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.
Agenda
-
Dr. Julie Johnson, PharmD
-
Clinical Trial Innovation and GCP- Captain Kavita Dada, PharmD, RAC, U.S. Food and Drug Administration
-
Grace Maynard-Wentzel, CCRP, CHRC, The Ohio State University
-
Jessica Fritter, DHSc, MACPR, ACRP-CP, The Ohio State University
-
Subinoy Das, MD, FACS, U.S. Institute for Advanced Sinus Care and Research
-
Lunch and break
-
Angel Cinco, MD, MPH, Nationwide Children's Hospital
-
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
Q&A Panel moderated by Carolynn Jones, DNP, MSPH, RN, FAAN, CRN-BC
-
Break
-
Preparing for an Inspection- TBA
Post Inspection/CAPAs- Jen Zvosec, MCR, CCRP, The Ohio State University
Ends with a Q&A
-
Carolynn Jones, DNP, MSPH, RN, FAAN, CRN-BC