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
Thank You For Attending!
Thank you to everyone who participated in the 2025 CTSI FDA Symposium! This year’s event offered a range of insightful sessions, focusing on FDA-regulated research guidelines, evolving regulatory processes and practical strategies to improve inspection preparedness through quality initiatives in clinical trials.
Keynote speaker, Dr. Subinoy Das, MD, FACS, Chief Executive Officer for the U.S. Institute for Advanced Sinus Care and Research, presented an exceptional keynote session, sharing invaluable insights about working with the FDA and providing a behind-the-scenes glimpse into the complexities of medical device development. His expertise delivered a uniquely engaging and informative perspective.
Attendees also had the opportunity to explore diverse topics through specialized sessions, including:
- Decentralized clinical trials
- Revisions to ICH E6 (R3)
- REDCap Black
- Artificial intelligence predictive analytics models
- Drug development protocols
- Strategies for developing effective recruitment plans
In addition to the educational content, the symposium served as a valuable networking platform, enabling participants to connect with peers and industry leaders to share ideas and best practices.
Thank you to our co-sponsors, The Ohio State University College of Nursing and Nationwide Children's Hospital, for their support in making this event possible.
And we thank all attendees, speakers and organizers for their contributions to making the symposium an enlightening and successful event. We are excited to continue fostering collaboration and learning in future programs.
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