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Pilot Results and Methodologies for Implementing and Executing Successful RBM Programs

November 6-7, 2014
  • Philadelphia, PA

NOVEMBER 6-7, 2014 | HYATT REGENCY AT PENN’S LANDING | PHILADELPHIA, PA

Beyond Theory - Detailed Descriptions and Results on RBM Execution

The way that clinical trials are conducted and monitored is changing, and that change is dramatic. TransCelerate member companies have fully implemented RBM programs. Sponsors, CROs, sites and regulators are developing operational standards. What have been the results?  What were the unexpected implications of RBM execution? What has been the feedback from the FDA? How are the sites reacting? Attend CBI's RBM meeting to find out.

This is the only event dedicated to providing real life examples, lively discussion and practical suggestions on how to implement and fully execute an RBM program. Don't miss the opportunity to participate in progressive discussions on all things surrounding RBM and leave with actionable insights on executing risk-based monitoring programs.

Standing Room Only in 2013 - Reserve Your Seat Today!

  • Hear FDA recommendations for improvements on risk-based monitoring plans
  • Participate in a TransCelerate panel discussion on key insights and lessons learned from pilot studies
  • Examine industry case studies on RBM implementation and execution
  • Tackle challenges beyond identifying risk by documenting risk-decisions and execution
  • Plan for the unexpected impacts of RBM on training, study start-up and metrics

Blog: Boehringer Ingelheim’s Andy Lawton on TransCelerate BioPharma and Risk-Based Monitoring
Andy Lawton (Apr. 01, 2014)
At a recent risk-based monitoring (RBM) conference in Cambridge, Medidata’s RBM expert Steve Young caught up with Andy Lawton, global head of clinical data management at Boehringer Ingelheim and a member of TransCelerate’s RBM workstream. Andy, along with Sanofi’s RBM lead Lori Convy, led a panel discussion providing an industry update on TransCelerate BioPharma and their RBM plans for 2014. Andy additionally gave a presentation focused on the Integrated Quality and Risk Management Plan (IQRMP), a key component of RBM planning that is not only described in TransCelerate’s position paper but also referenced in FDA’s draft RBM guidance and the EMA RBM reflection paper. In this video recap, Andy and Steve discuss best practices around the IQRMP, the need for transparency and more.