CMC Considerations for INDs and NDAs for 505(b)(2) Products

Speaker

Instructor: Peggy Berry
Product ID: 705928
Training Level: Intermediate

Location
  • Duration: 90 Min
In this webinar attendees will learn which products qualify for submissions under 505(b)(2), data that may be referenced, content requirements, and regulatory benefits.
RECORDED TRAINING
Last Recorded Date: Jan-2019

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$349.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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Why Should You Attend:

NDAs submitted under FD & C 505(b)(2) are those for which the product is not a generic nor a traditional brand. Learn the requirements for studies, reference information, and marketing requirements to take advantage of this great sponsorship opportunity.

NDAs submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) 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 millions of dollars.

Areas Covered in the Webinar:

  • What is a 505(b)(2) NDA
  • What products qualify for submission under 505(b)(2)
  • Examples of data and information 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
Instructor Profile:
Peggy Berry

Peggy Berry
Founder, Synergy Consulting LLC

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. Prior to founding Synergy Consulting, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).

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