Method of examination: Course work or practical task
Credit points: 3 

Module Head: Prof. Dr. Harald G. Schweim, Wolfgang Witzel 

	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· 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)