Wes, welcome to the Safety Community. I hope you will find the Safety Community to be a tremendous resource to meet your goals. If you have the time, we would benefit from your knowledge and experience with Forum discussion(s).
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
What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue
Workers paticipation in safety management is the aspect which is required to be implemented in the OHSAS 18001 2007 version. , I invite our experience community members to share their views on the…Continue
How to improve safety culture of factories having mostly contract and casual ever changing workers for whom training and monitoring both are major issues. Such qorkers are mainly meeting accidents in…Continue
Started by Harkant Dave. Last reply by Jen McDade Dec 24, 2018.
I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their…Continue