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Live Webinar FDA Decisions For IDE Clinical Investigations Date: Tue, December 23, 2014 Instructor:Albert A. Ghignone
Time: 10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
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Location: Online
Overview: This webinar provides information on FDA IDE decisions to allow clinical investigations. This webinar provides information involving FDA IDE decisions, IDE approval, IDE approval with conditions, staged approval and IDE disapproval. The webinar will also address FDA communications during this IDE process.
Areas covered in the session: FDA IDE Decision Process IDE Approvals IDE Approval with Conditions Staged Approval IDE Disapproval FDA Communications Regulatory Implications during IDE Process
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 IDE Decision Making Process
About Speaker Albert A. Ghignone Chief Executive Officer and President, AAG Incorporated Albert A. Ghignone MS, RAC, is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and
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