building a framework for analytical chemistry data across the pharmaceutical industry
TRANSCRIPT
Presented by Gerhard Noelken (Pfizer)
On behalf of Allotrope Foundation
web: www.allotrope.org mail: [email protected]
©2014 Allotrope Foundation
©2014 Allotrope Foundation
We pay regulatory professionals to do what?!?!
• we manually compile and write static reports – IND, NDA, MAA, NDS, JNDA, etc.
– Generation of regulatory responses
– Post-approval changes
– Annual reports
– Supporting drug information requests
– Complying with new regs on established products (retroactively accessing “ancient” data)
– Certificates of analysis
– Stability reports
– Specifications
– et cetera
At work… At home… • computers give us
button-click, interactive, drill-down reports
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©2014 Allotrope Foundation
Benefits of the Allotrope Framework: Regulatory
Streamlines analytical CMC data collection
and compilation
Facilitates easy access to legacy information
Consistent document preparation for
electronic submissions
Helps ensure accurate, complete,
& consistent responses to
regulatory inquiries
Better management of post approval changes
– Solves the ‘Where Used’ problem.
Elimination of data transcription errors
and missing data
Consistent data and document format
conversions
Easy Integration with commercial and exist
in-house software
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