Unlock the Future of Regulatory Submissions: Join Our Lean Authoring Webinar

Regulatory submissions have always been a complex maze, requiring both precision and speed to meet strict Health Authority standards. But what if there was a way to significantly streamline your submission processes, saving valuable time and effort while maintaining compliance?

Join us on December 3rd at 10 AM ET for our highly anticipated webinar, “Efficiency in Regulatory Submissions: Apply the Power of Lean Authoring.” This session will introduce you to Lean Authoring, a revolutionary approach that’s transforming the way Regulatory Affairs teams manage their submissions.

Lean Authoring is a new, efficient methodology that redefines how data is structured from the very beginning of the submission process. By carefully organizing data, you’ll reduce the number of documents needed and ensure they are ready for rapid regulatory impact analyses and document comparisons.

The result? Streamlined submissions that are not only easier to manage but also provide faster regulatory decisions—putting your products on the market sooner.

During this webinar, our experts will explore:

• The Core Principles of Lean Authoring: Learn how this approach accelerates internal workflows and ensures compliance with evolving Health Authority requirements.
• Real-World Comparisons: See how Lean Authoring stacks up against traditional methods, including how data separation enhances document reuse across multiple submissions.
• Best Practices: Discover how this methodology can optimize your document creation process, saving both time and resources.

Whether you’re looking to fast-track your global market access or optimize your data governance, this webinar will provide actionable insights you won’t find anywhere else.

This webinar is tailored for senior Regulatory Affairs professionals, including Directors, VPs, and team leaders in the pharmaceutical industry, who are responsible for submission processes and compliance management. Learn how Lean Authoring can transform your submission workflows and keep you ahead of regulatory changes, including IDMP standards and data exchange requirements.

• Hans van Bruggen, Chief Scientific Officer, Celegence: With over 40 years of experience in the pharmaceutical industry, Hans has a deep understanding of the data and documents required for regulatory submissions. His expertise in dossier preparation and benefit/risk evaluation will provide attendees with invaluable insights.
• Marloes van der Geer, Head of Regulatory Affairs, Celegence: Marloes brings her passion for regulatory simplification and harmonization to the table, having worked across global regulatory landscapes. Her hands-on experience with regulatory procedures will help attendees navigate complex submission requirements with confidence.

If you’re ready to revolutionize your regulatory submissions and enhance efficiency through Lean Authoring, don’t miss this exclusive opportunity. Register Now to secure your place!

All registrants will receive a copy of the webinar recording following the live event. Register now and don’t miss out!

Stay ahead of the curve and ensure that your submission processes are as streamlined as they can be.