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DIA Presentations, Washington, DC, June 2004
Consumer Education
- Using the Web to Educate Consumers about Drugs, Carol S.
Cavanaugh, M.L.S., FDA. [HTML]
or [PPT]
Drug Safety
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Office of Drug Safety Update, Paul J. Seligman,
M.D., M.P.H., FDA. [HTML]
or [PPT]
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Division of Drug Risk Evaluation Update, Mark Avigan,
M.D. C.M., FDA [HTML] or [PPT]
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Office of Drug Safety Update, Gerald J. Dal Pan, M.D., MHS, FDA.
[HTML] or [PPT]
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The Role of MedDRA and SNOMED in the Evolving US
Healthcare Environment, Andrea Feight, FDA. [HTML]
or [PPT]
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E2B(M) FDA Perspective, Roger Goetsch, Pharm D.,
FDA. [HTML] or [PPT]
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Drug Naming Activities Update, Mary C. Gross, FDA.
[HTML] or [PPT]
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Division of Medication Errors and Technical Support,
Carol Holquist, RPh, FDA [HTML]
or [PPT]
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Communicating Risk to Patients: Labeling and Private
Sector Information, Karen Lechter, J.D., Ph.D., FDA. [HTML]
or [PPT]
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Communicating Science Clearly: Making Your Writing
Comprehensible to Your Reader, Karen Lechter, J.D., Ph.D., FDA. [HTML]
or [PPT]
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FDA MedWatch and Medication Safety -
Communicating Risk to Healthcare Professionals, Norman S. Marks,
M.D. [HTML] or [PPT]
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Risk Management Soup: Risk Minimization Action Plan
Tools, Toni Piazza-Hepp, Pharm.D., FDA. [HTML]
or [PPT]
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Identification of Safety Concerns, Judith A.
Racoosin, M.D., M.P.H., FDA. [HTML]
or [PPT]
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Examining Patterns of Long-Acting Opioid Drug Use:
Targeting Risk Management, Gianna C. Rigoni, Pharm.D., M.S., FDA.
[HTML] or [PPT]
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Convening Stakeholders/Building Partnerships: FDA
and the CERTs, Paul J. Seligman, M.D., M.P.H., FDA. [HTML]
or [PPT]
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PDUFA III Update on Drug Safely Guidances, Paul J.
Seligman, M.D., M.P.H., FDA. [HTML]
or [PPT]
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Phonetic Orthographic Computer Analysis (POCA)
System, R. F. Shangraw, Jr., Ph.D., Project Performance Corporation.
[PDF]
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How FDA Employs POCA, Denise P. Toyer, Pharm.D.,
FDA. [HTML] or [PPT]
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Standardized MedDRA Queries (SMQs): Search
Strategies, Communication, and Analyzing Results Using SMQs: A
Regulatory Perspective, Melissa M. Truffa, R.Ph. FDA. [HTML]
or [PPT]
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Cooperation in the Development of a Risk Management
Program, Mary Willy, PhD, FDA. [HTML]
or [PPT]
International Activities
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CTD Update, Justina A. Molzon, M.S. Pharm., J.D.,
FDA [HTML] or [PPT]
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Advantages of the CTD Clinical Section Format for
Regulatory Reviewers, Justina A. Molzon, M.S. Pharm., J.D., FDA [HTML]
or [PPT]
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The CTD One Year Later: Update on Status of
CTD Implementation, Justina A. Molzon, M.S. Pharm., J.D., FDA [HTML]
or [PPT]
Others from FDA
Staff (posted 7/22/2004)
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Abimbola Adebowale Ph.D., “Regulatory
Perspective of Exposure-Response (E-R) in OTC Drug Development” -
Office of Clinical Pharmacology and Biopharmaceutics [HTML]
or [PPT]
-
Silvia N. Calderon-Gutkind, Ph.D., “The
Assessment of Abuse Liability: What is all about?” [HTML]
or [PPT]
-
Jeri El-Hage, Ph.D., "Preclinical and
Clinical Safety Assessments for PPAR Agonists" [HTML]
or [PPT]
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Michael Folkendt, “Continuous Marketing
Applications (CMA) Pilot Programs” [HTML]
or [PPT]
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Richard L. Friedman, M.S., “Sterile Drugs:
The Benefits of Risk Analysis” - Office of Compliance [HTML]
or [PPT]
-
Martin D. Green, Ph.D., “Non-clinical
Studies: Does One Size Fit All?” [HTML]
or [PPT]
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David Hilfiker, “OTC Drugs Today and
Tomorrow” - Division of Over the Counter Drug Products [HTML]
or [PPT]
-
James Kaiser, M.D., “Investigator-sponsored
Investigational New Drug Applications (INDs)” [HTML]
or [PPT]
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Deborah B. Leiderman, M.D., M.A., “Abuse
Liability Assessment and Drug Dependence: Scientific and
Regulatory Considerations in Drug Development” [HTML]
or [PPT]
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Randy Levin, M.D., “Data Standards for
Regulated Clinical Trials: FDA Perspective” [HTML]
or [PPT]
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Randy Levin, M.D., “FDA Related Activities:
Structured Product Labeling Project for the DailyMed Initiative” [HTML]
or [PPT]
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Randy Levin, M.D, “Update on Electronic
Submissions Using eCTD Specifications: Submission Data Standards”
[HTML] or [PPT]
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Randy Levin, M.D., “JANUS Clinical Trials
Data Warehouse” [HTML]
or [PPT]
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Stella G. Machado, Ph.D., “Considerations On
Design And Analysis Of Clinical Trials For Assessing Qt
Prolongation” - Office of Biostatistics [HTML]
or [PPT]
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Joy Mele, “The NDA Clinical Study Report:
What a CDER Statistical Reviewer Looks For” - Office of
Biostatistics [HTML] or [PPT]
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Melodi J. McNeil, R.Ph., M.S., “Challenges of
Data Mining the FDA’s Adverse Event Reporting System (AERS)
Database” - Office of Pharmacoepidemiology and Statistical Science
[HTML] or [PPT]
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Steve Miller, Ph.D., “Update on Drug
Substance and Drug Product Draft Guidances” - Office of New Drug
Chemistry [HTML] or [PPT]
-
Thomas Papoian, Ph.D., D.A.B.T., “Standard
for Exchange of Nonclinical Data (SEND): FDA’s Perspective” -
Division of Cardio-Renal Drug Products [HTML]
or [PPT]
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Jane Scott, Ph.D. "Validation of Electronic
Patient Reported Outcomes (ePROs) -- an Endpoint Review
Perspective" [HTML] or [PPT]
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Jane Scott, Ph.D. "Regulatory
Perspective on Patient Reported Outcomes (PROs) as Primary
Endpoints" [HTML] or [PPT]
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Janice Soreth, “Target Product Profile (TPP)”
[HTML] or [PPT]
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Judy A. Staffa, Ph.D., R.Ph., “Drug
utilization data resources: Strengths and limitations of their use
in risk management” - Office of Drug Safety [HTML]
or [PPT]
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William B. Tauber, M.D., “Serious Adverse
Events Associated with use of the Anti-TNF alpha Drugs” - Division
of Therapeutic Biologic Internal Medicine Products [HTML]
or [PPT]
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Robert J. Temple, M.D., “Where Protocol
Design Has Been a Critical Factor in Success or Failure” [HTML]
or [PPT]
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Douglas C. Throckmorton, M.D., “Risk of QT
Interval Prolongation: Non-clinical and Clinical Evaluation” [HTML]
or [PPT]
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D. Christopher Watts, Ph.D., “Process
Analytical Technology (PAT): What’s in a name?” – Office of
Pharmaceutical Science [HTML]
or [PPT]
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Karen D. Weiss, M.D., “The Biological Pre-IND
Meeting” - Office of Drug Evaluation VI, [HTML]
or [PPT]
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Jonathan Wilkin, M.D. "An FDA Approach to the
Pre-IND Meeting Between a Sponsor and the Agency" [HTML]
or [PPT]
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Steve Wilson, DrPH, “Standard Data & eReview
Tools” [HTML] or [PPT]
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Steve Wilson, DrPH, “Statistical Analysis
Plans and Analysis Databases: Regulatory Perspectives” [HTML]
or [PPT]
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Steve Wilson, DrPH, “Guidance Compliant eCTDs:
Module 2: Summaries, Module 4: Safety” [HTML]
or [PPT]
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Steve Wilson, DrPH, “Submission of Analysis
Datasets: A Regulatory Perspective” [HTML]
or [PPT]
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Date created: June 29, 2004, Updated, July 22, 2004 |
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