Understanding US-FDA Drug Submissions Procedures

Attend this course and be able to:

  • Clarify the needs, expectations and regulatory requirements of the FDA
  • Identify the key elements of US INDs and NDAs
  • Prepare successful Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)
  • Achieve faster drug registration in US
  • Learn the procedures to obtain information from the FDA

This course will help you gain a thorough and practical understanding of:

  • The laws and regulations governing the registration of prescription drugs in the US
  • The organizational structure of the FDA
  • The critical elements of US INDs and NDAs
  • The various types of NDAs
  • Data requirements for INDs and NDAs
  • The NDA and BLA in the CTD Format
  • The technical aspects of preparing INDs and NDAs
  • How to obtain information from the FDA
  • Arranging meetings at the FDA
  • The logistics of sponsor-FDA interactions
  • The myriad of acronyms used in the US drug industry (IND, NDA, MAPPs, IRB, PDUFA, etc.)

Who Should Attend?

The course has been specifically designed to address the training needs of executives who are or will be involved in the preparation of development plans and/or registration dossiers for the US market such as:

  • Regulatory Affairs Personnel
  • Compliance Managers
  • Documentation Managers
  • Project Managers
  • Marketing Managers
  • Clinical Research Personnel
  • Key contributors to the submission packages for the US market

Certificate of Attendance
All participants completing the course will receive a certificate of attendance