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

Email

kaiser@arzneimittelinstitut.de

Accessibility

Mo – Fr: 8 – 17 Uhr

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