Sponsor’s Role in Regulatory Testing — A Conversation with Lara Hall
This week, I welcomed to the studio Lara Hall, Senior Regulatory Scientist/Quality Assurance Specialist at B&C and our consulting affiliate, The Acta Group, to discuss the critical importance of understanding the role of the study sponsor. As our listeners know, chemical data -- testing results, chemical studies, exposure information, environmental fate and monitoring data, to name a few -- are the new currency in the chemical community. These data are incredibly valuable, often proprietary, and increasingly used both to support chemical applications and to rebut allegations of adverse consequences resulting from chemical exposure. How these data are developed, who serves as study sponsor, how the sponsor interacts with the study monitor, laboratory, and others are significant issues and subject to Good Laboratory Practice (GLP) standards. Lara and I discuss GLP and the rights, duties, and obligations of all the actors involved in chemical testing and offer some tips and insights in managing this increasingly complicated space. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2024 Bergeson & Campbell, P.C. All Rights Reserved