DIA 48th Annual Meeting
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Regulatory Strategies to Accelerate Approval in Emerging Markets Considering the Growing Complexity of Requirements and Supply Chains
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
136
Date:
Monday, June 25, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Elaine Whiting, AstraZeneca Pharmaceuticals LP, United Kingdom
PRESENTER
(S):
Lembit Rago, World Health Organization (WHO), Switzerland Fraser Stodart, Eisai Limited, United Kingdom Francesca Cerreta, European Medicines Agency, United Kingdom
Description
This session is designed to discuss the strategies for accelerating approval and market access in emerging markets in the context of increasingly demanding regulatory requirements and the growing complexity of manufacturing supply chains.
Learning Objectives:
Evaluate the conflict between protection of the population, support for local capacity building, and access to innovative medicines
Apply the rational use of the WHO CPP Scheme in order to reduce delays in regulatory approvals.
Learning Objectives:
Evaluate the conflict between protection of the population, support for local capacity building, and access to innovative medicines
Apply the rational use of the WHO CPP Scheme in order to reduce delays in regulatory approvals.
This session is a part of:
Handout Online
