E8(R1) General Considerations in Clinical Trials

Event Organization
Clinical Trials BC

Hosted by Jean Smart

Attend this 1.5-hour presentation to brush up on the changes to this core ICH document, which is the foundation of the ICH efficacy group.

Learning Objectives
The learner will be able to:

• Describe internationally agreed-upon principles and practices to facilitate regulatory acceptance.

• Understand the elements of quality that are considered in the design and conduct of clinical studies, including:
-Identification of factors critical to the quality of the study.
-Management of risks to those factors during study conduct.

• Identify the types of clinical studies performed during the product lifecycle.

• Be Familiar with the ICH Efficacy Family of Guidelines.

More details about the educational sessions on ICH E8(R1) document's topics:

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