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WEBINAR OVERVIEW
Data is the foundation of every successful regulatory submission. In this session, we'll demonstrate how standardizing data at the point of collection leads to efficiency gains in validation, study report authoring, and regulatory submission. You'll learn how the right software solutions for standards governance, dataset validation, GenAI powered writing, and eCTD assembly can work in concert to ensure the integrity and flow of your data from "first patient first visit" to regulatory transfer. Your operations can't afford disjointed workflows. Neither can patients in need. Join the Certara and DIA to explore a practical path from data capture to submission readiness.
FEATURED TOPICS:
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Ensuring submission-ready, validated datasets
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Accelerating CSR development with structured data
- Streamlining eCTD assembly and regulatory delivery
SPEAKER
Somya Agarwal is a Product Manager with 15 years of experience in life sciences software development, specializing in eCTD technology and regulatory submissions. A recognized industry voice, she regularly delivers webinars, client demos, and conference presentations on the latest regulatory and software advancements. Somya has held leadership roles at Certara, Synchrogenix, and HCL Technologies, and has worked closely with global health authorities to shape solutions that advance the regulatory submission process.
Nick Brown is Director, Global Portfolio Leader for Certara.AI; the life sciences-specialized GPT platform. Nick has over 10 years of experience driving AI adoption and customer success across life sciences, federal government and other industries. Prior to Certara, Nick led marketing at Vyasa (now Certara.AI) assisting in the launch and go-to-market strategy for the Layar data platform. He is a graduate of the University of New Hampshire and resides in Andover, MA.
Innovative leader with 20 years of clinical research and healthcare experience, specializing in acquisition, management, and transformation of clinical biospecimen and digital health assessment data. Collaborative creator of tech-enabled solutions for the pharmaceutical industry. Accomplished, analytical director possessing strong interpersonal and communication skills with experience in managing multi-functional teams at both a strategic and tactical level. Key strengths include driving transformational change, strategic planning and execution, spearheading business process improvement initiatives, and building high-performing organizations. Built and introduced countless strategies within R&D to achieve efficiencies and resolve process and application gaps. Experienced in operations oversight and guidance, including resource and financial projections and prioritization.