CMC & CTD Considerations for INDs/ANDA's/NDA's for 505(b)(2) Drug Products: Know The Ins And Outs Of 505(b)(2) Regulation And Guidance From The FDA

Duration: 90 Minutes
In this 90 minute webinar, Jerry Dalfors will highlight the key elements of the CMC section of an IND and NDA application for a 505(b)(2) product using examples and case studies. He will discuss the practical strategies for compiling the CMC sections of 505(b)(2) applications and also some key strategic considerations using real-life case studies. Plus, he'll shed light on the role of Drug Master Files (DMFs), and cross reference authorizations.
505(B)(2) Regulation
Instructor: Jerry Dalfors
Product ID: 501282
Areas Covered
  • The 505(b)(2) regulation and guidance from the FDA
  • Strategic considerations for CMC section in a 505(b)(2) application
  • Role of DMFs
  • Best practices for using cross-reference authorization
  • Common errors in CMC section in 505(b)(2) applications and potential solutions
  • Examples of successful strategies for developing such products
Why Should you Attend
The Chemistry, Manufacturing and Controls (CMC) section of IND and NDA applications for 505(b)(2) products raises several issues since portions of the information may come from the reference product with additions unique to the said application. Since such products may contain altered versions of previously FDA-approved drugs, sponsors frequently struggle with defining the detail and scope of information to include in their applications. This webinar will discuss the practical strategies for compiling the CMC sections of 505(b)(2) applications. Key strategic considerations will be discussed using real-life case studies.

Who can Benefit
  • Regulatory affairs professionals
  • Senior management executives (CEO, COO, CFO, etc)
  • Drug discovery and development professionals (R&D and CMC)
  • Intellectual property experts
  • Project Managers and Clinical trial specialists
  • Regulatory Compliance Associates and Managers
  • People investing in FDA-regulated product development projects
Topic Background
The provisions of 505(b)(2) were created to help avoid unnecessary duplication of studies already performed on a previously approved ("reference" or "listed") drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant. 505(b)(2) is particularly valuable for pharmaceutical and generics companies looking to alleviate competitive forces in their environments while still wanting to benefit from a development process that eliminates most nonclinical studies as well as extensive safety and efficacy tests.
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Instructor Profile:
Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.
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