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.
Martha Hernández Scientist, CloudLIMS.com
Martha is a chemist with expertise in diverse areas of analytical chemistry. She had worked as an analyst at a licensed 3rd party analytical laboratory where she focused on developing and validating analytical methods for bioequivalence studies. Later, she served as a quality control expert in the analytical domain and as a monitor in clinical trials. Her interest in the clinical industry led her to be a part of two of the biggest hospitals in Mexico where she gained expertise in hematology, microbiology, and blood banking. Later, she became a member of the team of forensic chemical experts and started working from day one as a specialist in narcotics and drugs. This enabled her to gain rich experience in GC-MS, FTIR, HPLC-MS/MS, ICP-MS, and other analytical techniques for the separation, detection, and quantification of different molecules such as cannabinoids. She had participated in multiple oral trials defending her legal opinions and worked as an expert consultant. She had worked on the synthesis of small molecules for testing them on multi-drug resistant bacteria and mycobacteria, further developing her analytical skills in column chromatography, thin-layer chromatography, microbiology, and compound elucidation by NMR and HRMS. She carried out a research stay at the University of Barcelona with the organic synthesis team. She had also worked on natural products in France and presented her work at conferences in the USA and France. She received awards and accolades for her exceptional work. She has participated in several conferences as a moderator as well.Martha holds a bachelor’s degree in Clinical Chemistry from the Faculty of Medicine UANL and a master’s degree in Pharmacy from the Faculty of Chemical Sciences UANL, Mexico.