Education Sessions
Managing Clinical Stage Projects (606)
| 29 October 12.45-15.45 | Track: Project Management |
ISPE CEUs: 0.2
(PDF Current as of 2 October 2008)
The process of getting a drug to market is a vast organizational effort for many drug companies these days and speed to market is imperative. As a product moves from late stage development through phase III clinical trial management and licensing, a focused project team and effort requires managing. Finding a way to successfully transfer a Biotechnology product in to full scale phase III manufacturing, validating that process, and ultimately licensing it with a focus on reducing cost, increasing speed, and maintaining compliance, is quite a project management challenge.
How You Will Benefit
At the end of this session, participants will be able to:
- Understand the process of moving a product from development to phase III to licensing, allowing for better internal customer appreciation
- Recognize universal tools that work for capital projects regardless of type (for example, design-build, construction, commissioning, vs. product development)
- Apply new tools to standard engineering projects
Technical Documents - www.ISPE.org/publications
ISPE Good Practice Guide: Technology Transfer, and Biopharm. Manufacturing Facilities Baseline® Guide
Who Should Attend
Project managers, engineers, process and development scientists, quality control, and quality assurance
ISPE Communities of Practice (COPs)
Biotechnology (Biotech), Investigational Products (IP), Project Management (PM), and Process/Product Development (PPD)
Session Leader
- Andrew Jones, Director, Compliance, NPI, Global Biologics Supply Chain LLC, USA
Session Speakers
- Amy Barnes, Project Manager, Centocor, USA
- Julie Chester, Sr Global Bio Pipeline Manager, Recruitech International, USA