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INDs/NDAs/CTDs

 
  January 14, 2010  
     
 
CfPA - The Center for Professional Advancement, Burlingame, CA
March 22-24, 2010


Who Should Attend
This course is directed to personnel involved in:

  • New Pharmaceutical Product Development
  • Pre-clinical and Clinical Research
  • Regulatory Affairs
  • Quality Assurance

Participants should have an understanding of the steps in new product development and/or the responsibilities of regulatory affairs in submitting new product applications worldwide.

Description
The content of this course is to present detailed components of INDs/NDAs, BLAs, ANDAs, SNDAs, IMPDs and CTDs (Modules 1–5). These regulatory submissions will be based on the requirements of the US Code of Federal Regulations, EU Directives and ICH guidelines. Each of these regulatory documents will be presented as they are related to safety, quality and efficacy necessary for global submissions. Details of non and pre-clinical data, clinical data, and CMC data necessary to achieve new product approvals globally will be presented and discussed. Recommendations for expediting new product approvals will be correlated with the regulatory procedures.

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

  • FDAs internal structure, policies and procedures
  • Regulation requirements for new product submissions
    including SNDAs, CTDs and DMFs globally
  • Acceptance of international data for use in new product
    approvals
  • Similarities between EU directives and FDAs Code of
    Federal Regulations and ICH guidelines

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Dr. Richard A. Guarino, President, Oxford Pharmaceutical Resources, Inc.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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