Robust data to support a thorough benefit - risk assessment is one of the most important deliverables when submitting your application for marketing approval or label extension.
One main factor forming the basis of this is a sound reporting process for adverse events in your clinical studies. This becomes even more crucial when clinical studies are outsourced or when a group of investigators is the sponsor of your pivotal trial (IST – investigator sponsored trial). In addition, spontaneous cases have to be reported diligently to the Competent Authorities within stringent timelines. In the new EU pharmacovigilance legislation that has become effective 1st July 2012, there is an explicit call for an established and robust Quality System for the performance of pharmacovigilance activities to be implemented by the Agency (EMA), national competent authorities and marketing authorisation holders (Presentation/2011/06). This highlights the need for companies and other stakeholders to start now to build a robust QMS driving the pharmacovigilance processes.
How can Widler & Schiemann assist you with your Pharmacovigilance projects?
Over the past 6 years Widler & Schiemann have established in their former company a systematic approach to ensuring a continuous oversight on safety reporting whether in clinical trials or from spontaneous cases from marketed products. This methodology is based on the QbD and QRM principle and can be tailored to the customers' need. This QMS approach is also in line with the new EU pharmacovigilance legislation.
Widler & Schiemann will work with your experts and process owners in first analysing the current pharmacovigilance processes in your company to identifying any relevant deficiencies. By applying the QbD and QRM approaches the key process steps and related parameters will be identified and processes will be re-designed and implemented based on the first analysis.
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