Training and Continuing Education

Industry Courses

Professionals

CDER Small Business and Industry Education Series

CDER's Small Business and Industry Assistance Program has developed a series of Web-based courses to educate regulated small pharmaceutical industry. Note that these courses take approximately 1-3 hours to complete.   

  • Electronic Common Technical Document (eCTD)

    [Updated Version] This course provides the essential steps of submitting electronic submissions to CDER, and can serve as a resource for questions about the submission process.
  • Best Practices for Communication Between FDA and IND Sponsors During Drug Development 

    The course describes best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development. 
  • Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA)

    This course informs the user about the GDUFA requirements and process, and can serve as a resource for better understanding of GDUFA. It addresses the rationale and benefits of GDUFA, the review and fee commitments under GDUFA, the metrics and goals associated with GDUFA, the self-identification process, and the drug master file changes required under GDUFA.
  • GDUFA Self-Identification (SPL) Submission – Part 1

    This course is Part 1 of a two-part web-based training course on GDUFA Self-Identification SPL Submission. The overall goal of this training module is to provide a clearer understanding of mandatory information and its format for self-identification under GDUFA. It offers a comprehensive review of the required data elements and their restrictions for the Self-Identification SPL file.
  • GDUFA Self-Identification (SPL) Submission – Part 2

    This course is Part 2 of a two-part web-based training course on GDUFA Self-Identification SPL Submission.  It focuses on guiding firms through a successful self-identification submission process, including uploading SPL submissions and retrieving acknowledgements.
  • Bringing an Over-the-Counter (OTC) Drug to Market

    The purpose of this course is to provide information on navigating the rules and regulations on bringing an OTC drug to market and the associated FDA processes.
  • Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND

    This course is intended to help IND sponsors become familiar with applicable CMC statutes, regulations, and relevant documents. 
  • Engaging with the FDA During New Drug Development

    This course focuses on familiarizing small pharmaceutical business and industry in general with resources available to communicate with FDA, and provides guidance on effectively interacting with FDA throughout the new drug development process.
  • Human Drug Establishment Registration and Drug Listing Compliance

    This course identifies and discusses the statutory requirements regarding the submission of registration and drug listing information, and provides a clearer understanding of the registration and drug listing process.

 

Page Last Updated: 08/03/2017
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