The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).The Final Rule has been in effect since January 18, 2017. The International Committee of Medical Journal Editors (ICMJE) requires trial…See More
The aim of this webinar is to provide an introductory overview of the requirements demanded by the FDA and EMA (arguably the two most important regulatory authorities for drug developers) for EIM (the IND and IMPD) and to provide an brief review of where the agencies differ as well the commonalities of approach for their EIM dossiers.Although each regulatory authority publishes guidelines and instructions regarding the requirements for the Entry Into Man (EIM) of a new medication, such…See More
Nebosh is a UK approved educational board which provides various safety courses for working professional and students to become a health and safety ecperts. Nebosh offers safety courses through…Continue
Does anyone know of a good video that covers all of the focus four topics? I've checked with Coastal and Wumbus and so far I've found nothing. One of my clients wants a single video to cover all…Continue
Started by Wes Daubenspeck. Last reply by John Padilla Jun 4, 2012.