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
Other Courses of Interest
Best Practices in SAS Statistical Programming for Regulatory Submission
Biosafety of Biological Drug Products
CMC Writing and Submission Strategies: A Global Regulatory Approach
Sep 16 2013, East Brunswick, NJ
Developing Specifications for Drug Substances and Drug Products
Jun 03 2013, Amsterdam, The Netherlands
Developing Specifications for Drug Substances and Drug Products
Oct 07 2013, New Brunswick, NJ
Early Stage Clinical Studies for Drugs and Devices
Generic Drug Approvals
Aug 13 2013, New Brunswick, NJ
Good Clinical Practices (GCP)
INDs/NDAs/CTDs
Jun 18 2013, Burlingame, CA
INDs/NDAs/CTDs
Nov 11 2013, Amsterdam, The Netherlands
Non-Clinical Drug Safety Evaluation and Drug Development
Jul 08 2013, Amsterdam, The Netherlands
Preparation, Packaging and Labeling of Clinical Trial Materials
Sep 19 2013, East Brunswick, NJ
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