Details the role of the
Table of Contents
Part 1: The Role of PM in Drug Development
I. Overview of Drug Development
II. Project Management’s Place in Drug Development and the Various PM Roles in Biopharma
III. Project Teams
IV. The Project Management Office
V. Project Portfolio Management
Part 2: Contemporary Topics in Drug Development
I. Managing Projects with an Agile Mindset
II. Managing International Projects
III. Managing Combination Drug-Device Projects
IV. How Technology Can Assist Project Managers Now and in the Future
V. Assessing, Selecting, and Implementing a Project Management Information System
VI. Creating an Asset Development Plan
VII. Creating a Clinical Development Plan
VIII. Creating a Market Application Submission
Part 3: GRIDALL: A Comprehensive Framework for Managing Projects
I. Introduction to GRIDALL
II. Goals
III. Risks
IV. Issues
V. Decisions
VI. Actions
VII. Lessons Learned