InstructorRoyed Training
TypeOnline Course
Price$180 USD / 7500 INR
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505b2 application submission and guidance

Course Code: RYD-020

Course Title: Competency Development Training in 505(B)(2) application submission and guidance.

The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant.

The 1 Week short Certification course is designed to provided comprehensive understanding of the 505(b)(2) pathway. 

Duration: 7 Days

Learning Objectives:

  • Introduction to NDA
  • Review the different pathway for submission
  • Detailed Understanding to 505(b)(2) pathway
  • Understanding of drug candidates for 505(b)(2) pathway
  • Case studies on 505(b)(2) pathway
  • Difference between 505(b)(2) pathway and ANDA
  • 505(B)(2) review timeline
  • Be able to describe experiences of others regarding real world issues associated with creating and submitting 505(b)(2) applications
  • Able to use a checklist to construct a 505(b)(2) from scratch.

Who will Benefit:

  • Person working in the pharmaceutical manufacturing department / F&D personnel
  • Regulatory Affairs personnel
  • Research and Development personnel
  • Quality Assurance & Control personnel
  • Development and Preparation of Submission Materials

Certification: Certificate will be provided at the end of the course after completion of the final examination.

Section 1Learning Sessions
Lecture 1Advance Learning on 505B2 Pathway
Lecture 2Chemistry, Manufacturing & Controls 
Lecture 3Introduction to Common Technical Document (CTD)
Lecture 4CMC Dossier & Compliance Management
Lecture 5Detailed Understanding on ANDA Submission Dossier 
Lecture 6Prior Approval Submission 
Lecture 7Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 8NCE Vs. 505b2 application - Case Based Learning 
Lecture 9Classic case study of the 505b2 filing : Case Based Learning
Section 2Final Examination