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MEDTECH SUMMIT STARTS IN

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18 - 22 October 2021
Virtual EventDelivered in CEST time zone

David Rutledge
President & CEO, at Global Strategic Solutions

Profile

David R Rutledge, Pharm.D., FCCP, FAHA is an accomplished and results-oriented global consultant for clinical evaluations, clinical risk management, regulatory, quality, and clinical investigations. He brings 25 years’ experience and exceptional knowledge in product-level analysis, clinical protocol and eCRF development, scientific data analysis, organizational design, integration of science with business needs, quality management systems, signal detection, global clinical evaluations, clinical risk management, and regulatory affairs. He has direct experience developing and leading international regulatory presentations, submissions, and reports to 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, UK MHRA, and several Notified Bodies, e.g., BSI, DEKRA, GMED, MEDCERT, NSAI, and TÜV SÜD. He has participated in the FDA COVID-19 Emergency Use Authorization program.

He has management and professional experience in both pharmaceutical and device program teams involving products within the cardiovascular, gastrointestinal, respiratory, and AIDS therapeutic areas. 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. Dr. Rutledge served on two FDA panels which led to publishing a device-drug combination Guidance Document on Coronary Drug-Eluting Stents (March 2008). He was a speaker for FDA’s Post-Approval Studies for Medical Devices Workshop (June 2009) and then served as a panel member for the Methodologies for Post-Approval Studies of Medical Devices Workshop (September 2009). In 2010, he 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 also served on the June 27th, 2013, Gastroenterology-Urology Devices Panel of CDRH. He is certified as a Lead Auditor for Quality Management Systems ISO13485 and holds certificates for Design Control, Risk Management, Abbott Compliance Development Program, Abbott Guest Auditor, and 21CRF820 Quality Systems. He is Six Sigma, and CAPA certified. Dr. David R Rutledge was formerly a Director with Abbott Medical Devices in Global Clinical Research and Global Regulatory Operations, where he managed budgets up to $23.3 million. He is currently President & CEO (Founding Partner) at Global Strategic Solutions, LLC within the Biotech, Med Device, Clin Evaluations, Clinical Risk, PMS/PMCF, R&D, Clinical Trialist, and Biologic Compatibility within the Global Clinical, Regulatory, and Quality areas. Qualified as a Person Responsible for Regulatory Compliance; inducted into TEAM-PPRC as an active member 23MAR2021

Agenda Sessions

  • Best Practices for Creating a Compliant Periodic Safety Update Report (PSUR)

    15:50