Master's Course "Drug Regulatory Affairs"

Study Modules

Modul 06 (WS 2017 / SS 2018)

Information management, eCTD

attendance approx. Seminar Paper Method of examination Credit
approx. 20 h approx. 20 h practical task 3

Module Supervisor

  • Wolfgang Witzel, Frankfurt am Main

Topics

The internet
  • Requirements for use, functional description
  • Internet services
  • Research on the internet (catalogs, search engines, meta search engines, search options and search functions)
  • Validity of information on the internet (criteria, trust information)
  • Useful websides for regulatory affairs
Scientific databases
  • Definitions, database types, docuuments, data fields, search terms thesaurus
  • Database offers and access options
  • Security requirements
  • User interfaces (command language, graphic user interfaces)
  • Search strategy and search logic
  • Supplementary functions

The information systems of the German Institute for Medical Documentation and Information (DIMDI)

  • Information system for medicinal products
  • Information systems for healthcare economic evaluation
  • Classification system of the WHO
  • Information system for pharmaceuticals
  • AMIS database: structure and scope, modules, search options, data fields
Document management at the authorities
  • Organization of regulatorory documents (CTD)
  • Papier vs. electronic documentation
  • Document management system (structure, functions, authenticity, version management)
  • Project management / work organization for converting to electronic documentation
  • File formats (XML, XLS, DTD)
  • Official requirements for the electronic marketing authorization application
  • International aspects of electronic marketing authorization┬Ě Submission Directive and its implications
  • Electronic signatures
Document management in the industry
  • Papier vs. electronic documentation
  • Implementation of an electronic document management system (organization, training, standardization)
  • Electronic submission (background, international regulations)
  • ICH M2 ESTRI / eCTD
Document management systems (taking DOKUMENTUM as an example)
  • Applications of document management systems and data/information flow in the life cycle of a pharmaceutical
  • Various document management systems
  • Criteria for slecting a document management system
  • Implementation of a document management system (aims, procedures, parties involved, schedule)

Study plan

Thursday   01 March 2018 from 8.30 a.m. - 6.30 p.m.
Friday   02 March 2018 from 8.30 a.m. - 6.30 p.m.
Saturday   03 March 2018 from 8.30 a.m. - 6.30 p.m.
Sunday   04 March 2018 from 8.30 a.m. - 2.00 p.m. (practical task)
Location:   Pharmaceutical Institute Bonn-Endenich

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