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.
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.
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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To learn more about Xtalks visit https://xtalks.com
For information about hosting a webinar visit
https://xtalks.com/why-host-a-webinar/
Media Contact
Vera Kovacevic, Xtalks, +1 (416)
977-6555 x371, vkovacevic@xtalks.com, https://xtalks.com/
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