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Upcoming Webinar: Clinical Trial Application Success

In today's fast-paced pharmaceutical landscape, the success of clinical trials hinges on effective planning and execution. A significant opportunity arises on September 3, 2025, as Xtalks hosts a free webinar titled Clinical Trial Application Success: CMC and Regulatory Insights from the US to Europe. This session aims to provide invaluable insights for stakeholders involved in the submission of Investigational New Drug (IND) applications in the United States and Clinical Trial Applications (CTA) in Europe.

Key Focus Areas of the Webinar

During this informative session, participants will delve into several essential topics:

• - Optimizing IND and CTA Submissions: Understanding the technical and regulatory dimensions of IND and CTA submissions is crucial. The webinar will shed light on best practices and successful strategies to align chemistry, manufacturing, and controls (CMC) with regulatory expectations.

• - CMC Requirements: The speakers will cover the pivotal CMC requirements for early-phase drug development. Attendees will learn about common challenges faced during this phase and practical solutions to navigate them effectively.

• - Navigating Regulatory Landscapes: A discussion on regulatory requirements from agencies such as the FDA and the European Medicines Agency (EMA) will be central to the presentation. Key insights into filing processes, importation regulations for investigational drugs in the EU, and tips for transitioning from US to EU trials will be discussed.

Expert Guidance: Real-World Insights

The webinar features seasoned professionals in the field; attendees will hear from:

• - William Lian, Director of Filing and Regulatory Affairs Office at BioDuro
• - Arna Hrund Arnardóttir, PhD, Senior Consultant at DADA Consultancy

Both experts bring a wealth of knowledge from their experiences in supporting global submissions and overcoming regulatory hurdles during IND and CTA preparation.

Registration and Participation

This unique opportunity to enhance your knowledge in clinical trial application processes is open to all interested participants. To register, simply visit the Xtalks registration page and secure your spot today. This engaging session will not only provide insights into avoiding regulatory gaps but also equip you with the techniques to enhance submission efficiency and success rates.

Why Attend?

The growing complexity of global clinical trials necessitates continuous education and awareness of diverse regulatory requirements. By participating in this webinar, you will gain:

• - Valuable insights that can be applied in real-world scenarios
• - Networking opportunities with industry leaders and peers
• - Access to resources designed to support the advancement of your projects

In an era where timely drug development can make a difference in healthcare outcomes, the knowledge shared in this webinar can be instrumental for professionals working in the pharmaceutical, biotechnology, and medical device industries.

Join us to discover how to enhance the chances of success for your clinical trials and streamline the journey from submission to approval. For more information, visit Xtalks for updates and further details on the event.