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Evolving Clinical Trial Guidance and Regulations: Am I Ready?
Session Chair(s)
Liz Wool, BSN
President
Wool Consulting Group Inc., United States
This session will include an overview of the ICH E6 addendum and EU Clinical Trial Regulation 536/2014 and a practical demonstration of how to perform an impact assessment to existing processes and procedures.
Learning Objective : Describe the changes and assess the impact to existing procedures and processes
Speaker(s)
ICH GCP E6 R2 Addendum Overview and Impact Assessment
Liz Wool, BSN
Wool Consulting Group Inc., United States
President
EU Clinical Trial Regulation 536/2014 Overview and Impact Assessment
Mary Mills, RN
Mary Mills & Associates, LLC, United States
President
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