Course Description


This course is currently at capacity or unavailable for registration, please contact Customer Service at (732)613-4500 or for more information.

Course ID 448

In-Person Course

Who Should Attend?
This course is directed to:

  • Pharmaceutical personnel who are responsible for or interact with clinical and regulatory departments that develop Drugs, Biologics and IVDs
  • Medical and Regulatory Directors, Project Managers, Research Coordinators and Marketing personnel in new product development
  • Clinical Researchers and Regulatory personnel responsible for submitting INDs, NDAs, BLAs and IVD PMAs
  • Quality Assurance and Pharmacovigilance Departments Participants should have some knowledge of the pharmaceutical development process and/or intend to be involved in new product applications for FDA submissions
RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.

Course Description
The intricate components of IND, NDA, BLA and IVD PMA applications for FDA approvals will be detailed based on the requirements of the US code of Federal Regulations, ICH Guidelines and the agencies recommendations. These applications will be correlated with how to submit them in the CTD format (Modules 1-5). Each of these regulatory documents will be presented as they are related to safety, quality and efficacy. Details of preclinical/nonclinical data (pharm./tox) clinical data and CMC requirements for substance and product necessary to achieve new product approvals in the US and globally will be presented.

Other topics include:
  1. FDAs internal structure, policies and procedures and meeting outcomes
  2. Regulations and requirements for new product submissions (PDUFA, FDAAA, FDASIA, MDUFA and GDUFA)
  3. Acceptance of international data for use in new product approvals in the US
  4. Correlations of EU directives, FDAs Code of Federal Regulations and ICH guidelines

Course Director
To Be Determined

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