Arzneimittelinstitut

Institute for Drug Safety

Consulting in „Expedited Reporting“ of serious adverse reaction

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 GVP, 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, PEI) 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
your contact to us

Trainings

  • On the correct practice with terms: differentiation between „pure“ events, AE/SAE and adverse reactions, AR, SAR. What are „unexpected adverse reactions? What are SUSARs? (see:: „Short Glossary“)
  • Training in interpretation of the local laws and international Guidelines and Directives (GCP, GVP, 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)

Get in Touch

Phone: + 49 5151 925633

or send us an email