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Knowledge Management for the Product Life Cycle
Session Chair(s)
Paige Kane
Regulatory Science Researcher/ Director KM CoE
Dublin Institute of Technology/ Merck & Co., Inc., United States
This session will provide an overview of the philosophy of knowledge management and its importance in life cycle management. In addition, we will focus on knowledge management as the complement to change management in a company’s pharmaceutical quality system and as a key foundational basis for the use of prior knowledge in risk assessments in the design, development and maintenance of product quality.
Learning Objective : Describe how knowledge management systems integrate information and data from multiple sources; Explain how this is used to manage product quality through its life cycle.
Speaker(s)
Recommendations for a Streamlined, Global Assessment of CMC Changes and Optimized Dossier Preparation Process
Kim Brownrigg
Accenture, United Kingdom
European Regulatory Domain Lead
Compliance and Change Control: Checking That the Manufacture/CMC is Maintained in Accord With the Terms of the License
Peter Lassoff, PharmD, RPh
Syneos Health, United Kingdom
Senior Vice President, Head of Regulatory, Medical Writing and Regulatory Intell
Implementing a Holistic Knowledge Management Strategy: A Pharmaceutical Company Case Study
Paige Kane
Dublin Institute of Technology/ Merck & Co., Inc., United States
Regulatory Science Researcher/ Director KM CoE