1/24/2017

The ICH GCP draft is has now been updated and finalized by ICH. Let’s discuss the final content and major implications, how to determine next steps. The update helps end the debate related to many best practices. This impacts sites a great deal and the oversight by sponsor/CROs. Then what about the IRB? We will be having a variety of sessions for discussion, training and action planning. To access the guidance, visit the ICH website: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf

Next session: http://preview.tinyurl.com/hj6oaoj

Date: January 25, 2017

Time: 12pm - 1:00pm EST US

Duration: 60 Minutes - Online

Presenter: SAM Sather