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.
Official Website: https://compliance2go.com/index.php?option=com_training&speakerkey=45&productKey=179
Added by Jay Sylvester on September 27, 2012