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Regulatory Affairs Part II: The NDA Phase

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Learn about US Food and Drug Administration (FDA) regulations and expectations for the content, submission, and review of new drug applications (NDAs) and the importance of regulatory strategy. This blended learning opportunity features two archived online courses focusing on fundamental concepts, followed by a training course consisting of interactive lectures and hands-on workshops. Learn about FDA history, regulations, roles and responsibilities, and organization relative to the development of pharmaceuticals and biologics in the United States. Learn the processes characteristic of pharmaceutical and biologic product discovery, development, and commercialization.

What You Will Learn 

  • Fundamentals of the NDA process
  • Post-approval marketing requirements for NDAs
  • Meetings and other interactions with FDA
  • Historical perspectives of pharmaceutical and biologic regulation
  • Key legislative milestones and impact on product development
  • Overview of the organization, roles, and responsibilities of FDA
  • Key regulatory definitions
  • Three stages of new pharmaceuticals and biologics
  • Overview of chemistry manufacturing and controls processes
  • Highlights of nonclinical studies
  • Description and definition of clinical phases of study
  • Expectations after the approval of new products

Who Should Attend 

  • Regulatory affairs professionals new to the NDA
  • Clinical development professionals
  • Biostatisticians
  • Basic researchers
  • Quality professionals
  • Medical writers
  • Clinical research academicians
  • Business and marketing professionals

Learning Objectives 

Participants who complete this course should be able to:

  • Explain the importance of incorporating regulatory strategy into the drug development plan
  • Identify FDA review processes for evaluating NDAs
  • Recognize content and format requirements for NDA/BLA in the Common Technical Document Format
  • Define post-approval requirements
  • Outline the regulatory requirements for prescription drug labeling and advertising/promotion
  • Apply formal meeting principles and practices when interacting with the FDA during the NDA phase

Contact Information 

Jessica McGrory at +1-215-442-6182 or Jessica.McGrory@diahome.org

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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