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Regulatory Submission Writing for NDA Success

 
  June 11, 2024  
     
 
Xtalks, Online
2024-09-10


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.

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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.

Keywords: Drug Development, Clinical Research, Regulatory Submission Process, Regulatory, Regulatory Affairs, Medical Writing, Medical Communications, Regulatory Submission, Scientific Communications
 
 
Organized by: Xtalks
Invited Speakers: Keith Dawes, Senior Director, Medical Writing, ICON
Tim Weber, PhD, Senior Director, Medical Writing, ICON
 
Deadline for Abstracts: 2024-09-10
 
Registration: Free Registration
E-mail: tristan@xtalks.com
 
 
   
 
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