One Module to Many Submissions: Generating Global Marketing Authorization Applications
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ONE MODULE TO MANY SUBMISSIONS: GENERATING GLOBAL MARKETING AUTHORIZATION APPLICATIONS DONNAMORGANMURRAY,PHD New Drug Development
SUSANM . DANSEREAU, JUDITH A. REILMAN, BA,
P H D , DONNAR. PARK,MA, AND BARBARA R. SNYDER, MA
Regulatory Services Department Procter & Gamble Pharmaceuticals. Inc., Cincinnati, Ohio
Procter & Gamble Pharmaceuticals is using Documentum ’s Workspace application and Xerox’s Document Assembler (XDA)application to assemble, publish, and produce global marketing authorization applications (MAAs). A modular approach is used to define the components of MAAs, using one module across regional applications whenever possible. Standards exist for each module so thot format and content expectations are met. Based on the table of contents needed for each MAA, modules are sorted into a virtual document created in Documentum Workspace. Publishing results in portable document format (PDF)files that are used for production of electronic submissions and paper volumes (printed via Xerox DocuTech printers): tables of contents specific to each regional submission; hyper-text links f o r cross-references and table of content entries in PDFs; and volume and page numbers f o r cross-references and table of content entries in paper volumes. MAAs were successfully assembled and published f o r two new drug products using these tools. Key Words: Documentum Workspace; Xerox Document Assembler; Marketing authorization applications; Electronic publishing; Document standards
INTRODUCTION LIKE MOST OF THE pharmaceutical industry, Procter & Gamble Pharmaceuticals (P&GP) was once rooted in a paper-based model for regulatory submissions, that is, our processes and standards were geared toward writing, reviewing, and archiving paper doc-
Some of the material in this manuscript was presented at the DIA’s “Annual Electronic Document Management Meetings” in 1997, 1998, and 2000. Reprint address: DM Murray, 5 Clarke court, Glendale, OH 45246.
uments. In addition, we were able to focus on only one submission at a time. Generally, this meant building a New Drug Application (NDA) or Biologics License Application (BLA) for the United States Food & Drug Administration (FDA) and then shipping the submission to our colleagues in other countries, who would rearrange, delete, and rewrite pieces to create the marketing authorization application (MAA) for their specific regulatory agencies. The Regulatory Services Department at P&GP has been moving from this Paperbased model to an electronic paradigm. In
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D. Morgan Murray, S.M . Dansereau, D. R. Park, J. A. Reilman, and B. R. Snyder
this new paradigm, which is based on a modular approach to generating submission documentation, electronic tools allow us to: 1. Generate, review, and archive documents and create an electronic global dossier (the total documentation required to meet global MAA requirements) during the dr
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