Wednesday, September 12, 2018 | 11:00 AM PST / 2:00 PM EST

Duration: 60 Minutes

Level: Intermediate


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Description

This topic will introduce the concept of using a clinical endpoint committee, including familiarization with regulatory guidance, decision factors leading to its use, the methods by which they can be done, and the common practices and pitfalls in event processing.

Learning Objectives

  • Methods by which adjudicable events can be identified
  • Different ways that adjudication of endpoints can be complete
  • Non-clinical endpoints

Speaker

Kyoko brings a wealth of expertise to the area of clinical safety. With more than 30 years of clinical research experience, she has done it all—clinical research nursing in academic and outpatient settings. She also worked at two major medical device manufacturers and most recently, at an international CRO.  Kyoko has managed Safety from clinical trial to post-marketing in the US, EMEA, and Asia Pac geographies.  Her most recent role was Director of Safety and Pharmacovigilance.   Kyoko is fluent in Japanese and has managed entire Japanese programs including PMDA reporting.


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Who should attend?

Senior professionals working with adverse events reporting:

  • Clinical Scientist
  • Clinical Safety Specialist
  • Clinical Trial Project Managers
  • Clinical Data Managers
  • Clinical Research Associates (CRAs)
  • Medical Monitors
  • Drug Safety Specialist
  • Pharmacovigilance Professionals

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