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Live Webinar Formal Meeting Between FDA and Drug-Biologic Sponsors or Applicants Date: Tue, December 9, 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 addresses formal meetings with FDA for Drug/Biologic Sponsors and Applicants. Covered are the types of FDA meetings, how one makes an FDA meeting request, FDA assessment of meeting requests, meeting package content, communications with FDA and meeting procedures.. Also covered are documentation of meetings and resolution of disputes about meeting minutes.
Areas covered in the session: Types of FDA Meetings Request for Meeting Application Meeting Package Contents FDA Assessment of Meeting Requests Communications With FDA Meeting Procedures Meeting Minutes
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 Formal Meeting 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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