Presentations
Presentations are in chronological order, with the most recent event at the top of the list. They will be removed after one year. If you want to keep the slides for future reference, they may be downloaded and saved. Slides that have been removed from the web site may be requested by submitting a written request to FDA's Freedom of Information Staff.
Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.
Note: Documents in PPT format require the PowerPoint Viewer®. If you experience problems with PPT documents, please download the latest version of the Viewer®.
5th Annual FDA and the Changing Paradigm for HCT/P Regulation - 1/28/2009
- HCT/P Compliance Update (PPT - 412 KB) - Mary Malarkey
12th Annual FDA and the Changing Paradigm for Blood Regulation - 1/14 - 1/16/2009
- FDA Perspective on “Where are we? Where can we go?” (PPT - 261 KB) - Gilliam B. Conley
5th Annual FDA and the Changing Paradigm for HCT/P Regulation - 1/2009
- Writing An Effective 483 Response (PDF - 344 KB) - Anita Richardson
Adjuvants and Adjuvanted Preventative and Therapeutic Vaccines for Infectious Disease Indications - 12/2 - 12/3/2008
- Workshop: Adjuvants and Adjuvanted Preventive and Therapeutic Vaccines for Infectious Disease Indications (PDF - 149 KB) - Jesse L. Goodman, MD, MPH
- Public Workshop: Adjuvants and Adjuvanted Preventive and Therapeutic Vaccines for Infectious Disease Indications (PDF - 129 KB) - Norman W. Baylor, Ph.D.
CDISC International Interchange - 10/30/2008
- CDISC Activities at the Center for Biologics Evaluation and Research (CBER) (PDF - 33 KB) - Amy Malla
- Responding to Vaccine Safety Events (PPT - 597 KB) - Karen Midthun, MD
- Post-Marketing Surveillance: Passive and Active Approaches and Use of Electronic Databases (PPT - 411 KB) - Karen Midthun, MD
PDA/FDA Joint Meeting - 9/9 - 9/10 2008
- FDA Compliance Update: Quality Systems (PDF - 49 KB) - Mary Malarkey
- Road to First Cycle Approval for Post – Approval Changes – CBER/FDA Perspective (PDF - 60 KB) - Laurie P. Norwood
- CBER Update (PDF - 112 KB) - Mary Malarkey
BIO, International Convention, San Diego, California - 6/17-20/2008
- Revolutions and Resolutions-Some Perspectives for 2008 (PDF - 400 KB) - Chris Joneckis, Ph.D.
- Reviewers' Advice to Emerging Companies and First-Time Filers (PDF - 383 KB) - Chris Joneckis, Ph.D.
American Society of Clinical Oncology - 6/2/2008
- FDA and Cancer Vaccine Development (PDF - 100 KB) - Celia Witten, Ph.D., M.D.
Society of Clinical Research Associates (SoCRA) - 5/22-23/2008
- Working with Center for Biologics Evaluation and Research and Suggestions for Successful Clinical Trials (PDF - 605 KB) - Patricia Holobaugh
- The Inspection is Over - What Happens Next? Possible FDA Enforcement Actions (PDF - 90 KB) - Patricia Holobaugh
Infectious Disease Society of America (IDSA) - 5/19/2008
- Immunization Before the Next Pandemic? Risks, Benefits and Pathways (PDF - 2.3 MB) -Jesse Goodman, MD, MPH