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Good Regulatory Practice (GRP): A Regulatory Affairs Quality System for the 21st Century
Session Chair(s)
Peter Deegan, MBA
Director
QMSPharma Limited, United Kingdom
Regulatory affairs stands in the center of the business value-chain. The session discusses how a formal Good Regulatory Practice Quality System will de-risk key commercial strategies and increase the value-proposition of the regulatory function.
Learning Objective : Identify the regulatory processes that have impact on the regulatory value chain; Define a risk map and an improvement program that will de-risk both development and commercial regulatory plans; Discuss how GRP can enable an outsourcing solution; Describe a GRP QA audit plan; Describe how GRP can increase value-proposition of the regulatory function; Discuss what industry opportunities GRP may hold if adopted more broadly.
Speaker(s)
Good Regulatory Practice: De-risking the Development and Commercial Strategies
Peter Deegan, MBA
QMSPharma Limited, United Kingdom
Director
How Good Regulatory Practice (GRP) Can Enable an Outsourced Regulatory Solution
Jean Samuel
Kinapse Ltd, United Kingdom
Chief Quality Officer
How to Audit a Regulatory Affairs Value Chain
Theresa R Haughey, MBA
GlaxoSmithKline, United States
Senior Director, Regulatory Affairs Quality Assurance
注册方法
Registration override should work.