Yatesh Midha, Saama

Building the Agentic Data Manager: A Hands-On Build Lab

8:00 AM - 12:30 PM

Clinical Data Management is evolving from static data curation to a dynamic landscape where Agentic AI can anticipate needs, execute complex workflows, and collaborate with humans. This workshop introduces clinical data professionals to the practical foundations of agentic AI and explores how these emerging capabilities can be applied within regulated clinical research environments.

Sujata Aiyangar, Accenture & Jayasmita Dutta, Zensar

Your Project Plan Is Already Your Brand. Nobody Told You.

8:00 AM - 12:30 PM

Most clinical data professionals believe their work should speak for itself. But what happens when brilliant work goes unnoticed?
This workshop explores an uncomfortable truth about visibility, influence, and the role your everyday project work already plays in shaping your reputation. You may discover that the story defining your career is already being written - whether you're telling it intentionally or not.

Joanna Florek-Marwitz, UCB & Sas Maheswaran, CluePoints

RBQM in Clinical Data Management

1:30 PM - 6:00 PM

Risk-Based Quality Management is no longer optional.
With ICH GCP E6(R3) reinforcing a risk-proportionate, quality-by-design approach, this hands-on workshop explores the full RBQM lifecycle - from identifying Critical to Quality Factors and assessing study-specific risks to setting meaningful KRIs and QTLs. Through interactive case studies, discover how risk-based approaches and Centralized Statistical Monitoring help teams focus on what matters most and uncover signals traditional monitoring can miss.

Dawn Kaminski, eClinical Solutions & Dan Crawford, Veeva Systems

Mastering FDA Data Submission Standards alongside PMDA, EMA, and MHRA Frameworks

1:30 PM - 6:00 PM

Navigating the complex maze of global clinical data requirements is a critical hurdle for data managers, clinical programmers, medical monitors, and senior leadership. Led by industry veterans Dawn Kaminski and Dan Crawford, who each bring over 25 years of industry experience, "Mastering FDA Data Submission Standards alongside PMDA, EMA, and MHRA Frameworks " delivers an intensive, end-to-end roadmap for building submission-ready data packages. Attendees will learn foundational CDISC architectures (CDASH, SDTM, ADaM) and essential technical metadata (Define.xml, cSDRG, aCRFs) while bridging the gap to international expectations. This workshop will examine how core US submission data requirements align with global regulatory standards, exploring the validation requirements of Japan’s PMDA, the EMA's upcoming raw data pathways, and the UK MHRA’s requirements for the International Recognition Procedure (IRP). Complete with look-ahead previews of emerging AI review engines (like FDA's ELSA platform) and future standards like Dataset-JSON, this interactive experience will equip you with a solid, globally aligned foundation to successfully submit data to the FDA and beyond.