CTSI 2025 FDA Symposium
CTSI 2025 FDA Symposium
Adapting to Change: Innovations in FDA-Regulated Clinical Trials
Co-Sponsored by The Ohio State University College of Nursing and Nationwide Children’s Hospital
Symposium Details
Friday, May 9, 2025, 9 a.m. – 4 p.m.
Jane E. Heminger Hall, 1577 Neil Avenue, Columbus, Ohio 43210
The symposium will feature a series of insightful sessions aimed at exploring FDA-regulated research guidelines, discussing the evolving drug and device development regulatory processes and applying quality improvement approaches to enhance inspection readiness in clinical trials. Attendees will gain valuable insights into the latest innovations in FDA-regulated clinical trials, enhance their understanding of regulatory processes and hear from industry experts. A lunch will be provided.
The FDA Conference is open to graduate students, faculty and staff engaged in research or utilizing FDA resources, with no associated registration fees.
Agenda
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Dr. Julie Johnson, PharmD
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Subinoy Das, MD, FACS, U.S. Institute for Advanced Sinus Care and Research
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Grace Maynard-Wentzel, CCRP, CHRC, The Ohio State University
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Jessica Fritter, DHSc, MACPR, ACRP-CP, The Ohio State University
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- 21 CFR 11 – Redcap Black
- Timothy Huerta, PhD, MS, CRIO & Associate Dean for Research Information Technology
- AI Predictive Analytics Model
- Lang Li, PhD, Chair, Biomedical Informatics, Department of Medicine, The Ohio State University
- 21 CFR 11 – Redcap Black
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Lunch and break
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Angel Cinco, MD, MPH, Nationwide Children's Hospital
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Protocol Development- April Green, MACPR, CCRC, The Ohio State University
Protocol Implementation- Kristy Ott, CCRP, Nationwide Children's Hospital
Developing a Recruitment Plan- Lindsay Hanes, BS, CRCC, The Ohio State University
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Break
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FDA Inspections - Moderated Q&A Panel
Preparing for an FDA Inspection: Michelle Bright, MA, CCRP, The Ohio State University
Post Inspection/CAPAs: Jen Zvosec, MCR, CCRP, The Ohio State University
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Carolynn Jones, DNP, MSPH, RN, FAAN, CRN-BC
FDA Symposium Speaker Biosketches