Webinar On Medical Device User Fee Act (MDUFA) III
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Description: | 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 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 For more information contact Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Support : 416-915-4458 Email : support@compliancetrainings.com |
URL: | https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1056 |
Date: | Friday, June 20, 2014 |
Time: | 5:00pm-6:30pm UTC |
Duration: | 1 hour 30 minutes |
Access: | Public |
Category: | Webinar*, Technology* |
Created by: | Public Access |
Updated: | Tuesday, June 17, 2014 11:14am UTC |
: | $249 |
: | 416-915-4458 |
: | suzzane.d@compliancetrainings.com |
: | Compliance Trainings |
: | 4169154458 |
Comments: | None |