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Session Chair(s)
Maria del Pilar Torres
Clinical Operations Manager
PRAHS, Colombia
Learning Objective : Discuss the importance of the global requirements needed in the Informed Consent Process (ICH-GCP); Identify the evolving regulatory requirements and updates; Describe how to conduct effective IC monitoring according to the different country-specific differences in today's environment.
Speaker(s)
Informed Consent: Promise, Pledge, Contract or Platitude?
Michael Swit, JD
Varian, United States
Senior Director, Legal, Regulatory Affairs
CRA's Knowledge and Adaptability Required to Monitor Informed Consent Process in an Evolving Regulatory Environment
Maria del Pilar Torres
PRAHS, Colombia
Clinical Operations Manager
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