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Embracing Knowledge Management in the Pharmaceutical Industries

Posted on April 8, 2015 by

Joe Brady, Director of Global Compliance and Validation

A common industry definition (Wikipedia) defines knowledge management (KM) as “… the process of capturing, developing, sharing, and effectively using organisational knowledge. It refers to a multi-disciplined approach to achieving organisational objectives by making the best use of knowledge.” Ever since the International Conference on Harmonisation (www.ich.org) identified, in their Q10 quality guideline (June 2008), both knowledge management and risk management as key-enablers and key tenets of a pharmaceutical quality system, industry has been exploring mechanisms and principles for their implementation ever since.

Zenith Technologies was one of the many attendees at the recent and prestigious ‘Knowledge Management’ conference held in the impressive surroundings of Dublin Castle. The two day event held on Thursday the 26th and Friday 27th March 2015 incorporated five keynote sessions, three industry insights, three breakout and moderated feedback sessions, multiple interactive panel discussions, one research session, and many networking opportunities over lunch and dinner gatherings. Regulatory Science Ireland, in conjunction with the Dublin Institute of Technology (DIT) and the Health Products Regulatory Authority (HPRA) in Ireland, ought to be highly commended and praised for an educational, informative, and well-organised and attended event. Zenith Technologies was honoured to sponsor the lanyards worn by all delegates at the conference.

Knowledge Management

It was obvious over the two day event that the pharmaceutical industry is keen and eager to continuously benchmark their fledging knowledge management activities against best practices currently seen in other industries worldwide. This was immediately evident with the conference kicking-off with an impressive presentation by Ed Hoffman, NASA’s Chief Knowledge Officer. Cindy Hubert from the American Productivity & Quality Centre (APQC) described how to enable flow of knowledge, and Mark Wolff at the SAS Institute described methods on how to extract useful knowledge from Web-based media sources for post-marketing surveillance.

Over the two day conference there were also impressive regulatory inputs with presentations from the Irish Health Products Regulatory Authority (HPRA), the French Health Products safety Agency (ANSM), the UK Medicines and Healthcare Products Regulatory Agency (MHRA), Swissmedic Regulatory Authority, and the European Medicines Agency (EMA). Excellent global case studies were provided by industry representatives from Amgen, Eli Lilly, MSD/Merck and Pfizer. The Irish Government’s Minster for Health, Leo Varadkar, took the time from his very busy schedule to close the first day’s proceedings with the traditional Irish ‘céad míle fáilte’ (a “hundred thousand welcomes”), and gave an inspiring address to the delegates of an overview of Ireland’s pharmaceutical manufacturing landscape and its global strategic importance.

During the breakout and moderated feedback sessions delegates greatly attempted to find a fitting definition for knowledge management as it would apply to the pharmaceutical industry. It is probably fair to say that at this time more work needs to be done to succinctly define an all-encompassing and relevant term. There was an impression during the regulatory presentations that there is a reluctance on the part of the global regulators to standardise and police knowledge management activities associated with the pharmaceutical industries.

With over seventeen years of experience, with more than four-hundred and seventy employees, and with a 95% client base in the pharmaceutical and medical device industries, Zenith Technologies have vast knowledge of process controls systems, manufacturing execution systems, validation and quality systems, in GxP regulated environments. Coupled with evolving expertise in risk management, Zenith Technologies are placing themselves in a position to facilitate, where appropriate, our clients’ knowledge management initiatives as they pertain to our core business. Zenith Technologies anticipates facilitating clients’ knowledge management initiatives now and in the future by the utilisation of technological business solutions, and the contribution of subject matter expertise based on extensive industry experience.

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