Preparing for and Responding to an FDA Inspection
Robert Romanchuk, IRB Chair at Advarra, and Ellen Liedel-Sargent, Senior Director of Consulting at Advarra, 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, JD, Director of Regulatory Services at Advarra, and Michele Russell-Einhorn, JD, Chief Compliance Officer and Institutional Official at Advarra, discuss a checklist of action items to consider and…
Oversight Challenges with Patient Centered Outcomes Research
Luke Gelinas, PhD, IRB Chair at Advarra, discusses some of the oversight challenges presented by PCOR and shares policy recommendations for managing such challenges.
An Introduction to Human Gene Transfer Research and Institutional Biosafety Committees (IBCs)
Advarra’s Director of Biosafety Services Daniel Eisenman discusses the basics of research involving genetic engineering and the role played by the IBC in conducting safe and responsible research.
The EU General Data Protection Regulation: Implications for Research
In this webinar, presenters from Ropes & Gray LLP 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
Presenters from Advarra and Verrill Dana, LLP, provide 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, Program Manager at the Johns Hopkins University School of Medicine ClinicalTrials.gov Program, reviews the federal regulations regarding registration and results reporting of clinical trials.
Mobile Apps: Considerations for Use in Research Involving Human Subjects
Robert Neff, Director of Innovative Technology Solutions at Thomas Jefferson University, and Michele Russell-Einhorn, Chief Compliance Officer and Institutional Official at Advarra, discuss considerations and issues research professionals should be…
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.
IRB Considerations for Investigator-Initiated Research
Robert Romanchuk, IRB Vice Chair at Schulman IRB, reviews the landscape of investigator-initiated research with a focus on the IRB’s perspective.