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This course is available as a client site course. Please click here for more information.

Who Should Attend
This course is directed to personnel who are responsible or participate in:

  • New Pharmaceutical Product Development: Project
    Managers, Research Coordinators
  • Preclinical and Clinical Researchers who submit INDs,
    NDAs in CTD Format
  • Regulatory Affairs personnel responsible for submitting
    INDs and NDAs to FDA
  • Quality Assurance Departments
  • Marketing Division Personnel involved in New Drug
    Development Decision Making

Participants should have some knowledge of the pharmaceutical development process and/or intend to be involved in new product applications for US submissions to FDA.

The content of this course is to present detailed components of INDs/NDAs, in the CTD format (Modules 1-5). These regulatory submissions will be based on the requirements of the US Code of Federal Regulations, and ICH guidelines. Each of these regulatory documents will be presented as they are related to safety, quality and efficacy. Details of preclinical data, clinical data, and CMC data necessary to achieve new product approvals in the US will be presented. Recommendations for expediting new product approvals will be correlated with the regulatory procedures used by FDA.

Other topics presented that will help participants understand the structure and bureaucratic demands will include:

  • FDAs internal structure, policies and procedures
  • Regulation and requirements for new product submissions
  • Acceptance of international data for use in new product
    approvals in the US
  • Correlations of EU directives, FDAs Code of Federal
    Regulations and ICH guidelines