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REGULATORY INTELLIGENCE INPUT INTO DEVELOPMENT STRATEGIES

Track:
Knowledge Management and Regulatory/Competitive Intelligence

Day & Time:
March 26, 2:00PM - 3:30PM (Central European Standard Time)

Session Number:
1603

Room Number:
6AB

Type:
Session

Title:
REGULATORY INTELLIGENCE INPUT INTO DEVELOPMENT STRATEGIES

Chair(s):
Christine Mayer-Nicolai, PharmD
Head Europe, Global Regulatory & Scientific Policy
Merck KgaA, Germany

Description:
This session will provide insights into how regulatory intelligence can provide a deeper understanding and valuable metrics as a sound basis for product development and regulatory strategies. Different perspectives of involved parties like the scientific Escher project, a consultant and a pharmaceutical company will be presented.

Presentation(s) & Speaker(s):
Scientific approach: Regulatory Science and Methods: How to generate tangible results
Jean Philippe de Jong, DrMed, MD, PhD, MA, MSc
Project Leader, Exon Consultancy
The Escher Project, Netherlands

Synergies of Public Affairs and Regulatory Affairs functions – how to maximize internal coordination and external impact?
Anna Hallersten, MSc
Public Affairs Director
SFL Regulatory Affairs & Scientific Communication Ltd, Switzerland

Industry point of view: Regulatory Intelligence input for development and regulatory strategy
Clare Lavery, MS
Director
Janssen Pharmaceutical Companies of Johnson & Johnson, United Kingdom