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®.
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
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
World Vaccine Congress - 4/22/2008
- Facilitating Development of and Access to New Vaccines: An FDA Perspective (PDF - 129 KB) - Karen Midthun, MD
51st Annual FDLI & FDA Conference - 3/26-27/2008
- Vaccine Safety Team (PDF - 300 KB) - Carmen M. Collazo, PhD
- Safety Surveillance for Licensed Biological Products at FDA's Center for Biologics Evaluation & Research (PDF - 206 KB) - Robert P. Wise, MD, MPH
- CBER Safety Initiatives: Tissue Safety Team (PDF - 47 KB) - Ruth Solomon, MD
- Blood Safety Team (PDF - 26 KB) - Jonathan C. Goldsmith, MD
Overview of the Regulation of Biological Products (Blood Components and Tissues) - 3/12/2008
-
Surveillance and Enforcement (PDF - 88 KB) - Armando Zamora
-
The Regulation of Biological Products (PDF - 788 KB) - Judy Ciaraldi, Linda S. Mattingly, Armando Zamora, Sharon O'Callaghan, Laura St. Martin, MD
-
Regulation of Biological Products - Review (PDF - 711 KB) - Judy Ciaraldi, Linda S. Mattingly, Armando Zamora, Sharon O'Callaghan, Laura St. Martin, MD
-
FDA Field Inspections (PDF - 60 KB) - Linda S. Mattingly
-
FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (PDF - 173 KB) - Laura M. St. Martin, M.D., M.P.H.
FDLI 6th Annual Enforcement and Litigation Conference - 2/19-20/2008
- Biologics Compliance (PDF - 63 KB) - Mary Malarkey
Washington Vaccine Forum 2008 - 1/30/2008
- Vaccine Safety and Risk Management Update (PDF - 67 KB) - Florence Houn, MD, MPH
Massachusetts Biotechnology Council's Annual Luncheon - 1/22/2008
- Resolutions and Revolutions - Some Perspectives (PDF - 286 KB) - Jesse Goodman, MD, MPH
11th Annual FDA and the Changing Paradigm for Blood Registration Meeting - 1/16-18/2008
- Registration and Licensure (PDF - 781 KB) - Judy Ellen Ciaraldi