Exploring Series

Exploring the Common Rule: A Guide For Beginners

Exploring the Common Rule: A Guide For Beginners

New to IRB administration? Does the Common Rule seem daunting? If so, this workshop is for you!  

Offered in three 2-hour sessions, it will provide you with a road map to navigate key sections of the Common Rule, and set you on the path to a successful career in IRB administration.  
 

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Exploring the IRB Administrator’s Role in the Life of a Protocol

Exploring the IRB Administrator’s Role in the Life of a Protocol

This workshop is designed for both new IRB administrators as well as a refresher for those with more experience. The workshop examines the roles and responsibilities of an IRB administrator from the receipt of a new protocol to study close out.  

Offered in three 2-hour sessions, with intersession Learning Labs this workshop will provide an opportunity to delve deeper into various topics and issues that IRB administrators face in their day-to-day work. 

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Exploring FDA Regulations

Exploring FDA Regulations

This introductory-level workshop is designed for those involved in the study or oversight of drugs, biologics, and devices regulated by the Food and Drug Administration (FDA).  

Offered in three 2-hour sessions, through pre-learning modules and interactive exercises, the workshop will equip attends to gain proficiency in applying the FDA regulations.  

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Exploring FDA Regulations: Navigating the Nuances of FDA-Regulated Research

Exploring FDA Regulations: Navigating the Nuances of FDA-Regulated Research

This advanced-level, three-session workshop is designed for research compliance professionals, regulatory affairs professionals, clinical research coordinators, and others involved in the study, oversight, and regulation of drugs, biologics, and devices.

Through interactive exercises, immersive case studies, and expert-led presentations, you will gain proficiency applying the FDA regulatory framework to advanced scenarios.

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