Project Management for Drug Developers

Project Management for Drug Developers

Stalder, Joseph P.

Taylor & Francis Ltd

10/2024

288

Mole

9781032129204

Pré-lançamento - envio 15 a 20 dias após a sua edição

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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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Drug development;Commercial and medical affairs;Project managers in the pharmaceutical and biotech industry;Regulatory submission and commercialization;Regulatory deliverables;Project Management Information Systems;Project Manager;Development Project Manager;Clinical Development Plan;TPP;Biopharma Company;PMI;Project Management Solution;Project Portfolio Management;PMDA;Regulatory Project Manager;Quality Target Product Profile;Cycle Time;Sub-team Leader;MAA;PMO Leader;HBR;Project Management Methodologies;Clinical Trial Dataset;Project Team;Vice Versa;FPI;Project Management Tool;Project Manager Care