Experiences from building a lessons- learned database for regulatory interactions Åsa Rembratt Sr Reg Intelligence Manager Novo Nordisk A/S 26th Annual EuroMeeting March 2014 ACV, Vienna Austria

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The RAIL project RAIL = Regulatory Agency Interaction Learnings A lessons-learned database Purpose: To capture and make available new knowledge obtained during agency interactions Target: To optimise knowledge sharing across projects and products in the regulatory organisation and thereby increase the value of efforts made in the regulatory organisation

Topics adressed Input – Timeliness – Quality Content – Granularity – Relevance Output – Access – Searchability Lessons learned database FDA doesn’t want… EMA require… …which enabled submission. Useful info for you Useful info for project X Useful info for me

When is a lessons-learned database a success? When people use it to find information, repeatedly!

Output principles 6

System perception 7

Output, practical solutions 8

Input, timing 9 Sooner… Fresh perspectives Fast access for the organisation to new learnings …or later Time to digest Better knowledge on actual impact on project Goal: Within a month of the minutes/meeting.

Input, quality 10 What to share? Of interest to more than one project Not easily accessible from other sources (guidelines etc.) Quality aspects Correct & consistent level of detail Brief Understandable What if everybody knew but us? This is too project specific!

Ensuring input timeliness & quality 3 rd try 1st try Project champion Entry sparring partner Entry review & approval Trend-spotter Project administrator Alerts & reminders ”Name & shame” statistics 11 2nd try

RAIL content What? –Header giving the message in one sentence –Free text description of learning –Take-home message When? –Date Where? –Country & agency name Who? –Project/product –Contact persons Where can I find more? –References to document handling system –Contact persons –Attachments 12

Output, access 13 Who is the system for? RAIL by regulatory, for regulatory All regulatory, across projects and departments Confidentiality by generalising and/or masking Trend spotting tool for Regulatory intelligence

Thanks! 14 Bente Katafai, RAIL administrator Rasmus Engelbrecht, new RAIL champion Thomas Kühler, RAIL sponsor Merete Schmiegelow, for support All RAIL users at Novo Nordisk