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
Loved ones coming together is what the holidays are all about, but first you have to get there. This holiday season is expected to receive more travel on the roads than in previous years due to the…Continue
ISQEM are pleased to announce the ISQEM Safety Conference USA in June 2013, Location: Las VegasThe conference will be one of the leading events of the year, which will allow delegates to meet a range…Continue
We have been throwing around the idea of incorporating more incentives for individual or work groups with zero incidents. Does anyone have any experience with this positive or negative? Does anyone…Continue
Started by Trinity. Last reply by Lyndon Pousson Mar 9, 2011.