By: Nuala Calnan, Regulatory Science Researcher, Dublin Institute of Technology

An investment in knowledge pays the best interest – Benjamin Franklin

Since 2008 and the publication of ICH Q10, the importance of the role of knowledge management has been clearly Knowledge Imagepositioned 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 article in Pharmaceutical Engineering on a case study from Merck on their Knowledge Management (KM) evolution.  In a meeting I had with Gloria Hall, Editor and Director of Publications at ISPE, we discussed the fact that while the regulators had set out their high- level expectations for knowledge management, the industry was 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.  The seed was sown for us to start work on a dedicated Pharmaceutical Engineering E-supplement on knowledge management in the pharmaceutical industry.  This supplement will be available for download in May.

As a researcher in the field of ICH Q8-Q11 implementation and longtime ISPE volunteer, I was happy to take on the task of ‘curating’ the supplement and set about seeking diverse inputs from regulators, industry, service providers and academia.  What I found was a real appetite for sharing experience, current practice and practical resources.  ISPE now brings to you ten thought provoking contributions on the subject of managing knowledge including:

  •  Three KM approaches from Merck, Takeda and Roche
  • Two contributions from the international regulatory community (EU and Japan)
  • Current thinking from leading service providers on the Long Tail of Knowledge (APQC), The Role of Taxonomies (SmartLogic) and Documenting Process Knowledge (CAI)
  • 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 and 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 in every batch, every day.

ISPE hopes that this supplement will invigorate an industry dialog on knowledge management.  We welcome your feedback and suggestions.