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.
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: