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Barnett International Announces New Fall-Winter Courses 

Needham, MA, September 29, 2011 - Barnett International announced today the launch of nineteen new in-person and web-based courses. In addition to updating its current portfolio of offerings for the remainder of 2011, these new courses were added to further serve the constantly evolving training and educational needs of global clinical research professionals today.

New In-Person Courses:

  • Approaches to Pre- and Post-Marketing Risk Assessment and Risk Management
  • Conducting Clinical Trials in Resource-Limited Settings and Enrolling Vulnerable Subjects: Challenges and Solutions
  • Effectively Writing the Investigator's Brochure
  • Good Clinical Practice for the Laboratory Scientist
  • The Highly Effective CRA: Soft Skills for Taking Your Work to the Next Level

New Web-Based Courses:

  • Case History Maintenance in Clinical Trials
  • De-Risk Your Protocol by Developing an Operational Advisory Board
  • Disqualification of Clinical Investigators: Proposed Rule and FDA Transparency Initiative
  • Electronic Source Documentation: Navigating the New FDA Draft Guidance
  • FDA's Bioresearch Monitoring (BIMO) Program: New Guidance for Inspection of Sponsors, CROs, and Monitors
  • Financial Disclosure: New FDA Draft Guidance for Clinical Investigator Reporting
  • Implications of the Anticipated Reissue of the Guideline for the Monitoring of Clinical Investigations
  • March 2011 Compliance Program Guidance Manual Update: Recommendations for the Inspection of Sponsors, CROs, and Monitors
  • New FDA Guideline to Informed Consent
  • Principal Investigator Oversight and the Appropriate Delegation of Tasks
  • Risk-Based Site Monitoring
  • Risk Management Strategies for International Regulatory Requirements
  • Worldwide Fast Track, Priority Review, and Accelerated Approval Option
  • Worldwide Orphan Drug Designation Applications and Requirements

“Barnett’s new courses address key issues and identified training needs frequently requested by our clients,” said Naila Ganatra, GM of Barnett International. “Of particular note is a series of new courses that focus on FDA Guidances - new releases and recent updates. Each course will assess the implications of the guidance on current practices and provide an assessment of FDA’s expectations.”

Barnett’s new courses are available as both in-person and web-based training options, providing a high degree of flexibility for Learners.

To view Barnett International’s portfolio of training opportunities, including industry publications, on-site training programs, eLearning programs, and other consulting opportunities, please visit:

About Barnett International: Founded in 1979, Barnett International is widely recognized for its superior consulting services and its targeted education and training programs. Barnett helps clients get the most out of their research and development dollars by managing change effectively, improving organizational performance, and enhancing staff knowledge. The Barnett approach is a unique combination of strategy development and practical, hands-on implementation. The "Barnett Difference" is evident in our deep understanding of the clinical research process and in the rapid and tangible performance improvements we deliver.