Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Development of a database concept for tracking and maintaining regional/country specific Product Information (PI) and PI requirements

Dr. Christian Wrehlke (Abschlußjahr: 2011)

Language: English

This Master Thesis describes a database concept how to retrieve reference documents like Company Core Data Sheets (CCDS) and agreed, approved or notified National Product Information (NPI) documents as well as accompanying documents from different databases and how to track and maintain regulatory Product Information (PI) documents and PI related information in a database system for regional and country specific needs.

The PI database concept consist of two parts, the first part describes how to handle PI documents and the other part how to set up recommendations and requirements to handle regulatory PI information as a knowledge source.
This PI database concept describes single data fields which are necessary for gathering related information covering the following main categories:

  • Related Product Description of a pharmaceutical product
  • Tracking of dispatch information of PI documents from HQ to affiliates as well as the submission to Authorities by the affiliates, to cover the duration of the dispatch to affiliates and the submission to Authority and Authority approval
  • Product Information documents and related information on PI content to define minimum Core Safety Information (CSI) requirements and additional local PI requirements
  • Regulatory Intelligence Information (information on legislation and regulation) for maintaining PI specific regulations and guidelines from specific regions or countries as a regulatory knowledge source


as well as

  • Additional Requirements to standardize regulatory requirements for clustering countries according to the PI requirements and content (e.g. Certificates of Pharmaceutical Product (CPP), separate or combined PI for healthcare professionals and patients, multi language packs)


In addition, this Master Thesis addresses the recommendations and requirements how to implement this PI database concept in the company.

Pages: 89,
Annexes: pages: 17

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