Regulatory Science Ireland (RSI)*

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The Regulatory Science Ireland (RSI) has offered the following Knowledge Management education and training opportunities:


  • Apr 2019: An Audience with Pharmaceutical Regulators, Academia and Industry: The role of Effective Quality Risk Management & Knowledge Management in Product Realization for Patients in the 21st Century
    (Organizer: School of Chemistry & Pharmaceutical Sciences, Dublin Institute of Technology; with: Health Products Regulatory Authority; Regulatory Science Ireland)
  • Oct 2018: An Audience with International Regulators in the Manufacture of Medicines: Quality Risk Management (QRM) and Knowledge Management (KM)
    (Organizer: School of Chemistry & Pharmaceutical Sciences, Dublin Institute of Technology; with: Regulatory Science Ireland; Health Products Regulatory Authority)


  • Knowledge Management Dublin (KM Dublin 2015), 26-27 March 2015, Dublin, Ireland
    Symposium Theme: Knowledge Management: From Discovery to Patient – Enabling Knowledge Flow, Delivering Safe & Effective Products
    (Co-organizers: Pharmaceutical Regulatory Science Team, School of Chemistry & Pharmaceutical Sciences, Dublin Institute of Technology; Health Products Regulatory Authority)

      The Knowledge Management Dublin 2015 (KM Dublin 2015) symposium will be the first of its kind in this rapidly emerging area of integrating knowledge management and risk management in the development, manufacture, surveillance and regulation of pharmaceutical and medical device related health products.

      The event will bring together thought leaders, health product regulators, life science industry practitioners and academics to explore the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients.

      Regulatory Science Ireland: Health Products Ireland’s response to the global Regulatory Science effort (welcome address)
      Integrating Knowledge Management and Risk Management: Lessons from NASA
      Knowledge as an Enabler for the Pharmaceutical Quality System
      Challenges in Knowledge Sharing
      Creating a successfull KM capability – A leaders responsibility (closing Session)
      The New Edge in Knowledge: Enabling flow (opening address)
      The Future of Regulatory Science (closing addrtess)

      Breakout Tracks (Sessions): Have Your Say, incl. moderated feedback session
      Building a Culture of Knowledge Sharing (What is Knowledge? Towards a Taxonomy; Approaches to steward organizational knowledge sharing; Leveraging the tacit knowledge in your organisation)
      Achieving Knowledge Flow (What is Knowledge? Towards a Taxonomy; Process and Product Knowledge – Identification and retention strategies; How do you overcome challenges in Knowledge Flow?)
      Managing Knowledge in the Digital Age (What is Knowledge? Towards a Taxonomy; Mining Insights from the Web? Dealing with issues of veracity when mining web based knowledge; Leveraging your Current Technology Tools to Drive more Effective KM)
      MedTech/ CRO /CMO’s (What is Knowledge? Towards a Taxonomy; Managing Knowledge Challenges in MedTech; Using your knowledge to improve future project outcomes)

      Panel Discussions:
      Beyond ICH Q10: Enhanced Risk Management through Knowledge Management
      Outcomes from the KM sessions with ICH Q12 Team Members

      Research Sessions:
      KM – The Orphan Enabler: Protecting the Patient through Effective Use of Knowledge

      Industry Insights:
      Enhancing Post-Marketing Surveillance: An Analysis of Self-Reported Health Outcomes and Safety Data from Web-Based Media Sources’ for FDA/CDRH
      A Practical Approach to Managing Knowledge – a Case Study in Merck Manufacturing
      Pfizer’s Journey to knowledge utilization and leveraging KM for Product and Process Understanding
      Management of Knowledge from a CRO perspective
      Applying Knowledge at SwissMedic (regulatory insight)

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