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Webinars

Learn anytime, anywhere with Schulman’s webinars.

Each month, Schulman’s webinar series connects attendees with IRB experts and industry thought leaders to share regulatory insights and best practices.

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  • Convenient web-based format
  • No cost for attendance
  • Robust Q&A with webinar presenter
  • Online archive of all recorded webinars

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Schulman is committed to sharing our experience and expertise with the research community, promoting professional development, discussion and collaboration.

Webinar presentations offer expert content on a variety of IRB-related topics, including industry trends, regulatory details and IRB processes.

Schulman’s webinars are a great way to support existing training programs. Certificates of attendance are available for each live presentation. The webinars may be eligible for continuing education credits—check with your individual certifying organization for more information.

Human Gene Transfer Research and Institutional Biosafety Committees (IBCs): An Introduction

Schulman IRB’s Biosafety Officer Daniel Eisenman discusses the IBC’s role in ensuring research involving genetic engineering is conducted safely and responsibly.

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Federal Initiatives Toward Single IRB Review

Michele Russell-Einhorn, VP of Human Subject Protection Services and Institutional Official at Schulman IRB, discusses recent federal initiatives for single IRB review and their impact on the way sponsors, CROs and institutions conduct research.

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Navigating the Regulatory Requirements of Pediatric Research

Schulman IRB Vice Chair Nathan Lee discusses the specific OHRP and FDA regulations regarding research in pediatric populations and their impact on proposed pediatric research.

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Drug Documents and Device Documents: Definitions and IRB Review

Product Safety Analyst Tricia Henson discusses the drug and device documents that must be submitted to the IRB during initial review and throughout the study.

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In Vitro Diagnostic Device Clinical Trials: Regulation and Review

IRB Member Danielle Macario delves into the various regulatory paths for devices, how those paths impact the regulations devices are subject to, and IRBs review device studies.

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Does the NPRM Get Biospecimens Right? Applying the New Standards to Challenging Ethical Issues

Presenters measure the NPRM’s changes against historical events and personal experiences to determine whether these updates provide improved human subject protections.

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Just Because You Can Measure Everything Doesn’t Mean You Should – Measure What Matters

In this webinar, Eli Alford, COO at Schulman IRB, discusses how to thoughtfully use and report metrics in clinical research.

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It’s Guaranteed Not to Work If You Don’t Use It: Site & IRB Perspectives on Digital/Social Media Recruiting

This webinar explores how IRBs review this type of recruitment material and the basics of using digital and social media in recruiting study participants.

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Adaptive Phase I Studies: The IRB Perspective

In this webinar, IRB member Marilyn Teal reviews why adaptive designs are used and covers areas of special interest when these studies are reviewed by the IRB.

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Oncology Studies from an IRB Perspective

IRB Chair Rebecca Rogers discusses IRB review of oncology studies, paying particular attention to recent innovations in oncology research and how they may impact the IRB’s review.

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Determining the Review Level: Non-Human Subject Research, Exempt or Expedited

Andrea Bidwell, IRB member at Schulman IRB, reviews the regulatory definitions of research, research involving human subjects, exempt research and expedited research.

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eTMF + IRB Integration = Efficiency

TransPerfect Life Sciences, Schulman IRB and Betsy Fallen as they discuss document management challenges of the past, describe current regulatory perspectives, and outline a vision for the future of IRB portal integration with eTMF.

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Establishing a NIH-Funded Central IRB: The NIH StrokeNet Experience

In this webinar, Michael Linke, IRB Chair at the University of Cincinnati, describes the experience of establishing the NIH StrokeNet Central IRB.

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Meeting the Challenge of Device Studies

In this webinar, Robert Romanchuk, IRB Vice Chair at Schulman IRB, discusses the important differences and practical ways to meet the challenges device studies present, meeting the needs of the novice and the expert.

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Evolution of Ethics and Regulation of Research Involving Humans

Ernest Prentice, Institutional Official at the University of Nebraska Medical Center, reviews the evolution of ethics & regulation in human research.

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Expanded Access Part 2

Rebecca Rogers, IRB Chair at Schulman IRB, discusses expanded access for intermediate and large patient populations and early/expanded access of devices.

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Expanded Access Part 1

Rebecca Rogers, IRB Chair at Schulman IRB, discusses expanded access for individual patient use and “Right to Try” legislation.

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Waiver of Informed Consent

Rebecca Ballard, VP Compliance & Board Operations at Schulman IRB, reviews regulatory criteria to waive informed consent and common waiver justifications.

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The Complaint Department

James MacFarlane, HRPP Director, University of New Mexico presents best practices for dealing with complaints, questions and concerns of study participants.

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Humanitarian Use Devices

Robert Romanchuk, IRB Vice Chair, Schulman IRB, presents humanitarian use devices.

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