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Session 5 Track 4: Following the Sun: Regulatory Ops in Global Organization
Session Chair(s)
Christian A. Buckley, MBA, RAC
Associate Director, Regulatory Affairs
Astellas, United States
Maintaining quality submissions with an ever-growing portfolio requires an organization to utilize global publishing resources and adjust to regional workload fluctuations. Regulatory Operations can add value over the success of Regulatory Affairs and the entire company beyond just technical expertise on electronic submissions. Global submissions must be “first time right” and regulatory information must be easily and quickly available “right at your fingertips”. The current trend of globalization is an opportunity for Regulatory Operations to develop into a key position for worldwide integral and comprehensive Regulatory information and submission management.
The following areas will be discussed:
- Challenges for cooperation among a worldwide workforce
- Data quality framework and options to embed continuous data quality control
- Regulatory process owner – continuous improvement beyond compliance
- Submissions need project leaders, not super heroes
- Explore offshoring of regulatory operations as an effective solution to increasing operational demands.
Learning Objective : Understand the impact of organizational and process-related improvements to position Regulatory Operations beyond technical tasks and gain benefits for Regulatory Affairs as well as R&D
Speaker(s)
From Regulatory Operations to Integrated Regulatory Information and Submission Management
Timm Pauli
PharmaLex , United States
Head of Regulatory Operations
Cross-Continent Competence: Successes and Struggles with Offshore Regulatory Operations Support
Mary Anne Potok
MMS Holdings Inc., United States
Technical Manager, Regulatory Operations
Global Work Share – A Case Study of Utilizing Workshare Between Groups to Balance Workload
Jennifer Costello
Bristol-Myers Squibb, United States
Associate Director, Global Dossier Management
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