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Informing Regulatory and Health Technology Assessment (HTA) Decision-making Processes: An Integrated Approach to Life Cycle Management

Track:
Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)

Day & Time:
June 26, 4:00PM - 5:30PM

Session Number:
380

Room Number:
151B

Level:
Intermediate

Type:
Symposium

Title:
Informing Regulatory and Health Technology Assessment (HTA) Decision-making Processes: An Integrated Approach to Life Cycle Management

Chair(s):
Larry Liberti, MS,RPh,RAC
Director
Centre For Innovation In Regulatory Science (CIRS), United States

Description:
A health technology assessment (HTA) is used to inform reimbursement decisions. However, because approaches are diverse, opportunities to share scientific information and best practices should be explored. This symposium aims to identify the process available to assess the value of medicines in real-world practice.

Learning Objective(s):
Identify similarities among regulatory and health technology assessment (HTA) agencies that can facilitate information sharing; Discuss how advances in HTA in the emerging markets support product life cycle management; Describe the role of Performance Based Agreements postmarketing data collection and analysis in characterizing products throughout their life cycle; Recognize how to apply industry-based experience into value-based decision making to lifecycle management.

Presentation(s) & Speaker(s):
Real-world Evidence Market Impact: An Evolving Lens
Mitch Dekoven, MHA
Director - Health Economics and Outcomes Research
IMS Health, United States

Recent Developments in the HTA Landscape
Carl DeMoor, PhD
Vice President Epidemiology NA
REGISTRAT MAPI, United States

How Can Information Sharing Be Facilitated Across Sponsors, Regulatory and HTA Agencies?
Larry Liberti, MS,RPh,RAC
Director
Centre For Innovation In Regulatory Science (CIRS), United States

Legislation and Practice of HTA in Asia Pacific: Impacts on Public Health and Product Life Cycle Management
Chih-Hwa Wallace Lin, PhD
Director, Division of Resource Development
Center for Drug Evaluation, Taiwan

© 2013 DIA