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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Advancing Endpoint Adjudication

Session Chair(s)

Jonathan  Seltzer, MD, MA, MBA, FACC

Jonathan Seltzer, MD, MA, MBA, FACC

Chief Scientific Officer

WCG, United States

CRO, sponsor, and agency perspectives on the evolution of clinical endpoint adjudication committees (EACs) will elucidate relevant definitions and emerging requirements substantiated by case studies and metrics from dozens of global programs/projects.

Learning Objective : Describe the rationale for convening an endpoint adjudication committee (EAC); Recognize the principal regulatory and practical considerations underlying a well-run EAC from CRO, sponsor, and agency perspectives; Identify and discuss how to apply at least three EAC best practices into clinical development.

Speaker(s)

Douglas  Burgener

Panelist

Douglas Burgener

Biofourmis, United States

Sr. Marketing Director

Debra  Montgomery, MSN, RN

Panelist

Debra Montgomery, MSN, RN

Duke Clinical Research Institute, United States

eCRF Librarian, CDS III

Nicole  Pushlar

Panelist

Nicole Pushlar

Boehringer Ingelheim Pharmaceuticals, Inc., United States

Clinical Scientist, Clinical Trial Management

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