INDs/NDAs/CTDs
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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.
Description
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