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e-Business in Pharmacovigilance

The greatest challenge of the 21st Century will be the introduction of integrated e-business processes into the daily routine of pharmacovigilance for all aspects of information creation, analysis and communication. The electronic communication is, however, only the externally visible part of information handling. The better the processes that precede or follow the communication are integrated and supported by intelligent data handling or production techniques, the higher the benefit from e-business.

In pharmacovigilance the task of collection, documentation distribution and regulatory reporting of case reports on adverse experiences related to drugs by pharmaceutical companies and regulatory authorities is predominant. Though this activity is only the first step in a decision-making process to determine the risk profile and ultimately the risk benefit ratio of a drug, it devours vast resources and is in the focus of most regulatory compliance measures. Individual case safety reports (ICSR) are exchanged through a tight and highly regulated network of mutual obligations. The same case safety report will therefore appear in multiple institutions and will be entered into a database.

Every day thousands of case safety reports (adverse event reports) are distributed throughout the world. The FDA alone received 276,000 case reports in 1999. There is reason to believe that this transaction is probably the most frequent communication in the pharmaceutical world. Until now, case safety reporting relied largely on paper-based formats, such as the CIOMS, MedWatch, Yellow Card, BfArM and others.


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By Peter-Christoph Schulz, Safety Officer at Bayer Vital GmbH

Dr Peter-Christoph Schulz is the Safety Officer at Bayer Vital GmbH, the German marketing organisation for the pharmaceutical products of Bayer AG. His current responsibilities include case handling and regulatory issue management, as well as IT development.

Dr Schulz's special interests include systems analysis, process engineering and application development for cardiology (EKG, Holter Monitoring), hospitals and pharmacovigilance. After the completion of medical school and service as a Medical Officer in the army, Dr Schulz trained in internal medicine in institutions in Germany and the US.

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Dr Peter-Christoph Schulz
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