Postapproval Safety – Not Just a Late Stage Consideration

Postapproval Safety – Not Just a Late Stage Consideration

In order for biopharmaceutical companies to gain product approval, regulatory agencies first require a series of risk evaluations. Clinical trials, for example, may be utilized in the early phases of development in order to prove a positive benefit-risk assessment. Once the product is approved, however, research is not complete. Products continue to be monitored throughout the lifecycle. In fact, a number of unanticipated/unknown safety issues may be uncovered in this stage. Although it may be impossible to anticipate the exact risks that may arise, companies can – and should – prepare.

As UBC’s Gretchen Dieck, PhD, Vice President, Safety, Epidemiology, Registries and Risk Management, will discuss next week in her webinar, the earlier a company prepares for Risk Mitigation Plans (RMP) or Risk Evaluation and Mitigation Strategies (REMs) requirements, the better. Furthermore, many options exist that can assist with your product risk management, ranging from the simple to the complex.
Join the discussion as Dr. Dieck delves into specific mitigation activities and helps biopharmaceutical companies position themselves to respond quickly and efficiently to unexpected safety issues and actively manage identified risks.

Register here for the free seminar.