Searching for drug safety and benefit-risk evaluations

Scientific literature is one of the largest source of adverse event reports, making it an essential part of pharmacovigilance. Marketing authorization holders are expected to perform systematic literature searches using reference databases and local journals from countries where the medicinal product has a marketing authorization. The retrieved information needs to be collated, analyzed, and communicated at least once a week. However, several challenges are associated with this process. Large amounts of data from various sources, various regulatory requirements, building and maintaining search strategies increase the complexity of literature searches. In this webinar, Scientific Information Expert Dr. Jean-Dominique Pierret will give a brief overview of regulatory obligations and usefulness of literature in the drug development process. And then he will introduce how he set up literature search for pharmacovigilance: such as selecting the databases, building the strategy with a focus on early detection of safety issue and benefit/risk assessment. Finally, he will give examples of challenges that may occur during literature search for pharmacovigilance. About the speaker: Dr. Jean-Dominique Pierret is a Scientific Information Expert and he spent +20 years in the pharmaceutical industry. He is currently working for Galderma R&D. With a strong background in information sciences applied to the biomedical domain, he is involved in the management of a corporate scientific library, in competitive intelligence and in information retrieval. Jean-Dominique is in charge for years of the literature survey for pharmacovigilance.