CFPA Home Page
QuickJump
 
               
Browse By Industry
SummaryCourse DirectoryTuitionAccreditationsVenueOfferings
Notify MeE-mail to a Friend



Course ID:
448

Join Our
Mailing List
Email:


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

Online Registration is not available at this time. Click on the Notify Me button to the left to be notified when online registration is available.

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

Other Courses of Interest

Best Practices in SAS Statistical Programming for Regulatory Submission

Biosafety of Biological Drug Products

CMC Submissions in CTD Format
May 17 2012
, New Brunswick, NJ

Developing Specifications for Drug Substances and Drug Products
May 07 2012
, Burlingame, CA

Early Stage Clinical Studies for Drugs and Devices

Generic Drug Approvals

Good Clinical Practices (GCP)

Non-Clinical Drug Safety Evaluation and Drug Development
Feb 22 2012
, Burlingame, CA

Preparation, Packaging and Labeling of Clinical Trial Materials
Feb 20 2012
, Amsterdam, The Netherlands


Related Industries

Click on a button to review other courses in a related industry.

For industry descriptions, please place your cursor over buttons.