WEBINAR ON DEMAND
EU IDMP Implementation: DADI and the agile way forward
Beginning of this year, European Medicines Agency (EMA) has finally broken cover and publicly confirmed the closed circle information and rumors spreading in the previous months: the DADI (Digital Application Dataset Integration) project will now serve as the ‘agile Plan’ to move forward with the implementation of regulatory data submissions as the way to achieve the planned PMS go-live.
About the webinar
In this webinar, we’ll discuss and learn about:
- the DADI project and how it relates to the EU IDMP Implementation
- our key takeaways – what DADI will support and won’t deliver
- the impact of DADI on the industry
- how to respond to the change and adjust plans for a data-driven regulatory future if needed
About the speakers
Agnes Cwienczek
ALSS Head of Product Management and Consulting
Agnes has been in the position of ALSS Head of Product Management and Consulting since May 2017. Her main responsibilities are the contribution to the development and enhancement of the Amplexor Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, and Submission Management.
Before joining Amplexor, Agnes worked at Merck KGaA in Global Regulatory and Quality Assurance, where she was acting System and Process Owner for all regulatory owned systems, providing global leadership for the management of submission documents, regulatory data and archiving within the Merck Biopharma organization.
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