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Using a Hub and Spoke Model to Drive Efficiency and Cost-Effectiveness in the Global Regulatory Process
Session Chair(s)
Peter Lassoff, PHARMD, RPH
Senior Vice President, Head of Regulatory, Medical Writing and Regulatory Intell, Syneos Health, United Kingdom
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 : 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.
Speaker(s)
Peter Lassoff, PHARMD, RPH
Senior Vice President, Head of Regulatory, Medical Writing and Regulatory Intell, Syneos Health, United Kingdom
Using a Hub and Spoke Model to Drive Efficiency and Cost-Effectiveness
Susanne Andreae, PHD
Senior Director, Head of Regulatory Informatics and Submission Management, EMD Serono, Inc., United States
Effective Regulatory Information Management Leveraging a Hub and Spoke Model: An Industry Case Study
Bonnie Safyurtlu
Director, Global Regulatory Affairs, Abbvie, United States
Developing an Effective Model for Global Registration Management
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