Jonathan Seltzer, MD, MBA, MA, FACC
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Assessing Cardiac Safety in Oncology Drug Development
This publication discusses emerging cardio-oncology nuances and the latest regulatory thinking on ways to manage risks.
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Q&A: The Role of Expert Committees and the Regulatory Landscape
Dr. Seltzer, president and founder of ACI Clinical, and chief scientific officer of WCG Clinical, shared his insights on expert committees during
a recent conversation with Bill Stedman.
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13:58
The Role of Expert Committees: An interview with Dr. Seltzer
What’s the role of expert committees today? What’s happening on the regulatory side? Dr. Seltzer, Chief Scientific Officer of WCG Clinical, shared his insights on expert committees during a recent...
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Unique Challenges for Medical Device Clinical Trials
Adjudication of events of interest can support overall study integrity and ensure reliable, consistent definitions are provided to regulators and the scientific community.
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Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing ev
This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled “The Role of Endpoint Adjudication in Medical Device Clinical Trials”.
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Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharrmacologic trials
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Use of Endpoint Adjudication to improve the quality and validity of endpoint assessment for Medical Device Development
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Responsibilities of Data Monitoring Committees: Consensus Recommendations
This article provides a practical guide to sponsors, institutions, and individuals responsible for, or serving on, a DMC.
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