Interpreting FDA’s New Guidance Document on Risk-based Monitoring

Why Should You Attend:

The drastic changes in the global macroeconomic environment is forcing biopharmaceutical, medical device and CRO enterprises to find new ways to operate more productively, strategically and cost effectively in today's economy.

The first 30 min. of this presentation will describe the macroeconomic challenges and their effects on biopharmaceutical, medical device, and CRO industry clinical trials. Further, this section of the presentation will contain information about interpreting FDA's new guidance on risk-based monitoring practices, and will offer a case study as to how a clinical team leveraged breakthrough techniques to efficiently assess the quality of drug temperature excursions & regulatory documents and reconciled the trial master file on an outsourced study in record time, which resulted in cost savings and improved productivity.

The remaining 30 min. of the presentation will contain an engaging discussion from an expert that will cover additional details on the topics discussed, and will allow participants the opportunity to ask questions and engage in discussions with experts.

Areas Covered in the Seminar:

• Global macroeconomic challenges & their effects on clinical trials.
• Interpretation of FDA's new guidance document on risk-based monitoring.
• Case study on risk-based monitoring.
• ICH/GCP in the new economy.
• Implementation of breakthrough tools to save costs, improve productivity, optimize monitoring operations and enhance clinical trial operational strategy.
• Efficiently improving clinical trial quality through risk-based monitoring.