Archived Course Materials

Stakeholders' Meeting Resources (April 7-8, 2005)

Long-Term Follow-Up Workshop Materials Available (July 16, 2004)

Licensure Workshop
The American Society for Gene Therapy and the Food and Drug Administration / Center for Biologics Evaluation & Research (FDA/CBER) held a workshop entitled Non-Clinical Toxicology in Support of Licensure of Gene Therapies March 13-14, 2003 in Arlington, VA.

• Summary Document from March 2003 Toxicology Workshop (PDF file)

2001 Clinical Gene Transfer Training Course Commentary

Supplemental Materials for the Clinical Gene Therapy Training Course (May 29 & 30, 2001) 

FDA Regulations: Title 21 -- Food and Drugs
Chapter I -- Food and Drug Administration, Department of Health and Human Services:

• Part 50: Protection of human subjects  
• Part 54: Financial disclosure by clinical investigators 
• Part 56: Institutional Review Boards
• Part 312: Investigational new drug application
• Part 314: Applications for FDA approval to market a new drug
  

International Conference on Harmonisation (ICH) Guidelines: 

• E6: Good Clinical Practice 
• E2A: Clinical Safety Data Management

Speaker Handouts:

• Clinical Protocol Development - Larry Friedman, MD, NIH
• An FDA Audit: What the Investigator and Sponsor Need To Know - Joseph P. Salewski, PhD, FDA

Gene Therapy Vector Production Conference