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HURDLES TO OVERCOME TO ENSURE REGULATORY SUCCESS FOR THE NEXT GENERATION OF PRODUCTS

Track:
Regulatory Science

Day & Time:
March 26, 11:00AM - 12:30PM (Central European Standard Time)

Session Number:
0102

Room Number:
Room E1

Type:
Session

Title:
HURDLES TO OVERCOME TO ENSURE REGULATORY SUCCESS FOR THE NEXT GENERATION OF PRODUCTS

Chair(s):
Susan Forda, PhD, MBA
Vice President, International Regulatory Affairs
Eli Lilly & Company Ltd., United Kingdom

Description:
One of industry’s key responses to the EU’s Horizon 2020 programme is to initiate a series of work streams to investigate new models for R&D. The aim is to ensure that the development and regulatory models of the future meet the needs of all stakeholders and continue to get innovative products to patients as quickly as possible. This session will outline the business needs for change within both industry and at the regulator level and will explore what needs to be done to ensure a successful evolution.

Presentation(s) & Speaker(s):
The Business Need for Changing the R&D Model
Richard Bergstroem, MS
Director-General
EFPIA, Belgium

The Role of the 21st Century Regulator
Ian Hudson, DrMed, MD, FFPM, FRCP
Chief Executive
MHRA, United Kingdom

Innovation in Regulation to Support Innovation in Development
Isabelle Clamou
Regulatory affairs Director - EU Policy
Amgen Ltd, Belgium