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3 Hrs Webinar on 505(b)(2) NDAs By Peggy J. Berry, (Ex FDA)
Date
Nov 15, 2021 - 07:00 PM
Link to Website
Organizer
conference Manager
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,
Hollywood,
Florida,
United States,
ZIP: 33021
Phone: 347 282-5400
Ticket Price: $349 One Dial-in One Attendee, $859 Group, $379 Recorded, $479CD/DVD
Description
NDAs submitted under FD & C 505(b)(2) are a submission for which it is
Not a generic nor is it a tratitional brand. However, as such a hybrid, it is a great sponsorship opportunity. Learn the requirements for studies, reference information and marketing requirements.
Areas Covered
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What is a 505(b)(2)
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What products qualify for submission under 505(b)(2) and which do not.
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Examples of data that may be referenced
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Requirements for studies to be conducted
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Submission content requirements
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Limitations to and benefits of a 505(b)(2)
Who will Benefit
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Manufacturing,
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supply chain,
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technical operations,
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quality control,
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quality assurance,
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regulatory affairs
Speaker Details
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.
Event Categories
Keywords: Educationa