Project Management for Drug Developers

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

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