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

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.