Join us to learn how to navigate ethical and regulatory requirements for using human biological specimens in research.
As a researcher or purchaser of Human Biological Specimens (HBS), such as blood, tissue, and other bodily materials, you need to ensure that your HBS are collected according to regulatory oversight and in line with best practices. In this important webinar, BioIVT’s experienced Compliance & Regulatory Affairs (C&RA) team will provide some background on the consequential significance of these guidelines, outline key regulations, and delve into the current landscape.
Modern research emphasizes the importance of informed consent, privacy, and the ethical use of specimens. Researchers must navigate complex regulations to ensure compliance and protect participants’ rights. BioIVT’s experts will discuss how to meet these expectations and detail:
- Informed Consent, Transparency, and Privacy/Confidentiality
- Data Integrity, Data Privacy, and Data Protection
- Onboarding Diligence, Auditing and Monitoring
- Harmonizing and Integrating Regulatory SOPs and Policies
- Regulatory and Ethical Review
- Noncompliance and Deviations
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Presenters
Sr. C&RA Director/DPO
BioIVT
Amanshe joined BioIVT in 2014. Prior to joining BioIVT, she was a Regulatory Coordinator at Central Florida Pulmonary Group. Amanshe has a Bachelor of Science in Business Administration (Health Services Management), Master of Public Administration in Healthcare Management, Graduate Certificate in Human Resources Management from DeVry University and Devry’s Keller Graduate School of Management, and is currently pursuing a Graduate Certificate in Regulatory Affairs at George Washington University. Her focus is on improving process, integrations, data privacy and supporting the C&RA team and BioIVT’s growth.
Sr. C&RA Manager
BioIVT
Latea joined BioIVT in 2016. Prior to joining BioIVT, she supported clinical trials at Memorial Sloan Kettering and the regulatory functions at a dental medical device company. Latea has a Bachelor of Science in Health Services Management from East Carolina University and Master of Science in Regulatory Affairs from Northeastern University. Her focus is on enhancing and improving the global regulatory process at BioIVT and supporting customer needs.
Global Auditor
BioIVT
Reshana joined BioIVT in September 2022. Prior to joining BioIVT, she spent time at Northwell Health and Mount Sinai Hospital in New York supporting clinical trials and co-published a report which contributed to the advancement of pediatric research in NYC. Reshana has a Bachelor of Science in Health Sciences from Hofstra University and a Master of Public Health in Health Policy and Management from NYU. Her primary focus is on supplier qualification and compliance with the intention of harmonizing audit processes across BioIVT.
Sr. C&RA Manager
BioIVT
Tracy joined BioIVT with the acquisition of Asterand in 2017. Prior to Asterand, she was a QA Auditor and Regulatory Manager at the University of Florida. Tracy is a Certified Cancer Registrar and her experience in clinical research spans 30+ years. Her current focus is disease state biospecimens.
C&RA Manager
BioIVT
Stephanie Shipley joined BioIVT with the acquisition of PPA and Keystone in 2019. Prior to PPA, she was a Clinical Research Coordinator at PMG Research (now Accellacare) and coordinated many clinical trials in a variety of therapeutic areas with Tennessee Oncology, Gray Family Healthcare and Arthritis Assoc. of Kingsport. She has a Bachelor of Science in Applied Human Science and a Master of Science in Clinical Nutrition from ETSU. Her focus is on BioIVT’s BSC and CTLS donor center network.
Sr. C&RA Manager
BioIVT
Tracy joined BioIVT with the acquisition of PrecisionMed (PM) in 2023. She spent 22 years enhancing and developing various areas within PM and provided regulatory support at UCSD Moores Cancer Center. Prior to PM, Tracy spent 2 years at Radiant Research supporting donor recruitment efforts for drug trials and advanced to regulatory affairs. She graduated from community college, completed GCP & GMP certification programs and is continuing her education at UCSD in Regulatory Affairs for Drugs & Biologics. Her current focus is on C&RA as a part of our global team.
Production Partner
BioIVT
BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to life science and diagnostic industries. Recognized as an industry leader, BioIVT specializes in control and disease state samples including human and animal tissues or preparations, ADME-Tox products and research services, cell and gene therapy products, blood, and other biofluids.
By combining technical expertise and exceptional customer service with unmatched access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®.
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