PTI - international

Course Description

Firms are facing the challenge of proactively assessing and managing risk and assuring safety throughout a product's lifecycle. The end goal for firms is to usher a product through all phases of development in a timely, cost-efficient manner while simultaneously striving to protect public safety. Depending on where a product is in the development cycle, if FDA uncovers safety issues, it could close down clinical studies, delay approval, or even recall the marketed product. This two-day, comprehensive training course begins with a brief introduction and overview of the principles of risk assessment, risk management and drug safety. How to assess risk and conduct product safety studies starting in the clinical stage and continuing through to the post-approval marketing stage will be reviewed. Learn best practice techniques to help adequately communicate drug safety information and risk management procedures from the clinical team to post-approval marketing team. By the end of Day Two, participants will have acquired the skills necessary to institute good pharmacovigilance practices, determine best practices for safety reporting and establish an effective risk management program. Learn from your peers and an expert instructor throughout the duration of this interactive training course.