Original Air Date: Thursday, August 12, 2010 at 1pm EST
Presented by:
Gladys Dubourg, Senior Quality Assurance and Compliance Manager, Clinilabs, Inc.
Howard Greenberg, MD, MSE, MBA, FCP,
Senior Medical Director, Clinilabs, Inc.
To view the recording Click Here
This lecture offers a discussion on how to build risk management into clinical trials in today's competitive environment.
This presentation is intended to offer a process by which risks can be identified, assessed and mitigated during the conduct of clinical trials
Gladys Dubourg
Gladys
has over twelve years of experience working in the pharmaceutical industry. Her primary area of expertise is Quality Assurance and Regulatory Compliance. She has worked with both local and foreign regulatory agencies.
Gladys is currently the Senior Quality Assurance & Compliance Manager at Clinilabs. She is responsible for managing Clinilabs quality systems and ensuring that the company operates in compliance with current Good Clinical Practices (cGCP) regulations.
Prior to joining Clinilabs, Gladys Dubourg was Manager of Global Clinical Policies and Procedures within R&D Operations, a division of Bristol Myers Squibb. She holds a Masters of Science in Quality Management from California State University.
Howard Greenberg, MD, MSE, MBA, FCP
Dr. Greenberg has extensive experience in clinical pharmacology research. Over the past twelve years, he has served as the Principal Investigator or Co-Investigator for more than 100 clinical trials. He has co-authored more than 30 peer-reviewed research publications and currently serves on the editorial boards of Therapeutics and Clinical Risk Management and the Journal of Clinical Pharmacology.
Dr. Greenberg received a BS degree in Chemical Engineering from Cornell University and a MSE degree in Chemical Engineering from the University of Pennsylvania. He received a Master of Business Administration degree in Finance and Planning from Drexel University and Doctor of Medicine degree from Jefferson Medical College. Dr. Greenberg is board certified in Internal Medicine and Clinical Pharmacology. He completed his training in Internal Medicine at Lankenau Hospital and Clinical Pharmacology at Thomas Jefferson University Hospital in Pennsylvania. He currently serves on the Board of Regents of the American College of Clinical Pharmacology (ACCP), and is the President-elect of the Association of Clinical Pharmacology Units (ACPU).
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