Journal of Pharmacovigilance

The fundamentals and importance of accurate medical review

9^th International Conference and Exhibition on Pharmacovigilance & Drug Safety

July 17-18, 2017 Munich, Germany

Anna Helena Stahl

Otsuka Novel Products GmbH, Germany

Scientific Tracks Abstracts: J Pharmacovigil

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.

Biography :

In 2010, Anna completed her Doctor of Veterinary Medicine in equine internal medicine and cardiology from the Ludwig Maximilian University in Munich, Germany. With over five years of professional experience as a Safety Physician and Drug Safety Manager, Anna currently delivers high quality pharmacovigilance and risk management expertise to Otsuka Novel Products GmbH for multi-drug resistance tuberculosis (MDR-TB). Effective, timely, and benefit risk balanced treatment of MDR-TB poses unique challenges because this disease area involves drug mobilization primarily through compassionate use and expanded access programs. In particular, Anna has contributed significantly to the global medical safety strategy for MDR-TB by setting up, improving and implementing various safety management processes. Besides safety management, her main area of interest has always been medical review, including process and content wise efficient and accurate implementation on global level. Her interests include travelling, golfing, skiing and riding.

Email: astahl@otsuka-onpg.com