New Drug Product Development & Lifecycle Management

At the end of this two-day course, you will be able to explain the phases, major work streams, key players and interrelationships within the new drug development and lifecycle management processes. Interactive exercises include creating a simple drug development plan based on the desired target product profile.

WHAT YOU WILL LEARN

·          Drug development process

·          Phase 1

·          Phase 2

·          Phase 3 and regulatory review

·          Phase 4 and lifecycle management

• Explain how a desired drug product label dictates the components of the drug development plan
• Identify the 5 major workstreams that must be completed in any drug development program and describe their interactions
• Create the timeline for key functional area players in the 6 phases of drug development
• Discuss the life cycle management process and how product line extensions are developed
• Identify the differences among drug, biologic, and drug device development and recognize where to find additional information on biologic and drug device development