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Using a Hub and Spoke Model to Drive Efficiency and Cost-Effectiveness in the Global Regulatory Process

Track:
Regulatory Affairs and Submissions

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
292

Room Number:
10

Level:
Intermediate

Type:
Session

Title:
Using a Hub and Spoke Model to Drive Efficiency and Cost-Effectiveness in the Global Regulatory Process

Chair(s):
Peter Lassoff
Vice President and Head, Global Regulatory Affairs
Quintiles Inc., United Kingdom

Description:
As the high cost of drug development persists and regional regulations continue to be increasingly nuanced and complex, many biopharmaceutical companies are exploring innovative models that offer a smarter approach to bringing compounds to market. This session will examine a Hub and Spoke model, which has proven effective in driving a more efficient and cost-effective use of resources for regulatory activities on a global scale. This program is focused on medium to large companies.


Learning Objective(s):
Discuss the challenges driving the need for smarter, more efficient models in the regulatory process; Explain the basic structure of a Hub and Spoke model as an innovative solution to these challenges; Discuss core benefits, challenges and current limitations of this model.

Presentation(s) & Speaker(s):
Using a Hub and Spoke Model to Drive Efficiency and Cost-Effectiveness
Peter Lassoff
Vice President and Head, Global Regulatory Affairs
Quintiles Inc., United Kingdom

Effective Regulatory Information Management Leveraging a Hub and Spoke Model: An Industry Case Study
Susanne Andreae, PhD
Senior Director, Head of Regulatory Informatics and Submission Management
EMD Serono, Inc., United States

Developing an Effective Model for Global Registration Management
Bonnie L Safyurtlu, MS, RAC
Director, Regulatory Affairs
Allergan, Inc., United States