Modern biobanks manage a large number of patient samples and hence pose a risk to patient privacy. Therefore, biobanks need to follow a certain set of regulations and guidelines such as HIPAA, ISO 20387:2018, ISBER & NCI Best Practices, EU GDPR, and 21 CFR Part 11, to ensure that they are legally and ethically competent. Regulatory compliance in biobanks helps protect sensitive health information, establish standard operating protocols, manage access to electronic documents, and define quality management systems, in turn advancing research in healthcare and personalized medicine. All commercial, third-party, or in-house biobanks need to protect patient privacy while meeting regulatory requirements. A good informatics solution, such as a laboratory software for biobanking, can help biobanks meet the governance and compliance requirements, right from managing consent to monitoring SOPs, to maintaining chain of custody and audit trail, to authenticating access to records.
- The importance of regulatory compliance for biobanks
- An overview of major regulatory compliance and best practices for biobanks across the globe
- How informatics help biobanks meet compliance, automate workflows, and follow best practices to stay ahead of the curve
Who Should Watch
Recommended attendees include biobank managers, quality managers, and technicians.