Exploring Knowledge Management in the Pharmaceutical Industry –
A comprehensive E-supplement from ISPE
“An investment in knowledge pays the best interest.”
Since 2008 and the publication of ICH Q10, the importance of the role of knowledge management has been clearly positioned as one of two key enablers necessary for the successful implementation of an effective Pharmaceutical Quality System. In the intervening years, many organizations have engaged in earnest on their quest to manage the knowledge locked within.
Last November, at ISPE’s Annual Meeting in Washington, there was much buzz among the delegates about the publication in Pharmaceutical Engineering of a case study from Merck on their Knowledge Management (KM) evolution. While the global regulatory community have high level expectations for knowledge management, the industry is still grappling with how to deliver real programs that address the many complexities of capturing, converting and communicating the existing and emerging knowledge within their organizations. To address the issue, Pharmaceutical Engineering developed a dedicated electronic-supplement on knowledge management in the pharmaceutical industry.
There is a real need to for ISPE Members and the industry overall to share experiences, current practices, and practical resources. As an answer for this, Pharmaceutical Engineering is releasing its Knowledge Management E-Supplement with ten thought provoking contributions, including:
- KM approaches from Merck, Takeda and Roche
- Contributions from the international regulatory community (EU and Japan)
- Current thinking from leading service providers on the Long Tail of Knowledge, The Role of Taxonomies, and Documenting Process Knowledge
- Academic input on the role of tacit knowledge and the evolution of knowledge within the new regulatory paradigm
- A guide to the available ISPE PQLI knowledge resources
Much has been written in recent years about the knowledge continuum (data, information, understanding, knowledge, wisdom). Ultimately in our industry, wisdom lies in our ability to recognize the role that knowledge plays in enhancing our patient focused decision making capabilities - every batch every day.