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9th International Conference and Exhibition on Pharmacovigilance & Drug Safety

Munich, Germany

Anna Stahl

Anna Stahl

Otsuka Novel Products GmbH, Germany

Title: The fundamentals and importance of accurate medical review

Biography

Biography: Anna Stahl

Abstract

Case quality is founded on accurate medical review and this quality ultimately translates into all subsequent activities, i.e. aggregate reports, signal management and all other product safety activities.

Accurate medical review starts with source data verification, triage – preliminary medical review, and data entry (relevant laboratory data, medical history etc. to be medically justified and entered, correct AE coding).

Ultimately these activities translate into a justified medical review statement which is disclosing the rationale why the adverse event is assessed as related or not related.