Adverse Event Reporting

Industry-leading growth for this biopharmaceutical company led its president and CEO to launch an aggressive Adverse Event (AE) reporting system for the company's 1,200 employees, subcontractors and partners located in the US and Europe. The AE Policy is a key aspect of the company's unwavering commitment to patient safety.

UL developed an online, scenario-based course designed for the learning needs of employees ranging from R&D and sales professionals to office administrators and manufacturing technicians. Advanced instructional design techniques including simulation and interactivity engage learners and drive comprehension of the subject matter. Testing of proficiency follows each course, with remedial instruction provided when needed to achieve 100 percent proficiency.

Within two weeks of program launch, all employees had achieved 100 percent proficiency, demonstrated by online testing. Performance was documented and stored in audit-ready format, easily accessible to corporate managers for ongoing analysis and to regulators for inspection. Through this program, a deeper understanding of the therapeutic risks and benefits of the company's drugs was comprehended and reported.