Applying Risk Management Plan Strategies to Project Management /Monitoring in EDC and eTMF global clinical trials

Time

Tue, Mar 05 8:30AM
6

Title

Applying Risk Management Plan Strategies to Project Management /Monitoring in EDC and eTMF global clinical trials

Abstract Summary

Information compiled from articles on Risk Management Plans including ICH Harmonised Tripartite Guideline-Pharmacovigilance Planning, EMA Guideline -Risk Management Systems for Medicinal Products,FDA Guidance for Industry Development and Use of Risk Minimization Action Plans/Mitigation Strategy.

Poster Presenter

Sherri A. Hubby
Senior Director, US Quality Assurance,
Premier Research Group Ltd.
United States

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