Clinical Trial Application Success: CMC and Regulatory Insights from the US to Europe, Upcoming Webinar Hosted by Xtalks

In this free webinar, gain insights on optimizing Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions through aligned chemistry, manufacturing and controls (CMC) and regulatory strategies. Attendees will learn about key CMC requirements for early-phase development and strategies to leverage accelerated CMC programs. The featured speakers will discuss EMA and FDA clinical trial authorization requirements. The speakers will also share strategies to minimize regulatory gaps when transitioning from US to EU trials. Attendees will learn about the development support provided by the FDA and EMA, requirements for the importation of the investigational drug into the EU and more.

TORONTO, Aug. 15, 2025 /PRNewswire/ -- The Investigational New Drug (IND) application in the US and Clinical Trial Application (CTA) in Europe are key milestones in advancing innovative therapies to clinical development. This webinar will discuss the technical and regulatory aspects of IND and CTA submissions in the US and Europe.

The speakers will explore CMC requirements, highlighting key technical challenges and practical solutions encountered during the early-phase development of both the drug substance and drug product. The speakers will also address the regulatory landscape, discussing EMA and FDA filing requirements, importation requirements for the EU and strategies for transitioning from US-based to EU-based trials.

Whether it's a robust CMC strategy or a well-planned regulatory approach, both play a crucial role in enhancing the success rate and efficiency of IND submissions. Join this webinar to learn how expert perspectives from CMC and regulatory specialists can help minimize regulatory gaps, optimize timelines and streamline early-phase development.

Join the featured speakers to explore:

• Real-world insights on overcoming CMC hurdles during IND and CTA preparation
• Approaches to aligning technical documentation with evolving regulatory expectations
• Lessons learned from supporting global submissions across the US and EU

Register to gain practical insights on optimizing IND and CTA submissions through aligned CMC and regulatory strategies.

Join William Lian, Director of Filing and Regulatory Affairs Office, BioDuro; and Arna Hrund Arnardóttir, PhD, Senior Consultant, DADA Consultancy, for the live webinar on Wednesday, September 3, 2025, at 10am EDT (4pm CEST/EU-Central).

For more information, or to register for this event, visit Clinical Trial Application Success: CMC and Regulatory Insights from the US to Europe.

ABOUT XTALKS

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Vera Kovacevic
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