Since the International Conference on Harmonisation identified in their Q10 quality guideline (June 2008) knowledge and risk management as key enablers and tenets of a pharmaceutical quality system, the industry has been exploring mechanisms and principles for their implementation.
Zenith Technologies was one of the attendees at the recent Knowledge Management conference held in Dublin Castle.
The two day event, held on 26 and 27 March incorporated five keynote sessions, three industry insights, three breakout and moderated feedback sessions, multiple interactive panel discussions, one research session and networking opportunities.
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.
Over the two day event, attendees were keen to continuously benchmark knowledge management activities against best practices currently seen in other industries worldwide for the pharmaceutical sector.
This was evident with the conference starting with a presentation by NASA’s chief knowledge officer Ed Hoffman.
Cindy Hubert from the American Productivity and 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 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).
Global case studies were provided by industry representatives from Amgen, Eli Lilly, MSD/Merck and Pfizer.
Irish minister for health Leo Varadkar closed the first day’s proceedings with the traditional Irish ‘céad míle fáilte’ (‘a hundred thousand welcomes’), and gave an 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 attempted to find a fitting definition for knowledge management as it would apply to the pharmaceutical industry.
At this time, more work needs to be done to define this 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.