Regulatory Science Symposium: “Keys to a Clinical Trial: Management and Operations” Session 1 - Welcome (2024)

Regulatory & Quality Sciences
Study & Site Management
Eunjoo Pacifici, PharmD, PhD

Chair and Associate Professor of Regulatory and Quality Sciences Associate Director, D. K. Kim International Center for Regulatory Science

Competencies: Pharmacy, Regulatory Science, Clinical Trial Quality, Clinical Research and Regulations, Project Management, Clinical Trials, Regulatory and Quality Sciences, Clinical Trial Workforce

Course Syllabus/Topics:
1. Introduction

  • A big welcome to in-person attendees from industry and academia, and online attendees from MPTX classes!
  • Index cards available for questions for speakers or panelists.
  • E-Binder available online.

2. SC CTSI Clinical Research Support (CRS)

  • A single stop aiding investigators and research teams to develop, activate, conduct, and report results for human subject research studies.
  • Contact information: crs@sc-ctsi.org

3. Clinical Trial Quality Training Series:

  • Created by the USC Department of Regulatory and Quality Sciences and Regulatory and Knowledge Support (RKS) core within SC CTSI
  • Free, open-access resources for clinical research professions.
  • Purpose of modules: to cross train investigators in the practices clinical trial quality
  • Enroll for free: http://uscregsci.remote-learner.net.

4. Georgia CTSA and SC CTSI: Online Course Catalog

5. Regulatory Knowledge & Support Web Portal

  • A one-stop shop of regulatory resources available.

6. For more information about the USC Regulatory and Quality Sciences, see: http://regulatory.usc.edu

7. Degree Programs

  • Six Graduate Streams DRSC, MS Regulatory Science, MS Management for Drug Development, and MS Medical Product Quality, M.S. Clinical Trial Management (COMING Fall 2024!!)
  • Certificates: Food Safety, Regulatory Science, Early Drug Development, Clinical Design and Management, Patient and Product Safety

8. Symposiums

  • Occurring since 2015!
  • Symposium recordings are easily accessible for viewing on the SC CTSI’s online educational library: https://sc-ctsi.org/training-e...
  • Topics for future symposia are from your feedback

9. Agenda

  • Today’s symposium topic: Keys to a Clinical Trial: Management and Operations

10. Program Evaluation

  • Please complete the evaluation at the end of the symposium to receive your certificate.

Acknowledgements
Accompanying text created by:
Roxy Terteryan | RKS Project Administrator, SC CTSI (atertery@usc.edu)
Nikhita Datar | Student Worker