42nd Annual Meeting of the Drug Information Association, June 18-22, 2006, Philadelphia, PA

Program, 42nd Annual Meeting of the Drug Information Association, June 18-22, 2006, Philadelphia, PA [PDF]

Presentations ordered by Author's last name:  

• Alexander, John, Medical Team Leader, FDA Division of Anti-infective and Ophthalmology Products; Best Pharmaceuticals for Children Act BPCA: Pediatric Safety Review and the Medical Officer [PDF]
   
• Behrman, Rachel, MD, MPH, FDA Office of Medical Policy; The New Content and Format Requirements for Prescription Drug Labeling - Leaner, Cleaner, More Precise [PDF]
   
• Bass, Steven, PhD, Bristol-Myers Squibb, Burke, Laurie, RPh, MPH, FDA, Fava, Jamie, PharmD, Bristol-Myers Squibb; Prescription Drug Labeling: Implementation of FDA’s New Regulation for the Content and Format of the USPI and Accompanying Documents [PDF]
   
• Burke, Laurie, RPh, MPH, FDA, Rock, Edwin, MD, PhD, FDA, Powers, John, FACP, MD, FDA, Robert O’Neill, PhD, FDA; Patient-reported Outcome Instruments: Overview and Comments on the FDA Draft Guidance [PDF]
   
• Chen, Yeh-Fong, FDA Division of Biometrics; How Long Should Antidepressant Drugs be Continued to Prevent Relapse in Clinical trials? [PDF]
   
• Clark, Jon, MS, Associate Director, FDA Office of Pharmaceutical Science Policy Development; Briefing on Development of QMS for CDER and CBER [PDF]
   
• Collier, Bronwyn, BSN, Associate Director for Regulatory Affairs, FDA Center for Drug Evaluation and Research; eCTD: Module 1: From submission to reviewer [PDF]
   
• Cooper, Charles, Clinical Reviewer, FDA Office of Biostatistics; Use of New Tools for Safety Analysis [PDF]
   
• Cummins, Susan, MD, MPH, Executive Director, FDA Drug Safety Oversight Board; Drug Safety Oversight Board Update [PDF]
   
• Cummins, Susan, MD, MPH, Executive Director, FDA Drug Safety Oversight Board; Regulatory Affairs, DSB update; CDER Hot Topic-Update: Drug Safety Initiatives [PDF]
   
• Dal Pan, Gerald, MD, MHS, Director, FDA Office of Surveillance and Epidemiology; Office of Drug Safety Update [PDF]
   
• Dal Pan, Gerald, MD, MHS, Director, FDA Office of Surveillance and Epidemiology; Active Surveillance as a Post-marketing Drug Safety Tool [PDF]
   
• El-Hage, Jeri, PhD, Co-chair of Pharmacokinetics/Toxicokinetics Committee, Supervisory Pharmacologist, Division of Metabolism and Endocrinology Products; Safety Testing of Drug Metabolites [PDF]
   
• El-Hage, Jeri, PhD, Supervisory Pharmacologist, Division of Metabolism and Endocrinology Products; Peroxisome Proliferator-Activated Receptor (PPAR) Agonists: Preclinical and Clinical Cardiac Safety Considerations [PDF]
   
• Famulare, Joseph, Acting Deputy Director, FDA Office of Compliance; FDA CDER Compliance Initiatives [PDF]
   
• Gensinger, Gary, MBA, Director, Regulatory Review Support Staff, Office of Business Process Support; Standards and Successful Document Creation [PDF]
   
• Goodman, Vicki, MD, FDA Office of Oncology Drug Products; FDA Perspective on Innovative Trial Designs in Oncology [PDF]
   
• Goodsaid, Federico, PhD, FDA Office of Clinical Pharmacology; FDA-EMEA Joint Session on Emerging Therapies and Technologies [PDF]
   
• Goodsaid, Federico, PhD, FDA Office of Clinical Pharmacology; Joint USFDA-EU Pharmacogenomic Initiatives [PDF]
   
• Green, Lanh, Pharm D, MPH, FDA Office of Surveillance and Epidemiology; Postmarketing Pharmacovigilance Practice at FDA [PDF]
   
• Jansen, Deborah, Center Lab Quality Manager, FDA Center for Biologics Evaluation and Research; What Do You Mean When You Say Quality System? [PDF]
   
• Justice, Robert, MD, MS, FDA Division of Drug Oncology Products; How FDA Will Work with Sponsors to Accelerate Oncology Drug Development in the Era of Critical Path [PDF]
   
• Karwoski, Claudia, Pharm D, Scientific Coordinator for Risk Management, FDA Office of Surveillance and Epidemiology; Practical Experience with Risk Management Plans in the US [PDF]
   
• LoCicero, Colleen, RPh, Associate Director for Regulatory Affairs, FDA Office of Drug Evaluation I; Labeling for Human Prescription Drug and Biological Products – Implementing the New Content and Format Requirements (“Implementation Guidance”) [PDF]
   
• Molzon, Justina, MS, Pharm, JD, Associate Director for International Programs, FDA Center for Drug Evaluation and Research; ISS/ISE: Where Do They Fit in the CTD/eCTD? [PDF]
   
• Murray, Jeff, MD, MPH, Deputy Director, Division of Antiviral Products; Clinical Perspective of Endpoint Selection for HIV Clinical Trials in Treatment-Experienced Populations [PDF]
   
• Oliva, Armando, MD, Associate Director for Policy, FDA Office of New Drugs; ISE/ISS Analyses: Clarity in a CTD or eCTD – Clinical Reviewer Perspective [PDF]
   
• Pauls, Lana, MPH, Director, FDA Quality Management Staff; QMS: The Impact on Drug Safety Process Improvement [PDF]
   
• Pauls, Lana, MPH, Director, FDA Quality Management Staff; The Quality System (QS) Train is Moving Fast at FDA [PDF]
   
• Phelan, Kathleen, R Ph, Safety Evaluator, FDA Office of Surveillance and Epidemiology; Pediatric Postmarketing Safety Reviews: Methods and Findings [PDF]
   
• Rock, Edwin, MD, PhD, FDA Office of Oncology Drug Products; Regulatory Considerations [PDF]
   
• Seligman, Paul, MD, MPH, Associate Director for Safety Policy and Communication, FDA Center for Drug Evaluation and Research; CDER Hot Topics Drug Safety Update [PDF]
   
• Shapiro, Alan, MD, PhD, Medical Officer, FDA Division of Pediatric Drug Development; Implementation of the Best Pharmaceuticals for Children Act: the FDA Pediatric Post-Marketing Safety Review Experience [PDF]
   
• Stockbridge, Norman, FDA Office of New Drugs; A Modest Proposal for a Simple Trial Designer [PDF]
   
• Temple, Robert, MD, Associate Director for Medical Policy, FDA Center for Drug Evaluation and Research; CTD – ISS/ISE Introduction and Summary of Issues [PDF]
   
• Unger, Ellis, MD, FDA Office of New Drugs; Background and Overview of the CIOMS VII Project: The DSUR [PDF]
   
• Vaccari, Leslie, BSN, RAC, Project Management Officer, FDA Botanical Review Team; Current Regulation of Botanical Drugs in the United States [PDF]
   
• Ventura, Virginia, Regulatory Information Specialist, FDA Office of Business Process Support; Guidance Compliant eCTDs Module 2: Summaries [PDF]
   
• Ventura, Virginia, Regulatory Information Specialist, FDA Office of Business Process Support; eSUBS and eCTDs: Practical Advice and Pitfalls to Avoid [PDF]
   
• Yu, Lawrence, PhD, Director for Science, FDA Office of Generic Drugs; Implementation of Quality-by-Design: Question-based Review [PDF]
   
• Zhou, Feng, Statistician, FDA; Stephan Wilson, Division Director, FDA; A Statistical Reviewer's Perspective [PDF]