Boston Professional Events List


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


Date
Nov 14, 2017 - 07:00 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, $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

  • 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


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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