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Wednesday, June 26 • 2:00pm - 3:15pm
#366: Translating Academic Research into Product Development: Integrating GCP Training into the Process (Part 4 of 4)

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-690-L04-P; CME 1.25; IACET 1.25; RN 1.25

As part of a series on GxP, this session describes how approaches to better ensure quality in IITs can lead to more efficient product development. Monitoring/auditing, routine quality functions in industry-trials, are often lacking in IITs.

Learning Objectives

Explain how quality initiatives in investigator-initiated trials (IITs) can lead to more efficient product development; Identify benefits of self-study modules to cross-train clinical trial professionals in essential concepts and practical approaches to monitoring/auditing; Describe the challenges to implementation of monitoring and auditing training programs.

Chair

Eunjoo Pacifici, PharmD, PhD

Speaker

Academic Perspective
Amelia Rose Spinrad, MS

Industry Perspective
Stan Jhee, PharmD

NIH Perspective
Susan E Vogel, BSN, RN


Speakers
SJ

Stan Jhee

Corporate Vice President, Parexel
Dr. Jhee is a clinical pharmacologist with expertise in a wide range of early drug development studies from First-in-Human through Proof-of-concept. His work involves drugs in a variety of therapeutic areas. However, a significant portion of the programs are in Neurology and Psychiatry... Read More →
avatar for Eunjoo Pacifici

Eunjoo Pacifici

Director, International Center for Regulatory Science: Assistant Professor, University of Southern California
Dr. Pacifici worked at Amgen conducting clinical research focusing her efforts initially on managing U.S. investigational sites and central laboratories. She then moved to the Asia Pacific/ Latin America group interfacing with local clinical and regulatory staff in Japan, People’s... Read More →
avatar for Amelia Spinrad

Amelia Spinrad

Regulatory Knowledge Support Administrator, USC International Center For Regulatory Science
Amelia Spinrad, MS is currently a Regulatory Knowledge Support Administrator working at the International Center for Regulatory Science on projects with the Southern California Clinical and Translational Science Institute (SC-CTSI). She manages a regulatory research and her main project... Read More →
SV

Susan Vogel

Clinical Research Oversight Manager, National Institute of Allergy and Infectious Diseases, NIH
Susan Vogel is a Clinical Research Oversight Manager within the Office of Clinical Research Policy and Regulatory Operations (OCRPRO)/ Division of Clinical Research (DCR)/ NIAID/ NIH. Ms. Vogel has 18 years of experience in the clinical trials management environment and has been providing... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Session