In this free webinar, learn about the regulatory submission process, the various types of submissions and how medical writing contributes to each stage. Attendees will learn about common requirements for technical documents and the differences in the application requirements across key regions: US, EU, UK, China and Japan. The featured speakers will discuss how to effectively incorporate standards across documents, understand key messages, integrate pivotal clinical trial documents effectively and more.
TORONTO, Aug. 15, 2024 /PRNewswire-PRWeb/ -- Discover an informative webinar that focuses on best practices for document preparation for a regulatory submission and combines lessons learned over many decades of experience.
Regulatory submissions are essential as they serve as the primary mechanism for regulatory agencies to evaluate the safety and efficacy of new drugs and to approve a drug for marketing and patient use. The preparation of written documentation associated with a submission is fundamental for its eventual success and Medical Writers play a pivotal role in this process.
In this webinar, the expert speakers will delve into the submission process, highlighting the various types of submissions and the role of medical writing at each stage. They will cover the common requirements for technical documents and outline the differences in application requirements across major regions such as the US, EU, UK, China and Japan.
The importance of leadership, precise timing and strategic planning in the submission process will be discussed, emphasizing the need for assembling a key team, setting clear expectations and establishing effective working rules. The webinar will also explore how to consistently incorporate standards across documents, clarify key messages and seamlessly integrate pivotal clinical trial documents.
Moreover, they will examine how individual components of an application contribute to the broader submission strategy, focusing on maintaining quality, the necessity of tracking and documentation, resolving conflicts efficiently and preparing for multiple submissions or follow-up requests.
Register for this webinar today to learn about the specific requirements for regulatory submissions across major global regions, the importance of strategic planning and how to enhance the coherence and quality of technical documentation.
Join experts from ICON, Keith Dawes, Senior Director, Medical Writing; and Tim Weber, PhD, Senior Director, Medical Writing, for the live webinar on Tuesday, September 10, 2024, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Regulatory Submission Writing for NDA Success.
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