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Session 8 Track 1: Three Perspectives on Achieving Medicinal Product (Data) Quality
Session Chair(s)
Michiel Stam
Director Regulatory Information Management
Qdossier - A Celegence Company, United Kingdom
All three presenters will share different perspectives on gaining better control over Medicinal Product Quality and associated Data, utilizing the increasing amount of structured data available. What all three presentation have in common is anticipating on the global shift from primarily paper based assessments to structured data. What is the impact of these changes on the organization of the Regulatory Affairs department and related processes? What skills are required to effectively manage structured data quality during the product life cycle and what is the impact on the regulatory assessment procedures at the Health Authorities?
Learning Objective : - Integrate ideas for performance improvement and impact of the data management- and publishing team
- Recognize challenges related to the (re-)organization of people, processes and systems in data management
- Identify and share requirements for succesful RIM data management
- Understand the submission and lifecycle management of models used for the prediction of product and process quality in pharmaceutical manufacturing
Speaker(s)
Building a Culture Around Data for Successful Registration Tracking; the Transformation of a Data Management Office
Michiel Stam
Qdossier - A Celegence Company, United Kingdom
Director Regulatory Information Management
Should Publishers Become Ambassadors for Data Quality, What Might the Role of a Publisher Look Like, a Few Years from Now?
Jennie May
Regeneron, United States
Senior Manager, Regulatory Information Management
An Industry Proposal for the Registration and Lifecycle Management of Manufacturing Models
Isabelle Lequeux, MSc
Biophorum, France
Facilitator
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