DIA
Drug Information Association Logo
« Back to Listing

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 Safyurtlu
Allergan, Inc., United States