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Boston Professional Events List


3 Hrs Webinar on 505(b)(2) NDAs By Peggy J. Berry, (Ex FDA)


Date
Nov 16, 2021 - 01:00 PM
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, $479 CD/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.

NDAs submitted under section 505(b)(2) of the FD & C Act allow sponsors to reference data that was not generated by them. This type of submission can shave years off of the development process and save millons of dollars. Attend this webinar to learn which products qualify for submissions under 505(b)(2) , data that may be referenced, content requirements, and regulatory benefit

 

Areas Covered

  • What is a 505(b)(2)

  • What products qualify for submission under 505(b)(2) and which do not.

  • Examples of data that may be referenced

  • Requirements for studies to be conducted

  • Submission content requirements

  • Limitations to and benefits of a 505(b)(2)

 

Who will Benefit

  • Manufacturing,

  • supply chain,

  • technical operations,

  • quality control,

  • quality assurance,

  • regulatory affairs

     



Speaker Details


Speaker

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




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