About the Workshop
Are you new to the pharmaceuticals and the biotech industry? Do you want to understand how you can translate your project and program management skills for drug and medical device development? Would you like to get a refresher on the medical device and drug development process? Would you like to learn more about cross-functional activities and how you can be more effective on your project team?
This course will provide an overview of pharmaceutical and medical device development from discovery and concept development to commercialization. We will review the high-level FDA requirements for drug and medical device development, regulatory compliance and approval, including elements of design controls. The course will also discuss the important interactions with the FDA and review groups, high-level cross-functional activities of the project team, including the role of project management, and key decisions required at each phase of drug development.
