概要

Drug development is an incredibly complex and risky endeavor, one that even experienced organizations will fail at more often than they succeed. This course will help you understand how companies structure their efforts and utilize their resources to improve the odds of successful development, and minimize the risks associated with shepherding a new drug candidate through the development process.
At the end of this course, you will be able to explain the phases, major work streams, key players and interrelationships necessary to develop new drugs and to expand the life cycle of in-line products. Interactive exercises will take you through the many decisions faced by an organization as they progress a new drug candidate through development and beyond.
Course Level: Beginner

何を学ぶか

Drug development process
Candidate identification/preclinical testing
Phases 1, 2, 3, and 4 pertaining to regulatory review and life cycle management

参加対象

Professionals wishing to broaden their understanding of drug development in the pharmaceutical or biotechnology industry
People moving from primarily functional positions into team membership roles
People transitioning from other industries or from academia

学習目的

At the conclusion of this activity, participants should be able to:

Explain how a desired drug product label dictates the components of the drug development plan
Identify the five major work streams that must be completed in any drug development program and describe their interactions
Describe the key functional area players and when they contribute to the six phases of drug development
Discuss the life cycle management process and how product line extensions are developed
Recognize the major differences between drug, biologic, and drug device development
List where to find additional information on biologic and drug device development

New Drug Product Development and Lifecycle Management

概要

何を学ぶか

参加対象

学習目的

最新情報や機会を逃さないで