Testing new pharmaceuticals involves risk, but our drug safety webinars help you minimize that risk and protect patients. We cover topics such as evolving regulatory requirements, adverse event reporting, working with institutional review boards (IRB) and managing pharmacovigilance initiatives.

Preclinical Studies
Before testing a new drug in humans, researchers perform preclinical studies in animal models or in vitro cell lines to assess its toxicological profile. If the results prove favorable, the compound enters human clinical trials with a few volunteer subjects.

Assessing Benefit and Risk
Adverse events may occur during trials, and sponsors must tolerate some risk if benefits outweigh it. Conducting a benefit-risk assessment helps sponsors decide which compounds to continue developing and which to stop.

Post-Marketing Surveillance
After regulators approve a new drug, companies conduct post-marketing studies to gather real-world safety data and report adverse events. They use these data, along with clinical trial results, to establish labeling requirements. Serious risks may even require a Risk Evaluation and Mitigation Strategy (REMS) to guide prescribers and patients on proper use.

Explore our catalogue of drug safety webinars below to find the topic that interests you.