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Annual Reports for Approved PMAs
This Webinar is over| Date | Nov 26, 2014 |
| Time | 01:00 PM EDT |
| Cost | $149.00 |
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Online
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Overview :
This webinar describes the information required by FDA to be submitted in a PMA annual report. The webinar also discusses FDA recommendations for level of detail the applicant should provide in the PMA annual report. Also addressed are the steps FDA staff generally takes when reviewing annual reports and the actions FDA may recommend after the annual report review. Also covered in this webinar are other reports - post-approval study reports.
Why Should You Attend: This webinar is a must for those who have to have an understanding of FDA's annual report requirements for approved PMAs
Areas Covered in the Session:
Who Will Benefit:
This webinar describes the information required by FDA to be submitted in a PMA annual report. The webinar also discusses FDA recommendations for level of detail the applicant should provide in the PMA annual report. Also addressed are the steps FDA staff generally takes when reviewing annual reports and the actions FDA may recommend after the annual report review. Also covered in this webinar are other reports - post-approval study reports.
Why Should You Attend: This webinar is a must for those who have to have an understanding of FDA's annual report requirements for approved PMAs
Areas Covered in the Session:
- Purpose of PMA Annual Reports
- Contents of PMA Annual Report
- Detail Required in a PMA Annual Report
- FDA Review of PMA Annual Report
- Actions FDA May Recommend After PMA Annual Report Review
- Post-Approval Study reports
Who Will Benefit:
- Regulatory Affairs Personnel
- Quality Personnel
- Research Personnel
- Clinical Personnel
- Project Managers
- Legal Personnel
- Those personnel that require a general understanding of the FDA's PMA Annual Report Process
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