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Description: Is the FDA about to name you their fraud police? A proposed new rule will require sponsors to report data falsifications … without any proof … without a possible motive … and even if there’s only a suspicion of fraud. The FDA sent shockwaves through the industry on Feb. 19 when it announced a proposed rule called “Reporting Information Regarding Falsification of Data.” The rule will require sponsors to report any information that indicates that a person has, or may have, engaged in the falsification of data involving clinical investigations, nonclinical laboratory studies and clinical studies in animals. What exactly is going on here? Is the FDA trying to turn sponsors into detective, judge and jury? Learn more about this controversial proposal in this presentation.
Description: Regulatory specialist Gina Ross shows how to create a content development and organization strategy for developing electronic Common Technical Documents and how to develop authoring SOPs that ensure global compliance. Ross discusses:
How to train staff to write eCTDs;
Managing the document throughout its lifecycle; and
The decision-making process for most effective integration of regulatory strategies and eCTD lifecycle management
Description: Dietary supplements expert Ivan Wasserman discusses how FDA adverse event reporting rules apply to OTCs and supplements just as they do to prescription drugs and explains all facets of the reporting process, including:
Description: Clinical trial specialist Charles Pierce educates research facilities and investigators on how to identify and report on adverse events that occur in their trials and make sure they comply with FDA’s and other authorities’ requirements. Pierce covers:
Definitions and types of adverse events;
Monitoring and reporting adverse events and managing risk; and