Best Practices With Submissions Under Medical Device User Fee Act (MDUFA) III

This webinar will present the results of the MDUFA III and will describe how your company will need to do business with the FDA in the next five years. It will describe how the FDA will use the User Fees to make changes within the agency and the expectations that the FDA will have of your company, as a result of those changes, to help your company prepare both strategically and tactically for regulatory interactions in the next five years.

Why Should You Attend: Change is inevitable; Suffering is optional!!! This is the best way to describe the Medical Device User Fee Act III that, among other things, changes the way that the FDA accepts submissions for Medical Devices. This will cause significant changes in how Medical Device Companies need to handle 510(k) and PMA submissions between the years 2012-2017. This 90-minute webinar will include a review of the changes the FDA is making in accepting Medical Device Submissions and will propose solutions to some of the problems that will result from those changes. The goal of the webinar is to reduce or eliminate suffering from these changes, by discussing the strategies required to move forward with minimal disruption to your business. The new guidances that have resulted from Refusal-to-Accept and Electronic Submissions of Medical Device applications will also be presented. Areas Covered in the Webinar: How the FDA got from MDUFA I to MDUFA III New Law: FDA Safety & Innovation Act (FDASIA) Process & Policy Improvements Updated Quantitative Goals MDUFA III Review Times Infrastructure Improvements Other Provisions Key Highlights o Elimination of Exemptions for Registration Fees o Electronic Copy Provision Implementation of MDUFA III o Hiring o Required MIII Guidance Who will Benefit: Medical Device Regulatory Affairs Medical Device Quality Assurance Clinical Research Clinical Trial Data Management

Data Monitoring Institutional Review Board Clinical Trial Physicians Principal Investigators Clinical Investigators Institutional Review Boards Data Monitoring Committees Medical Device CROs

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