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Meluha, The Fern

Feb 28, 2025 8:00 AM - Feb 28, 2025 5:30 PM

Central Avenue, Hiranandani Gardens, Powai, Mumbai 400076, MH, India

DIA Workshop on “Journey of Clinical Trial Data from Regulatory Submissions to Real-world Application”-Crafting Documents That Impact Clinical Practice

Overview

This workshop focuses on bridging the gap between regulatory submissions and real-world clinical practice by exploring the entire data journey. It highlights the key documents and processes that ensure data transitions effectively from clinical trials to impactful clinical decision-making in healthcare. The sessions are designed to offer a mix of theoretical knowledge, interactive activities, and practical applications, culminating in expert insights on leveraging AI for real-world evidence generation. 

Who should attend?

  • Medical Writers 
  • Medical Affairs professionals 
  • Health Economists and Outcomes Researchers: Professionals focusing on real-world data and evidence to support clinical and policy decisions. 
  • Clinical Researchers and Scientists conducting clinical trials or generating real-world evidence for healthcare decision-making 
  • Regulatory Affairs Specialists: Individuals managing regulatory submissions and documentation for clinical trials and approvals. 
  • Healthcare Professionals: Clinicians and practitioners interested in understanding how data transitions into clinical guidelines and recommendations. 
  • AI and Data Science Enthusiasts: Individuals keen on exploring how artificial intelligence can streamline data interpretation and decision-making processes. 
  • Academicians and Students: Those pursuing careers in medical writing, regulatory science, or clinical research. 
  • Pharma and Biotech Professionals: Employees working in roles related to data interpretation, regulatory writing, and clinical application. 

 

Learning objectives

  1. Gain a comprehensive understanding of the data flow from regulatory submissions to clinical application. 

  1. Learn about critical documents that influence clinical and real-world evidence, including guidelines, recommendations, and protocols. 

  1. Develop skills to translate clinical and real-world data into decision-making documents. 

  1. Explore the potential of AI in transforming data into actionable insights for clinical practice. 

  1. Understand best practices through expert discussions and hands-on group activities. 

Program Committee

  • Dr. Deepa Chodankar
    Dr. Deepa Chodankar Heading GENESIS unit
    Sanofi, India
  • Dr. Anant Patil
    Dr. Anant Patil Professor, Dept of Pharmacology
    Dr. DY Patil Medical College, India
  • Pooja Phogat, Ph.D, PhD
    Pooja Phogat, Ph.D, PhD Founder and Co-CEO
    Krystelis Ltd., India
  • Dr. Senthilnathan M
    Dr. Senthilnathan M Country Head – Medical Affairs
    Cipla Ltd, India
  • Hetal Shah, Ph.D
    Hetal Shah, Ph.D Founder - Director
    MeWriT Healthcare Consulting, India
  • Pooja Srivastava Banerjee, MPharm
    Pooja Srivastava Banerjee, MPharm Senior Director & Head, Medical Communications
    Krystelis Ltd, India
  • Dr. Ashok Kumar Swain
    Dr. Ashok Kumar Swain General Manager, India
    DIA, India
  • Yasmin Shenoy
    Yasmin Shenoy Sr Director – Regulatory Affairs
    Sanofi, India

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