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The Role of Lab Data in the Drug Development Process: Adverse Events and Subject Safety

June 21, 2013 @ 10:00 am - 2:00 pm

Why Should You Attend:

With the increasing frequency of real-time FDA audits and complexity of Investigational Medicinal Products (IMP’s), the wise are paying more attention to including a full range of lab tests to insure IMP safety. Which lab values outside of the Reference range are to be reported as AE’s is always the question.

This webinar will discuss the array of lab tests taken, as part of the clinical research safety monitoring plan, at prescribed intervals adjudged to answer the safety questions. You will learn why it is important for the whole team and the sponsor to have knowledge of the timing and extent of this testing. Participants will understand how to review the lab data and reference ranges for assurance as to the verity of what is observed. The presenter will explain how to determine an adverse event in relationship to lab data.

Areas Covered in the Webinar:

  • The purpose of the Safety Monitoring Plan in a Protocol
  • The Regulatory requirements of Adverse Event reporting
  • Studies requiring a specific type of Lab test
  • What do the “reference ranges” tell us?
  • When would an “out-of-range” lab value be an Adverse Event?
  • What types of studies depend on Laboratory and other testing?
  • Importance of good medical judgment in the process

For Registration

Details

Date:
June 21, 2013
Time:
10:00 am - 2:00 pm
Event Category: