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RSIDM 2021: Qdossier presenting on IDMP & Data Management

8 February 2021 @ 10:00 - 10 February 2021 @ 16:15

DIA’s Regulatory Submissions, Information, and Document Management Forum (RSIDM 2021) brings together industry and regulatory stakeholders working across the scope of regulatory information to examine current data standards and requirements and effective regulatory information management approaches to align related systems. The Forum presents four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Electronic Document Management, and Electronic Regulatory Submissions. Cross-track sessions provide the opportunity to discuss key connection points across major components of regulatory information, and plenary sessions featuring regulatory intelligence updates by FDA and other regulatory authorities are offered each day.

Hans van Bruggen will be present on: ‘Blue Sky IDMP-Compliant Process as Reference for Gap Analyses’.

In this sessions he will compare the blue sky process with currently, often fragmented ways of managing data related to IDMP. He will go deeper into building reliability of data by design and speak about establishing a comprehensive lean data reuse, supporting manufacturing, supply chain and regulatory affairs.

Michiel Stam will present on: ‘Building a culture around data for successful registration tracking; the transformation of a data management office’

In this session he will share experiences and ideas for performance improvement of the data management team. He will speak about the challenges related to the (re-)organisation of people, processes and systems in data management and identify and share requirements for successful product- and registration tracking.

We hope to meet you virtually at RSIDM 2021!