ComplianceOnline

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

Instructor: Mukesh Kumar
Product ID: 703393
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

This webinar will highlight the key elements of the Chemistry, Manufacturing and Controls (CMC) section of an IND and NDA application for a 505(b)(2) product using examples and case studies. It will also discuss role of Drug Master Files (DMFs), and cross reference authorizations.

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.

Areas Covered in the Webinar:

  • 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

Who Will 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

Instructor Profile:

Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia.

He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affair professional by the Regulatory Affairs Professional Society, USA.

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