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

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299