Guidances / Guidelines / Directives“ for downloading) download) - Statistical aspects of the analysis of adverse reactions, signal detection etc.
(see: „Cooperation with other institutions“)
WHO definition of pharmacovigilance: “ … The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem …“ (The Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring: The Importance of Pharmacovigilance, 2002)
Phone
+ 49 5151 925633
Adress
Niederdorf 3
31789 Hameln
Deutschland
kaiser@arzneimittelinstitut.de
Accessibility
Mo – Fr: 8 – 17 Uhr