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Drug Development Strategies and Incorporation of an Established Project Management System
Program Code:
350
Date:
Wednesday, June 27, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Dr. Marija Ribar is Director, Project Consultancy responsible for cross-functional team activities of all phases of drug development with support for regulatory activities. She has been involved in prep of 18 INDs/DMFs/ODD/NDAs. She has DMD degree from Belgrade University and MBA degree from NCSU.
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PRESENTER
(S):
Pete Harpum leads a consulting team supporting pharma and biotech clients of all sizes to develop world class Portfolio, Program, and Project Management capability. Harpum consulting operate in North America, Europe, the Middle East and Far East.
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Dr. Marija Ribar is Director, Project Consultancy responsible for cross-functional team activities of all phases of drug development with support for regulatory activities. She has been involved in prep of 18 INDs/DMFs/ODD/NDAs. She has DMD degree from Belgrade University and MBA degree from NCSU.
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Alexander Smith, ADS Pharma Consulting, LLC, United States
Description
This session will look at strategic planning as a foundation upon which a drug development program defines the tasks that need to be completed, when they must be completed, the associate cost, the key personnel and use of established PM system.
Learning Objectives:
Discuss program scope development including all functional areas and key stakeholders to facilitate drug development go/no go decisions
Explain project road map development including costs, timelines, quality, and risk management planning
Describe a strategic planning proposal to incorporate outsourcing models.