Meeting the Regulatory Requirements for Biologic License Applications (BLA's)

Day 1:

Meeting the Regulatory Requirements for BLA's

  • FDA Organization
  • Organization and Content of BLA's
  • FDA Review of BLA's
  • Recent Changes
  • Regulatory Intelligence
  • Case Studies

Day 2:

Preparing for the NDA Submission

A real-time exercise during which the company begins to fill in the Table of Contents of the BLA, assembles the documents available thus far and starts to plan for the submission.

Understanding FDA's Pre-Approval/
Pre-License Inspection Program
  • The Program
    --Objectives
    --Roles
  • What is Reviewed?
    --Records Required for PAI
    --Samples
  • Equivalency of Plants/Batches
  • The Foreign Inspection Program
  • Preparing Pharmaceutical Development Reports
  • Validation
  • Inspections of Pharmaceutical Quality Control Laboratories
    --Preparation
    --The Inspection Approach
  • Cleaning Validation
  • Preparation for the PAI
  • FDA-483 Observations
  • The Suspector Calls: PAI/PLI Do's and Don'ts