2014 - Webinar on 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. The new guidance that have resulted from “Refusal-to-Accept” and Electronic Submissions of Medical Device applications will also be presented.
Areas Covered in the Session :
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
Elimination of Exemptions for Registration Fees
Electronic Copy Provision
Implementation of MDUFA III
Hiring
Required MIII Guidance
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
Clinical Trial Physician / Doctor
Manager to Senior Director of
Regulatory Affairs
Quality Assurance
Clinical Research
Data Management
Data Monitoring
Institutional Review Board
For more information contact:
Compliance Trainings
5939 Candle brook Ct,
Mississauga, ON L5V 2V6,
Canada
416-915-4458
Email : support-AT-compliancetrainings.com