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DIA Presentations, Washington,
DC, June 2005
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Key: PDF = Adobe Acrobat file; PPT = Microsoft Powerpoint file
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Program, 41st Annual Meeting of the Drug Information
Association, June 26-30, 2005, Washington DC [PDF] Presentations ordered by Author's last name:
- Julie Beitz, MD, Deputy Director, Office of Drug
Evaluation III.Guidance for Industry: Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment. [PDF]
or [PPT]
- Allen Brinker, MD, Medical Epidemiologist, Division
of Drug Risk Evaluation, Office of Drug Safety. Perspectives In
The Planning And Implementation of Registries. [PDF]
or [PPT]
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Laurie B. Burke, RPh, MPH, Director, Study Endpoints and
Label Development, Office of New Drugs. TPP Practical Implementation: An FDA Perspective. [PDF]
or [PPT]
- Ling Chen, Ph.D., Quantitative Methods and Research
Staff, OB/CDER/FDA. Statistical Considerations in Design and Analysis of
Drug Abuse Clinical Trials. [PDF]
or [PPT]
- Ramzi Dagher,
MD, DODP/CDER/FDA. FDA Oncology: A Partner in Innovation. [PDF]
or [PPT]
- Karen Davis-Bruno; Ph.D. Pharmacology Toxicology
Coordinating Committee, Pediatric Working Group. FDA/CDER Perspective on Juvenile Animal Studies for
Safety Assessment of Pediatric Drugs. [PDF]
or [PPT]
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Jeanne M. Delasko, FDA; Sharon N. Olmstead, Schering Plough;
Linda
S. Carter, Johnson & Johnson. FDA Labeling Update Target Product Profile (TPP). [PDF]
or [PPT]
- Joseph C. Famulare, Director, Division of
Manufacturing and Product Quality, Office of Compliance, CDER. Update on Compliance CGMP Initiatives. [PDF]
or [PPT]
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Lesley R. Frank, Ph.D., J.D., FDA-DDMAC. Advertising: Regulatory Primer Course Overview. [PDF]
or [PPT]
- Richard L. Friedman, Center for Drug Evaluation &
Research, Office of Compliance, Division of Manufacturing &
Product Quality. Continuous Improvement under Modern Quality Systems
and CGMPs.
[PDF]
or [PPT]
- Kathleen Fritsch, Ph.D., Biostatistics Reviewer, FDA/CDER;
Mohamed Alosh, Ph.D., Biostatistics Team Leader,
FDA/CDER. Study Design Issues in Prevention Trials. [PDF]
or [PPT]
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Felix W. Frueh, PhD, Associate Director for Genomics, Office of
Clinical Pharmacology and Biopharmaceutics, CDER/FDA. Voluntary Genomic Data Submissions: One Year Later. [PDF]
or [PPT]
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H.M. James Hung, Division of Biometrics I, OB/CDER/ FDA. A Regulatory Perspective on Adaptive Randomization, [PDF]
or [PPT]
- David Jacobson-Kram, Ph.D., DABT, Office of
New Drugs. Evolution in Regulatory Guidance for Drug Candidates
that are Negative for Bacterial Mutation and In vivo Clastogenesis
but Positive in an In vitro Mammalian Cell Assay: The In vitro
Clastogen Conundrum .
[PDF]
or [PPT]
- Michael Klein, Ph.D., Controlled Substance Staff
CDER/FDA. Objectives of a Drug Abuse Potential, Human
Laboratory Study.
[PDF]
or [PPT]
- Lisa
Mathis, M.D., Acting Director, Division of Pediatric Drug
Development. Pediatric Drug Development: BPCA and PREA.
[PDF]
or [PPT]
- Susan K. McCune, M.D., M.A.Ed., Medical Officer,
Division of Pediatric Drug Development, Office of
Counter-Terrorism and Pediatrics. Creative Clinical Trials for Pediatric Drug
Development. [PDF]
or [PPT]
- Grace E.
McNally, CDER Office of Compliance, Division of
Manufacturing & Product Quality. Lifecycle Approach to Process Validation. [PDF]
or [PPT]
- Robert J.
Meyer, MD, Director, ODE II /OND/CDER, Chair of RA
Working Group. The Premarketing Risk Assessment Guidance. [PDF]
or [PPT]
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Andrew D. Mosholder, M.D., M.P.H., Medical Officer, FDA
Office of Drug Safety. Antidepressant Use in Children and Adolescents. [PDF]
or [PPT]
- Stephan
Ortiz, R.Ph., Ph.D., Office of Clinical Pharmacology and
Biopharmaceutics, FDA. Vasomotor Symptom Dose-Response Modeling. [PDF]
or [PPT]
- Thomas Papoian, Ph.D.,
D.A.B.T., Senior Pharmacologist/Toxicologist, Division of
Cardio-Renal Drug Products, CDER/FDA. Attenuation of Ventricular Remodeling Associated
with Heart Failure in an Animal Model: Use of Microarray Data in
Support of a Hypothetical Drug Submission [PDF]
or [PPT]
- Thomas Papoian, Ph.D., D.A.B.T., Senior
Pharmacologist/ Toxicologist, Division of Cardio-Renal Drug
Products. Standard for Exchange of Nonclinical Data (SEND):
Past, Present and Future. [PDF]
or [PPT]
- Curtis J. Rosebraugh, MD, MPH, Deputy Director OTC
Drug Products, FDA. FDA Perspective on OTC Switching. [PDF]
or [PPT]
- Daniel Shames, MD, FACS;
Jerry
Willett, MD; Stephan Ortiz, R.Ph, PhD. Application of Critical Path Principles to the
Development of Drugs for Menopausal Symptom Therapy (MST) after the
Women’s Health Initiative (WHI). [PDF]
or [PPT]
- Daniel Shames, MD, FACS. A Clinical Trial Endpoint Case. [PDF]
or [PPT]
- Daniel Shames, MD, FACS, Director, DRUDP. Dealing with WHI from Inside the FDA: Advancement of
Risk Communication.
[PDF]
or [PPT]
- Lisa
Stockbridge. Structured Product Labeling at FDA. [PDF]
or [PPT]
- Lisa
Stockbridge.Structured Product Labeling at FDA. [PDF]
or [PPT]
- Leslie A. Vaccari, BSN, RAC, Project Management
Officer, Botanical Review Team, ODE I, Office of New Drugs. Botanical Drugs Update. [PDF]
or [PPT]
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Date created: August 19, 2005 |
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