2023 DIGITAL CMC SUMMIT / ON-DEMAND SESSION
Digital Regulatory Submissions: The Future is Near. Are You Ready?
Three experts share what’s driving industry and regulators toward global harmonization and digitalization.
Session highlights & insights
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
Session Speakers
Meet the group of transformation experts sharing their insights and expertise in this on-demand session.
SUMMARY
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.
Stream these exclusive insights from the 2023 Digital CMC Summit.
Sign up to watch nine full sessions captured live at the 2023 Digital CMC Summit — including in-depth presentations, Q&A, and moderated deep-dives into our industry’s digital future.
