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Translating Academic Research into Product Development: The Importance of Understanding GLPs at an Early Stage (Part 3 of 4)
Session Chair(s)
Isabel Lauren Jackson, PhD
Associate Professor
University of Maryland School of Medicine, United States
As part of a series on GxP, this session will describe GLP requirements for successful translation of academic research projects. GLP requirements for toxicity studies must be met before FDA allows new therapies to proceed to human clinical trials.
Learning Objective : Describe the characteristics GLPs; Recognize where GLP fits in the development cycle of a medical products being developed in academia; Identify how GLPs in academia can help to translate innovate therapies into products more efficiently.
Speaker(s)
An Introduction to Good Laboratory Practice (GLP) Regulations: What Are They, and How Did We Get Here?
Jon Carl Mirsalis, PhD, MS
SRI Biosciences, United States
Vice President, Translational Development
Translating Academic Research into Product Development: Implementation of a Quality Management System in Academic Laboratories to Improve Data Quality, Traceability, and Reproducibility.
Isabel Lauren Jackson, PhD
University of Maryland School of Medicine, United States
Associate Professor
Translating Drug Discovery From Academia and Important Criteria for Success
Andrew Norris, PhD
BCN Biosciences, United States
Director of Research
Perception Versus Experience: The Advantages of Academic Research and Development Partners and Limitation of Commercial CRO's
John L McManus
EVS Partners, United States
Principal
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