'Drug device' presentation slideshows

Investigational New Drug (IND) Orientation Responsibilities of IND Sponsor-Investigators

Investigational New Drug (IND) Orientation Responsibilities of IND Sponsor-Investigators. MICHR IND/IDE Assistance Program (MIAP). Definitions.

940 views • 46 slides

IRB Cheat Sheet: Tips and Tools for keeping our study organized and regulatory compliant

Alyssa Speier, MS, CIP November 13, 2013. IRB Cheat Sheet: Tips and Tools for keeping our study organized and regulatory compliant. qip@hsph.harvard.edu www.hsph.harvard.edu/ohra/qip. Agenda. ICH-GCP Guidelines QIP Regulatory Binder Review of Contents/Sections Participant Files

228 views • 22 slides

Adverse Event Reporting for Combination Products Bradley Merrill Thompson Leighton Hansel Colleen Hittle

151 views • 7 slides