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Signal Detection: Challenges and Strategic Aspects

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 18, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
319

Room Number:
30AB

Level:
Intermediate

Type:
Forum

Title:
Signal Detection: Challenges and Strategic Aspects

Chair(s):
Alan M. Hochberg
Process Development Leader
F. Hoffmann-La Roche Ltd., Switzerland

Description:
This forum will consider three aspects of signal detection which are not frequently emphasized, but which have a significant influence on the overall quality of pharmacovigilance for a product — the role of proper identification and assessment of premarketing signals in maintaining a favorable benefit-risk profile throughout a product's life cycle, the optimization of practices and systems in ambulatory and institutional settings for reporting and tracking drug-related adverse events, and the consequences for patient benefit-risk optimization of the analysis and publication of pharmacovigilance data and safety signals by a broad array of stakeholders including academic institutions, insurers, nonprofits, and web businesses, in addition to industry and regulators.

Learning Objective(s):
Identify opportunities, limitations, and challenges of premarketing signal detection; Describe best practices for product-specific safety monitoring in ambulatory and institutional settings; Recognize various pharmacovigilance stakeholders, their motivations, and their individual advantages and disadvantages as providers of drug safety information.

Presentation(s) & Speaker(s):
Premarketing Signaling: The What's, Why's and How's
Michael J. Klepper, MD
President and Founder
Drug Safety Navigator, United States

Optimizing Product Specific Safety Monitoring
Stella Stergiopoulos
Senior Project Manager
Tufts Center for the Study of Drug Development, United States

Who Should Do Safety Signal Detection and Why (or Why Not)?
Alan M. Hochberg
Process Development Leader
F. Hoffmann-La Roche Ltd., Switzerland