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Features
Includes authors' recent experience with improved tactics and technologies/software at various stages of drug development.
Provides the most up-to-date and best practices, techniques, and methodologies in project management.
Details the role of the PM at each stage of drug development, including working with the key interfaces throughout the process.
Diverse audience including nonproject managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics.
Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses.
Features
Includes authors' recent experience with improved tactics and technologies/software at various stages of drug development.
Provides the most up-to-date and best practices, techniques, and methodologies in project management.
Details the role of the PM at each stage of drug development, including working with the key interfaces throughout the process.
Diverse audience including nonproject managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics.
Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses.
Dr. Joseph P. Stalder
Joe Stalder, Pharm.D., PMP, is a Senior Director of Project Management at Mirati Therapeutics in San Diego, USA. He received his Bachelor's degree in Pharmacology from the University of California, Santa Barbara, and his Doctor of Pharmacy program at the University of California, San Diego. After receiving his PharmD, he completed a post-doctoral fellowship at Forest Laboratories in New York/ New Jersey, during which he also served as an adjunct professor at St. John's University in Queens, NY. Joe has more than 10 years of project management experience in pharmaceutical development in both large and small companies. His experiences include PM department head, PMO head, and PM Lead on several late-stage development assets in oncology, infectious disease, cardiology, metabolism, and pulmonology.
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
Erscheinungsjahr: | 2022 |
---|---|
Fachbereich: | Andere Fachgebiete |
Genre: | Medizin |
Rubrik: | Wissenschaften |
Medium: | Buch |
Inhalt: | Einband - fest (Hardcover) |
ISBN-13: | 9781032126685 |
ISBN-10: | 103212668X |
Sprache: | Englisch |
Ausstattung / Beilage: | HC gerader Rücken kaschiert |
Einband: | Gebunden |
Redaktion: | Stalder, Joseph P. |
Hersteller: | CRC Press |
Maße: | 240 x 161 x 21 mm |
Von/Mit: | Joseph P. Stalder |
Erscheinungsdatum: | 29.12.2022 |
Gewicht: | 0,639 kg |
Dr. Joseph P. Stalder
Joe Stalder, Pharm.D., PMP, is a Senior Director of Project Management at Mirati Therapeutics in San Diego, USA. He received his Bachelor's degree in Pharmacology from the University of California, Santa Barbara, and his Doctor of Pharmacy program at the University of California, San Diego. After receiving his PharmD, he completed a post-doctoral fellowship at Forest Laboratories in New York/ New Jersey, during which he also served as an adjunct professor at St. John's University in Queens, NY. Joe has more than 10 years of project management experience in pharmaceutical development in both large and small companies. His experiences include PM department head, PMO head, and PM Lead on several late-stage development assets in oncology, infectious disease, cardiology, metabolism, and pulmonology.
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
Erscheinungsjahr: | 2022 |
---|---|
Fachbereich: | Andere Fachgebiete |
Genre: | Medizin |
Rubrik: | Wissenschaften |
Medium: | Buch |
Inhalt: | Einband - fest (Hardcover) |
ISBN-13: | 9781032126685 |
ISBN-10: | 103212668X |
Sprache: | Englisch |
Ausstattung / Beilage: | HC gerader Rücken kaschiert |
Einband: | Gebunden |
Redaktion: | Stalder, Joseph P. |
Hersteller: | CRC Press |
Maße: | 240 x 161 x 21 mm |
Von/Mit: | Joseph P. Stalder |
Erscheinungsdatum: | 29.12.2022 |
Gewicht: | 0,639 kg |