In this free webinar, learn about the current landscape as well
as the future of regulatory submissions, including the emerging
trends in regulatory writing such as generative artificial
intelligence (AI), automation and lean writing. Attendees will gain
insights into the regulatory expectations with AI and maintaining
standards of compliance. The featured speakers will explore how
these trends will increase the speed and quality of submission
documents.
TORONTO, May 22, 2024
/PRNewswire-PRWeb/ -- This informative webinar is aimed to be
forward-looking, discuss the potential promises of emerging
technological tools in expediting and radically changing submission
preparation, pinpoint potential challenges and brainstorm
resolutions.
There is a possibility of a paradigm shift
in the field, a change that is all radiant and promising, albeit
requiring wise use of these applications.
The current landscape of regulatory submissions is weighed down
by the sheer volume of documentation required, complex guidelines
and repetitive information across documents. It also involves the
painstaking, cumbersome writing styles and processes necessitating
multiple rounds of reviews on the same content across documents,
increasing costs and jeopardizing efficiency and quality, thereby
adding to the already long cycle times of drugs from bench to
bedside.
In the regulatory writing sphere, generative artificial
intelligence (AI), automation, structured authoring, collaborative
authoring and lean writing are slowly making their way into how
work is accomplished. These tools in turn will lead to fast,
efficient and robust filing of marketing authorization
applications. Thus, there is a possibility of a paradigm shift in
the field, a change that is all radiant and promising, albeit
requiring wise use of these applications.
As these concepts and styles are incorporated into how
submissions are approached, the following changes are expected in
the field:
- Radically enhance the speed and quality of the submission
documents
- Free up highly skilled and qualified medical writers from
redundant transactional jobs and engage them more "intelligently" —
to program the automation drivers and generative AI tools
efficiently
- Bring forward approval timelines and thus increase the reach of
drugs to waiting patients faster
- Help shape the regulatory landscape allowing for innovation
with AI
Register for this webinar today to gain insights into the
potential promise of emerging AI tools in expediting and radically
changing how regulatory submissions are prepared.
Join experts from Allucent, Sugato
De, Vice President, Regulatory Strategy, Head of Medical
Technology, Ernesto Vera-Sanchez,
Vice President, Division Head GxP Strategy; and Sushmita Bhattacharya, Sr. Director, Medical
Writing, for the live webinar on Thursday,
June 6, 2024, at 11am EDT
(4pm BST/UK).
For more information, or to register for this event, visit The
Changing Paradigm of Regulatory Submissions: Embracing Automation,
Gen AI, and Innovation for Faster Approvals.
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https://xtalks.com/why-host-a-webinar/
Media Contact
Soumya Shashikumar, Xtalks, +1
(416) 977-6555 x371, skumar@xtalks.com,
https://xtalks.com
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SOURCE Xtalks