INDs/NDAs/CTDs
March 09 - 11, 2009
Burlingame, CA
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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.
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