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.
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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
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Surveillance and Enforcement (PDF - 88 KB) - Armando Zamora
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The Regulation of Biological Products (PDF - 788 KB) - Judy Ciaraldi, Linda S. Mattingly, Armando Zamora, Sharon O'Callaghan, Laura St. Martin, MD
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Regulation of Biological Products - Review (PDF - 711 KB) - Judy Ciaraldi, Linda S. Mattingly, Armando Zamora, Sharon O'Callaghan, Laura St. Martin, MD
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FDA Field Inspections (PDF - 60 KB) - Linda S. Mattingly
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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
DIA Washington, D.C. Workshop - 1/14/2008
- Vaccine Safety and Risk Management Update (PDF 107 KB) - Florence Houn, MD, MPH
American Course on Drug Development and Regulatory Sciences - 1/10/2008
- Vaccine Safety: An FDA Perspective (PDF - 129 KB) - Karen Midthun, MD
Fourth Annual FDA and the Changing Paradigm for HCT/P Regulation, San Antonio, Texas - 1/8-11/2008
- HCT/P Compliance Update (PDF 93 KB) - Mary Malarkey, OCBQ, CBER
- Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Melissa Greenwald, MD
Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - 12/10-11/2007
FDA/NIST Sponsored Workshop - In Vitro Analyses of Cell/Scaffold Products - 12/6-7/2007
WilBio 2nd Annual Cell Banking Meeting - 12/5/2007
- Regulatory Guidance on Using New Cell Substrates for Manufacture of Viral Vaccines (PDF - 250 KB) - Arifa S. Khan, PhD
Society of Clinical Research Associates: FDA Clinical Trial Requirements Regulations, Compliance, and GCP Conference - 11/14-15/2007
- Working with Center for Biologics Evaluation and Research and Suggestions for Successful Clinical Trials (PDF - 579 KB) - Patricia Holobaugh
- The Inspection is Over - What Happens Next? Possible FDA Enforcement Actions (PDF - 94 KB) - Patricia Holobaugh
DTRA 2007 Biodefense Conference - 11/07/2007
- FDA/CBER’s Role in Facilitating Development of and Access to Medical Countermeasures (PDF - 352 KB) - Cynthia Kelly
US Regulatory Perspective on Preventive Vaccine Development (Office of Scientific Resource Development, NIAID, NIH) - 10/30/2007
- IND Overview (PDF - 409 KB) - LCDR Vada Perkins
- Regulatory Considerations for the Manufacture of Investigational Vaccines for Clinical Trials (PDF - 495 KB) - CDR Jon R. Daugherty, Ph.D.
- Regulatory Aspects of the Nonclinical Safety Assessment of Adjuvanted Preventive Vaccines (PDF - 454 KB) - Steven Kunder, Ph.D., DABT
- Regulatory Perspective on Development of Preventive Vaccines for Global Infectious Diseases (PDF - 618 KB) - Rosemary Tiernan, MD, MPH
Mid-Atlantic Bio - 10/25/2007
- Cell Therapy and FDA Regulation (PDF - 80 KB) - Celia M.Witten, Ph.D., M.D.
2nd Annual FDA Inspections Summit - 10/23/2007
- Challenges in Biologics Compliance (PDF - 164 KB) - Mary Malarkey
DIA Philadelphia Workshop - 10/18/2007
- Vaccine Risk Management (PDF 261 KB) - Florence Houn, MD, MPH
ISCT 7th Annual Somatic Cell Therapy Symposium - 9/26-28/2007
- Facility and Operational Issues for Cord Blood Banks: FDA Draft Guidance (PDF - 276 KB) - Mary Malarkey
- Office of Cellular, Tissue, and Gene Therapy: Update - Celia Witten, Ph.D. MD
PDA/FDA Joint Regulatory Conference - 9/27/2007
- Global Harmonization: GMP Compliance Issues (PDF - 179 KB) - Mary Malarkey
- Assuring the Quality of Raw Materials used to Manufacture Cellular Products: Regulatory Considerations (PDF - 244 KB) - Donald W. Fink, Jr., Ph.D.
- CBER Perspective (PDF - 521 KB) - Chris Joneckis., Ph.D.
RAPS 2007 Annual Conference and Exhibition - 9/24/2007
- CBER 2007 - Celia Witten, Ph.D. MD
New Cells for New Vaccines II - 9/19/2007
- US Regulatory Perspective on New Cell Substrates for Manufacture of Viral Vaccines (PDF - 151 KB) - Arifa S. Khan, PhD
American Association of Tissue Banks Annual Meeting - 9/17/2007
- FDA Update: Relevant to Reproductive Establishments - Martha A. Wells, MPH, RAC
- FDA Update - Melissa Greenwald, M.D.
Malaria Vaccines for the World - 9/17-19/2007
- Regulatory Issues in Malaria Vaccine Development (PDF - 474 KB) - Jon R. Daugherty, PhD
Joint Commission Resources - Strategies for Transplantation Safety and Quality - 8/29/2007 & 9/6/2007
- U.S. Food and Drug Administration Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products (HCT/Ps) - Laura M. St. Martin, M.D., M.P.H. & Celia M. Witten, Ph.D., M.D.
- CBER Update (PDF - 211 KB) - Mary Malarkey
- CMC Regulatory Review and CGMP Systems in CBER (PDF - 957 KB) - Chris Joneckis, Ph.D.
FDA Workshop - Licensure of Apheresis Blood Products - 8/15/2007
- Apheresis Licensing Workshop - Gambro BCT-Specific Information (PDF - 112 KB) - Merilyn Wiler, MT (ASCP) SBB, Gambro
- Fenwal Automated Devices: FDA Licensing Workshop (PDF - 118 KB) - Sharyn Orton
- Licensure of Apheresis Blood Products: The Regulatory Paradigm and Managed Review (PDf - 166 KB) - Alan Williams, Ph.D.
- Revisions to the Requirements Applicable to Blood, Blood Componenets and Source Plasma (PDF - 115 KB) - Elizabeth Callaghan
- FDA Review of Apheresis Submissions (PDF - 410 KB) - Judy Ellen Ciaraldi
- Collection of Platelets by Automated Methods Guidance Documents (PDF - 158 KB) - Lore Fields, MT (ASCP) SBB
- Licensing of Haemonetics Products (PDF - 29 KB) - Sue Finneran
- Blood Systems’ Licensure of 5 & 7-day Platelets (PDF - 27 KB) - Kathleen Hopping
- Preparing Apheresis License Submissions (PDF - 630 KB) - Stephen Kassapian
- Impact of very frequent plateletpheresis on donor platelet counts (PDF - 267 KB) - Louis M. Katz MD
- Experiences with a Failure Investigation Program for Apheresis Blood Products (PDF - 82 KB) - Faye Kugele
- Top Ten Pitfalls With Submissions (PDF - 78 KB) - Rosia E. Nesbitt
- FDA Regulations and Recommendations for Failure Investigations (PDF - 74 KB) - Hoi-may Wong
American Association of Bioanalysts Annual Meeting - 5/17/2007
- FDA Update: Relevant to Reproductive Establishments - Martha A. Wells, MPH, RAC
- Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Martha A. Wells, MPH, RA
BIO - 5/7-8/2007
- CBER 2007: Brief Bio Update (PDF - 335 KB) - Jesse L. Goodman, MD, MPH
FDA Workshop: Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing - 4/25-26/2007
- Welcoming Remarks (PDF - 47 KB) - Jesse Goodman, MD, MPH
- Introduction to the Workshop (PDF - 81 KB) - Dorothy Scott, MD
- Welcome (PDF - 151 KB) - Jan M. Bult
- Measles Neutralizing Antibodies in Intravenous Immunoglobulins (PDF - 165 KB) - Susette Audet
- The United States Immunodeficiency Research Consortium - USIDNET (PDF - 38 KB) - Michael Blaese, MD
- Epidemiology of Serious Infections in Primary Immunodeficiency Diseases II (PDF - 353 KB) - Rebecca H. Buckley, MD
- Epidemiology of Serious Infections in PIDD (PDF - 878 KB) - Charlotte Cunningham-Rundles MD PhD
- Immune Responses in Clearance and Protection from Measles (PDF - 586 KB) - Diane E. Griffin, MD PhD
- The ESID Online Database (PDF - 801 KB) - Bodo Grimbacher, MD
- European Perspectives on IVIG Usage & Testing of IVIGs by the Paul-Ehrlich-Institute (PDF - 292 KB) - Steffen Gross, MD
- Studies on Antibody Titers of Grifols' IGIVs (PDF - 170 KB) - Grifols
- Immune Globulins for PIDD (PDF - 433 KB) - Thomas R. Kreil, PhD
- Antibody Levels in IGIV: Historical Data and Current Products (178 KB) - Peter Lerch
- Antibodies to Streptococcus pneumoniae and Haemophilus influenzae type B in U.S.-licensed IGIV (PDF - 93 KB) - Dorothy Scott, MD
- History and Rationale for Measles Antibody Testing in Immune Globulins (PDF - 74 KB) - Dorothy Scott, MD
- Epidemiology of Measles, Polio and Diphtheria United States (PDF - 410 KB) - Jane Seward, MBBS, MPH
- Measles Antibody Titers in Plasma Donors (PDF - 117 KB) - Toby L. Simon, MD
- Use of Antibody in Infectious Diseases (PDF - 332 KB) - E Richard Stiehm MD
- Additional Handout (PDF - 30 KB) - E Richard Stiehm MD
- Measles antibody levels in PIDD Patients (PDF - 76 KB) - Othmar Zenker, MD