Register now to join Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) for “Sponsor’s Role in Regulatory Testing — Complying with GLP Standards,” a complimentary webinar covering the roles and responsibilities of Study Sponsors, as defined by Good Laboratory Practices (GLP) regulations and related advisory documents, to ensure that non-clinical health and environmental safety studies are conducted in compliance with GLP. This webinar will focus on the GLP requirements that are specifically or implicitly assigned to Study Sponsors and will provide an overview of activities and considerations within this role that are critical to the development of compliant data. The presenters will additionally highlight similarities and differences between U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and Organisation for Economic Co-operation and Development (OECD) GLP regulations as they relate to Study Sponsors’ roles and responsibilities in GLP compliant testing to support global regulatory objectives.
Topics Covered:
- Background of GLP Standards — What is the benefit of GLP compliance?
- GLP requirements for Sponsors — Where does the Sponsor fit into GLP?
- Critical Sponsor activities — Do’s and Don’ts during study conduct.
- Key considerations for ensuring compliance and assuring data quality enforcement risks and effects of non-compliance — Are your studies inspection ready?
Speakers include:
Lara A. Hall, MS, RQAP-GLP, is a Senior Regulatory Scientist and Quality Assurance Specialist at B&C and Acta, and a Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP) with over two decades of experience in environmental research, study monitoring, quality assurance, and international regulatory support. Ms. Hall assists clients in placing and monitoring studies to assist with registration of new chemicals, pesticides, and biocides; developing test plans for chemicals that are subject to regulatory approval; and assessing studies for conformance with testing guidelines, data compensation, and regulatory and GLP requirements.
Michelle C. Mims, MS, RQAP-GLP, is a Regulatory Scientist and Quality Assurance Specialist at B&C and Acta. Ms. Mims assists clients in placing and monitoring studies for regulatory submissions related to new substance registrations and continued compliance under EPA, FDA, and OECD chemical control frameworks.
Lynn L. Bergeson, Managing Partner, B&C, and President, Acta, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.