
FDA regulatory expert Jim O’Reilly discusses how the FDA plans to implement the variety of provisions in the 21st Century Cures Act and how those plans will affect manufacturers. He covers:
Speaker: Jim O’Reilly, Professor, University of Cincinnati College of Medicine
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European regulatory expert James Pink provides a deep dive into the new EU medical device regulations, including its 22 articles on clinical evaluation and investigation. He discusses:
Speaker: James Pink, Vice President, NSF Health Sciences Medical Devices, Europe
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Informed consent expert Susan Brink discusses strategies for implementing an electronic informed consent system. Topics include:
Speaker: Susan G. Brink, Executive Vice President, e-consent Products and Services, Enforme Interactive, Inc.
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Patient recruitment experts David Borasky and Amanda Plucinak present strategies for expediting study recruitment. They discuss:
Speakers: David Borasky, Vice President, IRB Compliance, WIRB-Copernicus Group; Amanda Plucinak, Quality Assurance Manager, ThreeWire
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Supply chain analyst Hedley Rees advises on the most effective techniques for forecasting and managing clinical trial materials needs. Topics covered include:
Speaker: Hedley Rees, Managing Consultant, Pharma Flow
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Clinical research compliance experts Jennifer Mallory and Carrie Hanger provide an overview of changes in the Common Rule set to take effect in January 2019. They discuss:
Speakers: Jennifer Mallory and Carrie Hanger, partners, Nelson Mullins Riley & Scarborough
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Clinical trial contracting experts Suzanne Caruso and Brooke Millman discuss negotiating and finalizing site contracts to ensure that you begin your next study holding all the cards: quick startup, decreased costs, no unnecessary terms and conditions that cause hassles and delays. They cover:
Speakers: Suzanne Caruso, Vice President, Clinical Solutions, and Brooke Millman, Vice President, Consulting Solutions, WIRB Copernicus Group
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Clinical trial specialists Kari Lotsberg and Fabian Sandoval discuss the value of having staff dedicated solely to patient recruitment. They cover:
Speakers: Kari Lotsberg, Manager of Site Services, ThreeWire; Fabian Sandoval, CEO & Research Director at Emerson Clinical Research Institute.
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A panel of clinical trial experts discusses the implications and opportunities presented by the developing field of gene therapy. They talk about:
Speakers: Lindsay McNair, Chief Medical Officer, WIRB-Copernicus Group; Jill Johnston, President, Site Support & Management for Clinical Services, WCG; Karmen Trzupek, Director of Clinical Trial Services and Director of Ocular and Rare Disease Programs, InformedDNA
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IT experts Brian Mundy and Steven Beales discuss the importance of using clinical trial portals. Topics include:
Speakers: Brian Mundy, Director of Product Strategy, and Steven Beales, Senior Vice President of IT, WCG ePharmaSolutions
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