1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com

Course Content:

Overview of the Regulation of Biologically-derived Products and the IND Process 

• What is a Biologic? What constitutes a Biopharmaceutical?

• Pertinent Laws and Regulations

• Product Jurisdiction and Organization of CBER and CDER

• What to expect from the transfer of biopharmaceutical product regulation from CBER to CDER

• The Investigational New Drug Application (IND) Process

  • "Nuts and Bolts" of the IND Application

    • The Forms 1571 and 1572

    • The CMC Section

    • Preclinical Studies

    • Phase I Clinical Trial Issues

• Types of IND's including Treatment and Emergency IND's

• Product and Clinical Development under IND

• The Pre-IND Process

• Meetings and Communications with the FDA during the IND Process

• ICH Guidelines

• IND Case Study

The License Application and The Food and Drug Administration Modernization Act (FDAMA) of 1997

• The License Application (LA)

  • The LA for Biopharmaceutical Products

  • Implementation of the LA for all Biologic Products

  • The Managed Review Process

  • The Refuse-to-File Policy

  • FDA Advisory Committees 

• The Food and Drug Administration Modernization Act (FDAMA) of 1997

  • "Fast Track" Designation

  • FDA Meeting Policy

  • Effects of FDAMA on License Application Review

  • License Application Case Study

Manufacturing and Establishment Issues

• Manufacturing and Product Characterization Issues 

  • The Pilot Manufacturing Facility Policy 

  • 21 CFR 601.12 - Changes to be Reported (1997 revisions)

  • Product Characterization and Lot Release Issues

  • Manufacturing "Scale-Up" Issues 

  • Comparability Protocols and Product Manufacture Bridging

• Establishment and Inspection Issues

  • Process Validation Issues

  • Quality Assurance and Quality Control Overview

  • "TEAM BIOLOGICS" and Inspection of Biologics Manufacturing Facilities

  • Contract Manufacturing 

• Product Manufacture and Bridging Case Study

Upcoming Regulatory Issues