SQA Webinar: The Evolving Role of Sponsors in GLP Studies: Oversight and Regulatory Expectations
This online webinar will be given via Zoom.
Presented by: Anand Pandya, Microcrispr Pvt. Ltd.
Webinar Category: Compliance
Regulatory Area of Interest: GLP
Description: Sponsors play a vital role in ensuring that Good Laboratory Practice (GLP) studies are conducted with scientific integrity, regulatory compliance, and data reliability. While sponsors are responsible for selecting qualified test facilities, approving study protocols, and providing adequately characterized test items, they must also ensure that their involvement does not influence study outcomes or compromise independent scientific judgment. Regulatory authorities and OECD guidance emphasize the importance of transparency, proper documentation, and maintaining the independence of the Study Director and Quality Assurance Unit throughout the study lifecycle.
This presentation discusses the key roles and responsibilities of sponsors in GLP studies, including oversight of outsourced activities, communication practices, protocol management, and data integrity expectations. It further highlights regulatory concerns related to inappropriate sponsor influence and outlines practical measures to ensure unbiased study conduct, credible reporting, and regulatory acceptability. The session aims to strengthen awareness of ethical and compliant sponsor involvement within modern GLP environments.
RQAP Re-registration units approved: 1 GLP | non-GCP | non-GMP