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

Life Sciences, Pharmaceutical Regulation, Drug Discovery & Development, Commercialization & HEOR, Preclinical,
  • Thursday, June 06, 2024 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

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

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.

Speakers

Sugato De, MS, Allucent

Sugato De, MS, Vice President, Regulatory Strategy, Head of Medical Technology, Allucent

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.

Message Presenter
Ernesto Vera-Sanchez, Allucent

Ernesto Vera-Sanchez, MD, PhD, MPH, Vice President, Division Head GxP Strategy, Allucent

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.

Message Presenter
Sushmita Bhattacharya, Allucent

Sushmita Bhattacharya, PhD (IIT), MBA, Sr. Director, Medical Writing, Allucent

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.

Message Presenter

Who Should Attend?

This webinar will appeal to VPs, Directors, Managers and Heads involved in:

  • Research and development
  • Regulatory affairs
  • Medical writing
  • Medical affairs
  • Scientific affairs/consulting
  • Clinical pharmacology
  • Pharmacometrics
  • Clinical development
  • Project management
  • Clinical Operations
  • Clinical Research
  • Biostatistics and Data Management
  • Preclinical/Nonclinical Research

This webinar will also appeal to:

  • Chief Medical Officers (CMOs) and CEOs of small and medium-sized biotech and pharmaceutical companies
  • Academics from drug discovery centers or groups
  • Venture capital and other life science investment groups

What You Will Learn

Attendees 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

Xtalks Partner

Allucent 

Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.

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