CDER/CBER Risk Management 
Public Workshop

The Food and Drug Administration is announcing a public workshop to discuss risk management activities for drug and biologic products (excluding blood products other than plasma derivatives). The purpose of the workshop is to present FDA's current thoughts on risk management activities and to solicit views from the public. FDA is issuing three concept papers for discussion on risk assessment, risk management, and pharmacovigilance, which can be accessed below.

The public workshop will be held on April 9, 10, and 11, 2003, from 8:00 a.m. to 4:30 p.m. at the National Transportation Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza, SW, Washington, DC 20594. 

Preregistration is required only for those individuals that would like to make oral presentations. Please see the Federal Register Notice for preregistration instructions.

FDA is reopening until May 30, 2003, the comment period for three concept papers entitled ``Premarketing Risk Assessment,'' ``Risk Management Programs,'' and ``Risk Assessment of Observational Data: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.''  Federal Register Notice ( 5/12/2003)

Agendas  

• Risk Assessment, April 9, 2003 

• Risk Management, April 10, 2003  

• Pharmacovigilance, April 11, 2003  

Transcripts   

• April 9, 2003 Meeting Transcript (WORD)

• April 10, 2003 Meeting Transcript (WORD)

• April 11, 2003 Meeting Transcript (WORD)

Concept Papers

• Premarketing Risk Assessment

• Risk Management Programs

• Risk Assessment of Observational Data: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

• Risk Assessment, April 9, 2003

  • Risk Management Public Workshop, Deborah Henderson, Director, Office of Executive Programs, CDER
  • Premarketing Risk Assessment, Robert Meyer, M.D., Director, Office of Drug Evaluation II, CDER
  • Observations on Concept Paper I:  Pre marketing Risk Assessment, Glenn Gormley, M.D., Ph.D., AtraZenaca, PhRMA
  • International scientific forum for epidemiologists and safety experts working in regulatory, academic, and industry: Comments From The International Society for Pharmacoepidemiology, Judith Jones, M.D. Ph.D., The Degge Group, ISP
  • Premarketing Risk Assessment Special Conditions, Robert Temple, M.D., Director, Office of Drug Evaluation I, CDER
  • Statement made by Dr. Gary Stein, American Society of Health-System Pharmacists
  • Application of Safety Principles to Labeling, Packaging and Nomenclature Decisions, Michael Cohen, RPh, MS, ScD, Institute of Safe Medication Practices
  • Changing the Paradigm for Risk Assessment, Penelope K. Manasco, M.D. First Genetic Trust
  • Causality Assessment in Postmarketing Adverse Events, Anshu Vashishtha, M.D., Ph.D., Watson Pharmaceuticals
  • Premarketing Risk Assessment:  Considerations for Data Analysis and Data Presentation, Dr. Ellis Unger, Division of Clinical Trial Design and Analysis, CBER
  • Points to Consider:  Data Collection and Analysis, Christy Chaung-Stein, Ph.D., Pharmaceia, PhRMA
  • Biotechnology Industry Organization (BIO), Joanna Haas, M.D., Genzyme
  • Comments on FDA Concept Paper:  Premarketing Risk Assessment, Dr. Sidney Kahn, Pharmacovigilance & Risk Management, Inc.
  • Statement made by Dr. Paul Stolley, Public Citizen Health Research Group
    
    
• Risk Management, April 10, 2003
  • Risk Management Public Workshops, Dr. Paul Seligman, Director, Office of Pharmacoepidemiology and Statistical Science, CDER
  • Concept Paper on Risk Management Programs: FDA Presentations (Morning Session), Dr. Anne Trontell (CDER), Dr. Robert Wise (CBER), and Dr. Toni Piazza-Hepp, (CDER)
  • Risk Management Programs and Planning: FDA Risk Management Programs Concept Paper: A Pharmacist’s Perspective, Thomas Menighan, American Pharmaceutical Association
  • Day 2 - Risk Management Programs, Susana Perez-Gutthann, M.D. Ph.D., MPH, ISP
  • Statement by Gary Stein, Ph.D., American Society of Health-System Pharmacists
  • Statement on Risk Management of Prescription Drugs, Kim Swiger, RPh, National Association of Chain Drug Stores (Ukrops Super Markets, Inc.)
  • Concepts of Risk Management, When is a RMP Appropriate, and Risk Management Tools, Janice Bush, M.D., PhRMA
  • Anshe Vashishtha, M.D., Ph.D., Waton Pharmaceuticals
  • Evaluation Processes and Methods: FDA Presentations (Afternoon Session), Dr. Anne Trontell (CDER) and Dr. Claudia Karwoski (CDER)
  • Evaluation of Risk Management Programs and Recommended Elements of a Risk Management Program Submission, Gretchen Dieck, Ph.D., PhRMA
  • Comments on FDA Concept Paper:  Risk Management Programs, Sidney Kahn, M.D. Pharmacovigilance & Risk Management, Inc.
  • Comments on FDA's Risk Management Concept Paper,  Gerald Faich, M.D., MPH, Pharmaceutical Safety Assessments
  • Risk Management Workshop, Day #2, Robert Nelson, Ph.D., Quantitative Data Sources
  • ISPOR Comments to the FDA Concept Paper:  Risk Management Programs
    Marilyn Dix Smith, RPh, Ph.D., International Society for Pharmacoeconomics and Outcomes
    
    
• Pharmacovigilance, April 11, 2003
  • Risk Management Public Workshops, Dr. Steven Galson, Deputy Director, CDER
  • Risk Assessment of Observational Data: Good Pharmacovigilance Practices
    and Pharmacoepidemiologic Assessment, Dr. Julie Beitz, Deputy Director, Office of Drug Evaluation III, CDER
  • Good Pharmacovigilance Practices, Min Chen, RPh, Associate Director, Division of Drug Risk Evaluation, CDER
  • FDA Risk Management Workshop: Day #3, Robert C. Nelson, Ph.D., RCN Associates Inc.
  • Risk Assessment of Observational Data:  Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,  Stephen Goldman, MD, Stephen A. Goldman Consulting Services, LLC
  • Comments on FDA’s Pharmacovigilance and Pharmacoepidemiologic Assessment Concepts, Gerald Faich, MD, MPH, Pharmaceutical Safety Assessments
  • Causality Assessment in postmarketing adverse events, Anshu Vashishtha, MD, Ph.D., Watson Pharmaceuticals 
  • Introduction to Electronic Data Collection Methods; Improving Data Quality and Integrity in EpidemiologicalSafety Studies and Patient Registries, Gregory Gogates, CRF Box Inc.
  • Concept Paper #3:  Risk Assessment of Observational Data - Session 2: Pharmacoepidemiologic Assessment, Wendy Stephenson, PhRMA
  • Concept Paper #3:  Risk Assessment of Observational Data  Session 1: Good Pharmacovigilance Practices, Linda Hostelley, PhRMA
  • Pharmacoepidemiologic Assessment, Judy Staffa, Ph.D., RPh, Epidemiology Team Leader, Division of Surveillance, Research and Communication Support, CDER
  • Comments on FDA Concept Paper: Risk Assessment of Observational Data, Sidney Kahn, MD, Pharmacovigilance & Risk Management Inc.
  • International scientific forum for epidemiologists and safety experts working
    in regulatory, academia, and industry, Annette Stemhagen, DrPH, ISPE Membership Committee
    
    
• Other Presentations
  • FDA Perspective on Risk Management and Pharmacovigilance, Steven K. Galson, M.D., M.P.H, Deputy Director, CDER, Science and Regulatory Affairs Section Annual Meeting, May 4, 2003

Docket No. 02N-0528, CDER 200311. Risk Management; Public Workshop 
[TXT] [PDF]

For further information regarding this workshop, please contact Lee Lemley, Center for Drug Evaluation and Research, 301-594-6218, lemleyl@cder.fda.gov or for media questions contact Jason Brodsky, FDA Office of Public Affairs, 301-827-6242, jbrodsky@oc.fda.gov.