Resource Center: Project Management

Information Technology Project Management Resources

• General Project Management Resources
• Templates and Methodologies
• Pharmaceutical Industry and Project Management Associations
• Project Management, Requirements Management, and Quality Assurance Tools
• Articles, Presentations, and Webcasts
• Conferences
• FDA Guidance

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Pharmaceutical Industry and Project Management Associations

Project Management Institute
"PMI stands as a global leader in the development of standards for the practice of project management. Our premiere standards document, A Guide to the Project Management Body of Knowledge (PMBOK® Guide), is recognized throughout the world as a standard for managing projects in today's marketplace." "PMI's Project Management Professional (PMP®) certification is the preeminent professional credential for individuals associated with project management." The site includes a variety of project management resources, papers, and publications.
• http://www.pmi.org

PMI Pharmaceutical Special Interest Group
"We provide a unique opportunity for project management professionals in the pharmaceutical, bio-tech, contract research, and medical device industries to network with and learn from one another."
• http://www.pharmasig.org/

PMI Delaware Valley Chapter
The Delaware Valley Chapter of the PMI serves the Greater Philadelphia Area, South Jersey, Delaware and Northern Maryland.
• http://www.pmi-dvc.org

DIA (Drug Information Association)
"DIA is a professional association of approximately 20,000 members worldwide who are involved in the discovery, development, regulation, surveillance, or marketing of pharmaceuticals or related products." DIA offers a number of seminars, webinars, training, and networking opportunities.
• http://www.diahome.org/

Society for Clinical Data Management
"The Society for Clinical Data Management (SCDM) is a non-profit professional society founded to advance the discipline of Clinical Data Management."
• http://www.scdm.org

Association for Clinical Research Professionals
"ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology, and medical device industries, as well as those in hospital, academic medical centers, and physician office settings."
• http://www.acrpnet.org/

Institute for Validation Technology
"As publisher of the Journal of Validation Technology® and the Journal of GXP Compliance®, we are dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries."
• http://www.ivthome.com

Articles, Presentations, and Webcasts

Articles
Below are a few recently archived articles that discuss current trends in project management.

• Drug Giant Eli Lilly Outsources Clinical Data To India
• IMS Health Sees 5%-6% Growth for Global Pharmaceutical Market in 07
• A GCP Primer:Understanding The Basic Application Of Good Clinical Practice In The Regulated Environment For The Quality Professional
• 2006 DIA, Round II: Clinical Data Management Is a Dead Career
• In Depth: U.S. IT Unemployment Plunges To 2.2%. But There's More To This Story
• The speed of change. PM Network, April 2006, volume 20, number 4, pages 42-46 (PMI membership required for access)

Periodicals
Following are some periodicals which focus on project management, the pharmaceutical industry, and information technology.

• PM Network
• InformationWeek
• Healthcare Informatics
• Bio-IT World
• Software Development
• The Rational Edge
• Advanstar Communications
       Advanstar offers a number of publications, including:

• Applied Clinical Trials - The Global Guide to Clinical Trials Management
• BioPharm International - The Applied Technologies of Biopharmaceutical Development·     
• Pharmaceutical Executive - A Global Business and Marketing Publication
• Pharmaceutical Technology

Webinars
PMI Pharmaceutical Special Interest Group regularly offers project management webinars - Click on Webinars. PharmaSIG membership is required.

Upcoming IT Management and Health and Life Sciences webinars from BetterManagement.com

Conferences
Below is a list of recurring project management conferences:

• 2nd Annual DIA Project Management SIAC & PMI Pharmaceutical SIG Conference
  

FDA Guidance
Following is a small subset of frequently referenced FDA guidance.

General Principles of Software Validation - January, 2002
This document provides guidance for development of validated software (i.e. software that is fit for its intended use).
• http://www.fda.gov/cdrh/comp/guidance/938.pdf

Computerized Systems Used in Clinical Trials - April, 1999
This document provides guidance for development...
• http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.pdf

Draft Guidance - Computerized Systems Used in Clinical Trials - September, 2004
This document provides guidance for development...
• http://www.fda.gov/cder/guidance/6032dft.pdf

Electronic Records and Electronic Signatures (21 CFR Part 11)
The following describe the FDA’s rule for implementing electronic records and electronic signatures and provide guidance for applying the rule known as 21 CFR Part 11.
• http://www.fda.gov/ora/compliance_ref/part11/

Glossary of Computerized System and Software Development Terminology
This document is referenced in many of the FDA’s guidance documents.
• http://www.fda.gov/ora/inspect_ref/igs/gloss.html

A list of all the FDA’s current guidance documents is available here.
• http://www.fda.gov/cder/guidance/