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OPTIMISING REGULATORY OPERATIONS THROUGH USE OF INFORMATION TECHNOLOGY

Track:
Regulatory Science

Day & Time:
March 27, 2:00PM - 3:30PM (Central European Standard Time)

Session Number:
0107

Room Number:
Room E1

Type:
Session

Title:
OPTIMISING REGULATORY OPERATIONS THROUGH USE OF INFORMATION TECHNOLOGY

Chair(s):
John W. Kiser, MSc
Senior Director, Regulatory Operations
Abbvie Ltd., United States

Description:
This session will present information on how the regulatory environment can evolve by embracing a new paradigm for worldwide regulatory submissions enabled by information technology, what are the business drivers, what are the perceived cost and business benefits, what are the major barriers and enablers. In the regulatory environment, balancing the need to be product focused while meeting the needs of all national regulators is key, the process for prioritising and producing and customising dossiers needs to be reconsidered, access to the company systems and the company knowledge base may change and maintaining validated business processes and technology systems can be seen as a major challenge.

Presentation(s) & Speaker(s):
Globally Integrated Operations: How to develop a new regulatory model that reduces cost of operations and enables regulatory strategists to focus on product strategy, compliance and regulators
Katy Juliet Page, MBA
Senior Director Submissions and Operations Support
Pfizer Ltd, United Kingdom

Using a Hub and Spoke Model to Drive Efficiency and Cost-Effectiveness in the Global Regulatory Process
Peter Lassoff
Vice President and Head, Global Regulatory Affairs
Quintiles Inc., United Kingdom

Regulator Evolution - impact of technological change on the development and approval process, covering EU Telematics Roadmap, what this means for organisations, status with e-submissions around the globe and how this enables regulator evolution
Hans van Bruggen, MSc
Director and Senior Regulatory Affairs Consultant
eCTDconsultancy and Qdossier, Netherlands