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
A member of my association is putting together a safety manual for his new employer and would appreciate it if anyone has a Fire Prevention safety manual section or program that they would be willing…Continue
Started by Cory Zielke. Last reply by Jen McDade Oct 12, 2018.
Can you have an inside storage room for flammable and combustible liquids that is greater than 500 square feet? Of course with an adequate fire suppression system, explosion-proof fixtures and…Continue
Where does everyone go for up-to-date workplace fire statistics - injuries, damage costs, etc. Is there a particular site you like or do you just wait for National Safety Council's annual report?Continue
Started by Michelle Sears. Last reply by Kevin Moore Aug 14, 2012.
I have a question regarding UL testing procedures used to rate dry chemical extinguishers. What testing protocols does Underwriters Laboratory use to determine portable dry chemical extinguisher…Continue
Started by Paul Moore. Last reply by Paul Moore Apr 23, 2009.
It is my understanding that when pressurized cylinders are placed or used on a cart having a bottom lip around the base where the cylinder sits, this lip qualifies as one of the two securing points.…Continue