Begin a career in the rapidly expanding clinical research industry. In this twelfth session of the series, we will delve into specific practices and safeguards used to protect patients from known and unknown safety risks from new medications.
Upon completion of this course, you will be able to: discuss ways in which the safety of a new medication is characterized; discuss safety risk management through the clinical development and post-marketing phases, including AE reporting, trial discontinuation, risk evaluation and mitigation strategies (REMS), and post-marketing studies; discuss safety implication of off-label use; and, describe label expansion studies, Rx-to-OTC switch studies, and label expansion/lifecycle management approaches.
Attend only the sessions that interest you most, or register for all 12 sessions for the price of 10. Attend 10 sessions to receive a Professional Certificate of Completion in Clinical Research Foundations.