Webinars
View previously recorded webinars hosted by BRANY. Access expert insights and best practices in regulatory compliance, research operations, and ethical oversight.
FDA Guidance on Safety Reporting: Key Changes and Takeaways
Sponsors, CROs, investigators and site teams, IRB professionals, and regulatory compliance teams will benefit from this webinar that aims to provide clarity around the FDA’s recent guidance about Safety Reporting.
Attendees will learn what safety information must be reported and to whom, what this guidance means for IRB review and oversight, how “unanticipated problems” are defined and applied, and practical sponsor workflows for determining what events are IND Safety Reports.
SPeakerS
Raffaella Hart, MS, CIP
Sr. Vice President, IRB, IBC, and QA
Lauren Hartsmith, JD, CIP
Senior Vice President, IRB, IBC, and QA
Staying Audit-Ready:
Practical Compliance Insights for Clinical Research Sites
Learn a unique, auditor’s perspective into common compliance issues and non-compliance findings in clinical research, specifically in the evolving landscape of Single Institutional Review Board (sIRB) studies. Through an auditor’s lens, attendees will learn how to strengthen their site’s awareness of key compliance aspects for more effective regulatory audit preparation and overall compliance efforts in the sIRB world.
SPeaker
Leah B. Persky, MS, CCRC
Clinical Research Compliance Auditor, BRANY
Ensuring Compliance in Gene Therapy Trials for Neurological Disorders: IRB and IBC Perspective
Gain a deeper understanding of how to ethically navigate gene therapy trials for neurological disorders, the regulatory challenges involved, the collaborative roles of the IRB and IBC, and best practices for consent capacity and legally authorized representatives.
SPeakerS
Raffaella Hart, MS, CIP
Senior Vice President, IRB, IBC, and QA
Linda Reuter, MS, CIP
Sr. IRB Director, BRANY
Venessa Rodriguez, CIP
IRB and IBC Superviser, BRANY
Thos Cochrane, MD, MBA
Director, Fellowship in Bioethics, Harvard Medical School
