SPEAKERS INCLUDE: 

• Janice Boyd, Principal CRA, Clinical Study Operations, Abbott Vascular

• Steve Keys, Head of Quality, The Clinical Trial Company Ltd.

• Nikki Christison, Director, Clinical Operations, Centerphase Solutions, Inc.

• Michael G. Duncan, Senior Specialist, Global System Quality Assurance, Johnson & Johnson

• Amnon Eylath, Director, Quality, ARIAD Pharmaceuticals

• Federico Feldstein, J.D., Senior Director, Head of Primary & Consumer Healthcare BU Quality Assurance, Pfizer Medical

• BJ Guthrie, Manager, Clinical Operations, Clinical Research, Abbott Vascular

• Marta I. Jimenez-Aquino, OEX Consulting, Inc.

• Karine Julien, M.Sc., M.B.A., Disease Area Lead, Cardiovascular, Pfizer Medical Quality Assurance

• William H. Kitchens, Partner and Chairman of the Healthcare and Life Sciences Practice Group, Arnall Golden Gregory LLP, and Adjunct Professor, Emory University School of Law

• Jennifer Leonard, Program Manager, Global System Quality Assurance, Johnson & Johnson

• Elizabeth Ronk Nelson, MPH, President and Senior Consultant, Regulatory Risk Management, LLC

• Barbara Osinski, Manager QC GCP Compliance and Training, Clinical Development, Grunenthal USA Inc.

• Susan Radtke, RN, MA, CCRP, Quality Analyst, Norton Cancer Institute

• Kenneth D. Schiff, Proprietor/President, Quality Risk Management Associates, LLC

• Hope Senechal, B.Sc., CCRA, Clinical Research Auditor, Administration, Ottawa Hospital Research Institute

• Johanna L. Stamates, RN, MA, CCRC, Director, Office of Research Compliance Assessment, University of Miami

• Swati Tendolkar, Senior Specialist, Global System Quality Assurance, Johnson & Johnson
   

  
   

• James Tripp, Associate Director, Compliance & Training, Regeneron
  

  
   

• Barbara van der Schalie, Clinical Training Manager, Clinical Monitoring Research Program, SAIC-Frederick

Held in Conjunction with... 

Barnett International & Cambridge Healthtech Institute's
Second Annual Mastering Clinical Trial Monitoring
June 13-14, 2011 * Hilton Boston Back Bay Hotel * Boston, MA 

Topics to be Covered Include: 

• Perspectives on FDA Activities: How Recent Trends Effect Monitoring Activities
• Risk-Based Monitoring: Regulatory Expectations and Industry Trends
• Monitoring in the Electronic Environment: EDC and EMRs
• Hiring, Training, and Retaining Monitors
• The Global Monitor: Meeting Regulatory and Cultural Challenges
• The Unique Challenges of Monitoring Medical Device Studies
• Site Relationship Management: Achieving Both Compliance and Commitment
• Troubleshooting Difficult Sites: Management and Communication Techniques, and Strategies for Achieving Compliance
• The Unique Challenges of the Clinical Research Organization (CRO) Monitor
• Root Cause Analysis and Corrective Actions/Preventive Action Planning for Monitors