Decision Points in Pharmaceutical Development: Distance Education Course (updated)

This introductory course focuses on the critical decisions made during a question-based label-driven approach to development of a pharmaceutical candidate from discovery through to product launch and marketing. The course highlights the decisions involved in the identification of a lead pharmaceutical candidate, conducting preclinical work to provide safety data to support the initial human clinical studies, establishing optimal therapeutic doses with an acceptable benefit-to-risk ratio, generating a label, and deciding to file an NDA or BLA. A key element of the module is a discussion of how the development of a pharmaceutical candidate is a stepwise approach of learning, confirming and affirming that together with the product label drives the pharmaceutical development process.

You should expect to spend approximately 6 hours of study time to complete the course.

Please allow up to 24 hours to receive your official course registration confirmation.