Testing new pharmaceuticals is inherently risky, but our library of drug safety webinars will help you minimize that risk and protect patients. From ever-evolving regulatory requirements and adverse event reporting to working with institutional review boards (IRB) and managing pharmacovigilance initiatives, there’s bound to be a topic of interest in this category.
Before a new drug is ever tested in human patients, it must undergo a series of preclinical studies, usually in animal models or in vitro cell lines, to assess its toxicological profile. Provided the results are favorable, the compound may proceed in human clinical trials involving just a few volunteer subjects.
The potential for adverse events to occur during trials is ever-present, regardless of the type of drug under study, and a certain level of risk is tolerated provided it does not outweigh the potential benefits of the therapy for patients. Conducting a benefit-risk assessment can help sponsors decide which compounds to continue developing and which programs should be stopped.
Once a new drug is approved by regulators, post-marketing studies as part of a company’s pharmacovigilance program are often required to collect real-world data on the safety of the drug and ensure any adverse events are reported. This, combined with clinical trials data, may be used to establish labeling requirements for a new drug. If the potential for adverse events is serious enough it may necessitate a Risk Evaluation and Mitigation Strategy (REMS) to ensure both prescribers and patients are aware of the most appropriate use of the drug.
Explore our catalogue of drug safety webinars below to find a topic that’s most interesting to you.