DIA 2017 Annual Meeting

Safety evaluation is a continuous process taking place throughout the life cycle of a medical product. Safety concerns have often been the primary driver in stopping or delaying development for many drug candidates. The lack of necessary safety data can compromise the regulatory acceptance of a program or a decision on a drug reimbursement. What are the different sources of safety data? How can one gather the necessary safety information without adding too much to drug development cost and without delaying the process of taking the effective medicine to a patient? In this session, presenters will review different sources of safety data and present medical considerations and statistical strategies of looking at pre-marketing stage of drug development, post-marketing safety surveillance, and other sources of real world data, and discuss how to use the totality of information to generate evidence for regulators, payers, physicians, and patients.