Clinical Trial Application Success: CMC and Regulatory Insights from the US to Europe

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:

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

Watch On-Demand

Speakers:

William Lian

Director of Filing and Regulatory Affairs Office

BioDuro

Arna Hrund Arnardóttir Ph.D.

Senior Consultant

DADA Consultancy