The Changing Paradigm of Regulatory Submissions: Embracing Automation, Gen AI, and Innovation for Faster Approvals

Watch this informative webinar that is aimed to be forward-looking, discussing the potential promises of emerging technological tools in expediting and radically changing submission preparation, pinpointing potential challenges, and brainstorming 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.

What you will learn about:

  • Current landscape of regulatory submissions
  • Emerging trends in regulatory writing such as generative AI, automation and lean writing
  • The regulatory expectations with AI and maintaining standards of compliance
  • How these trends will increase the speed and quality of submission documents
  • The future of regulatory submission preparation

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About the Presenters

Sugato De

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

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

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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