AB Consulting LLC, Lansdale, Pa 19446, USA.
Adverse drug reaction reporting ,Evaluation , Company Core Data Sheet ,

Adverse drug reaction reporting is fundamental in the post marketing surveillance of a medicinal drug. It is, therefore, important to capture these information in a structured manner and to the highest possible quality standards to support accurate detection and analysis of drug safety updates. For the management of adverse events of individual drugs within a defined period in post approval clinical studies, aggregated safety reports are introduced to provide safety analysis of all adverse events received over a defined time period. To ensure convergence of local regulations and decreasing the burdens from regulators and sponsors ICHE2C is revised to ICHE2C(R2) or PBRER, which utilizes the resources efficiently and reduce the submission frequency. PBRER is based on modular approach. It evaluates the patient drug exposure data from different countries along with the stratification of special population. Data from new, ongoing, closed or completed clinical studies are examined for the true signals as well as events of interest. Systematic efforts are placed to identify new risk or any changes in the known safety profile of the product. Evaluation of the signal analyses update the safety section of various reports including Company Core Data Sheet, which allows for routine assessment and reassessment of the safety data. Overall, the PBRER is based on benefit-risk analyses of interventional and non-interventional clinical studies.

5 , 1 , 2015