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 objectives of the symposium are:
- Explore FDA-regulated research guidelines.
- Discuss the evolving drug and device development regulatory processes to improve clinical translational science and reduce barriers in clinical trials.
- Apply a quality improvement approach to improve inspection readiness in clinical trials.
Registration will open soon.
Agenda
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Dr. Julie Johnson, PharmD
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Clinical Trial Innovation and GCP- Captain Kavita Dada, PharmD, RAC, Associate Director for Regulatory Operations with the FDA Center for Drug Evaluation and Research
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Grace Maynard-Wentzel, CCRP, CHRC
Deputy Director, Operations
State of Ohio Adversity & Resilience Study (SOAR)
Department of Psychiatry and Behavioral Health
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Jessica Fritter, DHSc, MACPR, ACRP-CP
Clinical Assistant Professor of Practice
Master of Clinical Research and Undergraduate Clinical Trials Sciences Certificate, College of Nursing
Workforce Development, Clinical and Translational Science Institute
Chapter President, ACRP Ohio Chapter
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Subinoy Das, MD, FACS
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Lunch and break
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Kevin Bosse, PhD, RAC-US, CABP(H)
Director of Regulatory Affairs at Nationwide Children's Hospital
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Protocol Development- April Green, MACPR, CCRC
Protocol Implementation- Sam Eldersveld, CCRP
Holistic Recruitment- Joshua Joseph, MD, MPH, FAHA
Q&A Panel moderated by Carolynn Jones, DNP, MSPH, RN, FAAN
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Break
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Preparing for an Inspection- Michelle Bright, MA, CCRP
Post Inspection/CAPAs- Jen Zvosec, CCRP
Ends with a Q&A
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Carolynn Jones, DNP, MSPH, RN, FAAN