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Clinical Auditing Forum


 

 

Barnett International and Cambridge Healthtech Institute (CHI) are pleased to announce the Inaugural Clinical auditing Forum. The focus of the Forum will be on regulatory agencies’ changing focus and expanding expectations regarding GCP compliance. Being led by thought leaders and industry experts, the conference will feature best practices, strategies, and techniques to ensure that solid GCP compliance and scientific and ethical standards are maintained throughout the conduct of clinical trials. attendees can expect case studies, hands-on activities, take-away tools, and interactivity throughout the conference. sessions will be focused on strengthening auditing programs, implementing proven techniques for audit planning, and ultimately ensuring clinical research compliance through strategic approaches to clinical quality assurance. Perspectives on FDA activities will also be shared, including how auditing planning is affected by recent inspection trends.

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
 

 



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