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ICH Q10 knowledge management

The efficient handling of information and resources is key for achieving success within a commercial organisation. Against the backdrop of ICH Q10 – the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Christian Rack discusses five things you can implement right now to improve your company’s knowledge management and break down the barriers to knowledge sharing.

THERE IS an important saying that states: “Information damages only the person who does not have it.” Despite this, or maybe because of it, structured knowledge sharing leaves room for improvement in many companies. From the two enablers in the ICH Q10 guidelines – risk and knowledge management – knowledge management plays a secondary role. In contrast to risk management, according to ICH Q9, there is no clear guidance about what a structured knowledge management process should look like.1 For various reasons, people tend not to share the knowledge they have; for example, due to scattered physical locations and the usage of knowledge as power.2 Hoarding of knowledge is, if not otherwise organised, beneficial for its owner and risky for the organisation.3 However, effective knowledge management is seen as a competitive advantage and fundamental for generating new ideas.4

Effective knowledge management requires an interplay of areas: people, processes, content and technology.5 People must be willing to share their knowledge and this works best if it is supported by a corresponding corporate culture, rewards system and is assigned key roles.6 Processes describe the workflow from knowledge acquisition to knowledge sharing and application.7 Content describes the knowledge sources that should be made available. These could be internal, explicit or tacit knowledge.8 The active screening of external knowledge is often not directly associated with knowledge management, but rather with the term regulatory intelligence.9 The last area covers technological aspects including the taxonomy, visualisation tools or document management.10











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