AMWA Webinar:GenAI in Action: Demo and Real-World Case Studies Transforming Medical Writing in Global Pharma

March 26,2025
Online (Live Webinar)

Event: AMWA Webinar 2025

Date: Wednesday, March 26,

Time: 1:00 PM - 2:00 PM EDT

Location: Online (Live Webinar)

The American Medical Writers Association (AMWA) is the resource for professional medical communicators, promoting excellence in medical communication and providing educational resources in support of that goal. Founded in 1940, AMWA is the leading professional organization for writers, editors, and other communicators of medical information.


Webinar Information:

Topic:GenAI in Action: Demo and Real-World Case Studies Transforming Medical Writing in Global Pharma
This session will present an off-the-shelf GenAI-powered Medical and Regulatory Authoring platform, proven in global pharmaceutical deployments. This webinar will showcase real-world case studies via the AuroraPrime platform—a trusted Word add-in already implemented by 10 global pharmaceutical companies and several leading CROs. The platform revolutionizes regulatory and medical writing by:
  • Significantly reducing first-draft time for CSRs and protocols

  • Delivering 30–50% overall time savings for CSRs, as validated by two of the world’s top ten pharma companies

Join us for a live demonstration of AuroraPrime’s most impactful GenAI features, designed to enhance compliance, quality, and consistency. Hear how forward-thinking teams are accelerating timelines and adopting best practices in clinical document creation. Attendees will gain actionable strategies, deeper insight into real-world GenAI applications, and proven examples of measurable benefits.

  
Register:https://www.amwa.org/events/EventDetails.aspx?id=1937030&group=


Learning Objectives:

Key points to explain and demo include:
  • Integrated Authoring Solution
    • Demonstrate a Word plugin designed to seamlessly integrate with existing workflows and upstream/downstream systems (e.g., Veeva RIM) to automate document assembly.

  • Cross-Document Content Reuse & Standardization
    • Demonstrate a GenAI framework for reusing and standardizing content across multiple document types, enabling enterprise-wide, scalable authoring.

  • GenAI-Driven Quality Control
    • Explanation of an automated quality control process harnessing GenAI to ensure accuracy, consistency, and regulatory compliance.

  • Change Management Strategy
    • Practical insights and lessons learned from enterprise deployments, including approaches and best practices for effective GenAI adoption, along with measurable outcomes and cost-effective strategies.

  
Target Audience:
  • Medical Writers and Regulatory Executives seeking automated, GenAI-driven tools

  • Regulatory and Medical Writing Professionals aiming to enhance efficiency

  • Digital Innovation, R&D, IT and Clinical Development Leaders integrating GenAI into writing processes

  

About the Presenters:

Sharon Chen, Founder and CEO, AlphaLife Sciences.
Sharon Chen is the visionary Founder and CEO of AlphaLife Sciences, where she spearheads generative GenAI-powered solutions that are transforming drug development. With over 30 years of experience in software development, Sharon previously led as Asia Pacific General Manager at Verily Life Sciences (an Alphabet company) and served as Engineering Director at Google. At Google, she earned the Founder's Award and Outstanding Leadership Award for her exceptional contributions. Sharon's innovative leadership and deep expertise make her a leading figure in the intersection of computer science and life sciences, driving significant advancements in the industry.
  
Karen J. Devcich, MS, MBA, Vice President, Medical Writing, Quality & Editing and Clinical Trial Transparency, ICON plc
Karen J. Devcich is an accomplished clinical development professional with over 30 years of industry experience across various roles in leading pharmaceutical organizations. She provides strategic and operational oversight for multiple programs spanning all phases of development. With extensive experience in investigational new drugs (INDs), clinical trial applications (CTAs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and global submissions, Karen is a recognized expert in Clinical Trial Transparency across multiple therapeutic areas. She has played a pivotal role in developing policies and procedures for implementing Clinical Trial Registries and Disclosures, including Clinical Trial Data Sharing. With over 9 years in Clinical Research Organization (CRO) experience, Karen has worked within both Full Service and Functional Service Provider models. She is deeply motivated by the potential of innovative medicines to improve patients' lives.
  
Cieayrra Boozer, Product Solution Specialist, AlphaLife Sciences
With over a decade of experience in the life sciences, Cieayrra offers strategic expertise in operations and product consulting. Leveraging deep industry knowledge, Cieayrra helps deliver strategic approaches and solutions to address the needs of the industry and the drug development process.
  
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