Moving from Regulatory Document Submission to Data Collaboration


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Event Type

New Idea ‘Regulatoria’ Round Table Discussion

Problem Statement

CMC Regulatory Specialists spend a lot of time copy-pasting and reformatting information from
source documents into regulatory documents. Such Word/PDF processes result in unFAIR data.
Besides they are commonly the root causes of slowness, waste/inefficiency, and compliance risk in
regulatory dossier preparation, submission, and assessment. Given FDA PQ/CMC and ICMRA PQ KMS
projects, Applicants should anticipate the day Authorities enforce pharmaceutical quality CMC
information collaboration based on FAIR data in addition to their usual regulatory document

Call for Interest

Pistoia Alliance calls on its members to express their interest in a new project called ‘Regulatoria’. Its
scope starts with drug stability data.

The project first goal is to develop a model of drug stability. Its
members can use that model to map and structure their drug stability data from their various source
systems. The second goal is to study options for data collaboration and exchange with Health
Authorities. The project may eventually scale up to other pharmaceutical quality CMC information.


Birthe Nielsen and Véronique François, Pistoia Alliance


Jean-Pierre Doan, Merck KGaA, Global Regulatory Affairs CMC & Medical Devices Digitalization

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