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The first joint CDER/CBER Pharmaceutical Industry Workshop -- in cooperation with the Drug Information Association (DIA) held November 6-7, 1996

Presentations

Presentations from the DIA-FDA meeting by CDER staff have been made available in HTML formats, as well as the orginal presentation format. If you are having problems reading .ppt files directly, right-click to download them. You can then read the file(s) with PowerPoint. There is a free PowerPoint viewer for Windows 95 at Microsoft.

  1. Agency Perspective on Electronic Submissions or PowerPoint Version : David Isom, Special Assistant to the Center Director (12/9/96)
  2. Case Report Forms (HTML) or PowerPoint Version : Karen Weiss, M.D. Center for Biologics
  3. Data Modeling and Building the Electronic KnowledgeBase for Regulatory Decision or PowerPoint Version : Steve Wilson Team Leader, Biometrics II (12/9/96)
  4. Electronic Case Report Forms File Formats (HTML) : Ken Edmunds, Division of Information Systems Design
  5. Electronic Case Report Tabulations -- Facilitating the Review Process (HTML): Brad Leissa, M.D., Div. of Anti-Infective Drug Products Office of Drug Evaluation IV
  6. Electronic Data Capture into e-Case Report Forms (Acrobat Format) PDF Document : Jeff Smith, CBER
  7. Proposed Interim Guidance for e-Submission of Case Report Forms and Tabulations or PowerPoint Version : Kathryn Zoon, PhD. Director-CBER
  8. Role of CRFs/CRTs in the Review Process (HTML): Renata Albrecht, M.D. Division of Anti-Infective Drug Products ODE IV, CDER

 

PDF requires the free Adobe Acrobat Reader

 

Date created: December 13, 1996; last update: July 11, 2005

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