President & CEO
Global Strategic Solutions, LLC
David R Rutledge, Pharm.D., FCCP, FAHA is an accomplished and results-oriented consultant for clinical evaluations and investigations, clinical risk management, regulatory, and quality. He brings 25 years’ global experience with agencies such as US FDA, Brazil ANVISA, Mexico COFEPRIS, NMPA (China FDA), S Korea Ministry of Food and Drug Safety, Hong Kong, Malaysia, Health Canada, Australia TGA, Thailand FDA, Japan PMDA, EMA, Saudi FDA, CDSCO of India and several Notified Bodies, e.g., BSI, DEKRA, Medcert, and TÜV SÜD. As a former tenured Professor/Chairman in academia, IRB member and clinical investigator, he understands the role of a PI as a sponsor-investigator in clinical trials. He has published over 100 manuscripts. He was inducted as a Fellow of the American Heart Association in 1995. He previously accepted a 4-year appointment from the United States Department of Health & Human Services to serve as the Industry Representative on the FDA’s General Hospital and Personal Use Devices Advisory Committee in FDA’s Center for Devices and Radiological Health (CDRH). He is certified as a Lead Auditor for Quality Management Systems ISO13485 and holds Design Control, Risk Management, Six Sigma, and CAPA certificates. Dr. David R Rutledge was formerly a Director with Abbott Medical Devices in Global Clinical Research and then Global Regulatory Operations. He has managed budgets up to $23.3 million. He is currently President & CEO at Global Strategic Solutions, LLC within the Biotech, Med Device, and Pharma industries in the areas of Clinical Investigations, Clinical Evaluations, Clinical Risk Management, Surveys, PMS/PMCF, SSCP, PSUR, R&D, Meta-Analyses, Big Data, Artificial Intelligence, and Biocompatibility. Person Responsible for Regulatory Compliance (PRRC).
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Sunday, September 11, 2022
8:30 AM – 4:00 PM MST