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We will discuss real-world examples of how IRBs can further improve risk management and quality systems through education of all aspects in clinical trials.
Experts Rebecca Miksad and Tim Stoddard of Flatiron Health provide a practical look at the role of real-world evidence (RWE) in regulatory, drug development, and clinical decision-making.
Ellen Liedel-Sargent and Robert Romanchuk outline key activities that can help prepare a research site for a positive inspection experience.
Judith Carrithers and discuss a checklist of action items to consider and complete prior to the revised Common Rule compliance date.
In this webinar, Luke Gelinas, PhD, IRB Chair at Advarra, lays out some of the oversight challenges raised by PCOR.
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.
Leslie Thornton and Nick Wallace provide an introduction to the GDPR and its potential application to the US-based research community.
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.
Anthony Keyes reviews the federal regulations regarding registration and results reporting of clinical trials.
Robert Neff and Michele Russell-Einhorn discuss considerations and issues research professionals should be aware of when developing research projects that involve mobile apps.