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.…
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…
Luke Gelinas, PhD, IRB Chair at Advarra, discusses some of the oversight challenges presented by PCOR and shares policy recommendations for managing such challenges.
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.
In this webinar, presenters from Ropes & Gray LLP provide an introduction to the GDPR and its potential application to the US-based research community.
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.
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.
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…
Emily Chi Fogler and Andrew Rusczek, attorneys practicing at Verrill Dana, LLP, discuss common legal issues for institutions and companies participating in international research.
Robert Romanchuk, IRB Vice Chair at Schulman IRB, reviews the landscape of investigator-initiated research with a focus on the IRB’s perspective.