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DCMC Session
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Presentation
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Digital Regulatory Submissions: The Future is Near, Are You Ready? | 2023 Digital CMC Summit On-Demand | Presentation

Why now is the time to shift from today's fragmented, burdensome regulatory model to a fit-for-purpose system

Where challenges like data standards, submission processes, and goal alignment need to be collaboratively addressed

How regulators like the FDA are pushing for structured data, digital submissions, and a more collaborative approach

How industry groups, ICH, regulators, and standards bodies are working to enable regulatory transformation

Discover how tomorrow's regulatory environment is taking shape.

With compliance burdens rising to unsustainable levels, calls for a digital regulatory revolution are growing fast. While COVID showed what’s possible with the right alignment and incentives, today’s “new regulatory normal” remains inefficient, heterogenous, and analog – a reality that regulators are now actively pushing to change.

With a new digital regulatory ecosystem on the horizon, leaders from industry, BioPhorum, and the quality/compliance sector came together at the 2023 Digital CMC Summit to share their thoughts on what’s coming next – and how drug developers need to prepare for a transformational shift in regulatory expectations.

Together, they offered their experts views on:

  • Urgent steps that industry must take to prepare for ICH M4Q(2), new IDMP standards, and growing regulatory pressure to structure and digitize submissions.
  • Data framework expectations, quality and compliance targets, and many other digital submission parameters that must be collaboratively defined by industry, regulators, and standards groups.
  • What industry organizations can start doing to prepare for new regulatory requirements: from developing data management strategies to implementing governance foundations, standardizing data assets, and deploying implementation strategies with clear guidelines and objectives.

Register below to watch their full, in-depth presentation.

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Biophorum
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Sue Plant

Sue Plant is the Phorum Director of Regulatory CMC at BioPhorum, a leading network of biopharmaceutical organizations that aims to connect, collaborate, and accelerate innovation. With over 20 years of experience in life sciences, regulatory, and technology, she focuses on improving access to medicines through innovation in the regulatory ecosystem.

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The Henrici Group
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Kir Henrici

Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE — she currently serves on the PDA Regulatory Affairs/Quality Advisory Board.

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QbDVision
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Joschka Buyel

Joschka Buyel is the Director of Product Management at QbDVision. He was previously responsible for the rollout and integration of QbDVision at Bayer and worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.