Webinar
Preparing for and Responding to an FDA Inspection
Ellen Liedel-Sargent and Robert Romanchuk outline key activities that can help prepare a research site for a positive inspection experience.
Making a List, Checking It Twice… The Revised Common Rule Is Coming to Town!
Judith Carrithers and discuss a checklist of action items to consider and complete prior to the revised Common Rule compliance date.
Oversight Challenges with Patient Centered Outcomes Research
In this webinar, Luke Gelinas, PhD, IRB Chair at Advarra, lays out some of the oversight challenges raised by PCOR.
An Introduction to Human Gene Transfer Research and Institutional Biosafety Committees (IBCs)
Daniel Eisenman discusses the basics of research involving genetic engineering and the role played by the IBC in ensuring research is conducted safely and responsibly.
The EU General Data Protection Regulation: Implications for Research
Leslie Thornton and Nick Wallace provide an introduction to the GDPR and its potential application to the US-based research community.
Expanded Access and Right to Try: The Impact of Recent Legislative Changes
This webinar provides an overview of the current state of the FDA’s Expanded Access Program and state and federal “Right to Try” legislative efforts.
Navigating the Expanding Regulations of ClinicalTrials.gov Registration and Results Reporting
Anthony Keyes reviews the federal regulations regarding registration and results reporting of clinical trials.
Mobile Apps: Considerations for Use in Research Involving Human Subjects
Robert Neff and Michele Russell-Einhorn discuss considerations and issues research professionals should be aware of when developing research projects that involve mobile apps.
Lessons from the Trenches: Avoiding Common Legal Pitfalls in International Research
Emily Chi Fogler and Andrew Rusczek, attorneys practicing at Verrill Dana, LLP, discuss common legal issues for institutions and companies participating in international research.