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.
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
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About the Presenters
Sugato De, MS – Vice President, Regulatory Strategy, Head of Medical Technology
As a previous Senior Policy Advisor at the FDA, as well as a seasoned leader within the CRO industry, Sugato De has cultivated expertise in a plethora of regulatory pathways, including dossiers for combination products, expedited pathways, protocol development for medical devices and more. During his 11-year tenure with the Center for Devices and Radiological Health (CDRH) at the US FDA, Sugato developed specialized expertise in drug-device combination products, digital health technologies and critical care medicine.
Ernesto Vera-Sanchez, MD, PhD, MPH – Vice President, Division Head GxP Strategy
Dr. Ernesto Vera-Sanchez has nearly 20 years of experience as a regulator and an EMA & AEMPS GxP Inspector. His comprehensive knowledge of clinical trial regulations and guidance from EMA/FDA/MHRA/PMDA, as well as his extensive experience in inspection strategy and related procedures, lend to his wide-ranging expertise. Ernesto has led over 400 regulatory inspections at clinical investigator sites, CROs, sponsors and vendors.
Sushmita Bhattacharya, PhD (IIT), MBA – Senior Director, Medical Writing
Through being a knowledgeable medical writing leader with over 14 years of experience within several top pharma and CRO, Sushmita has garnered intensive experience across regulatory documents, publications, transparency, imaging and quality. She has expertise on leading submissions aimed for the US FDA and EMA. She has led cross-functional initiatives employing lean and Six sigma and championed ways of bringing efficiencies into regulatory medical writing and submissions through adoption of latest techniques in writing and integrating technology and automation with the skill of medical writing.
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