Loading…
arrow_back View All Dates
Thursday, June 19
 

9:00am EDT

#403: How AI is Transforming the Area of Data Standards and Access to Source Data
Thursday June 19, 2025 9:00am - 10:00am EDT
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-670-L04-P; CME 1.00; RN 1.00

The use of generative AI (genAI) is already shown to be useful in content generation. The use of genAI to accelerate development and maintainance of data standards and data transformation is rapidly evolving as it will be shown in this session.

Learning Objectives

Describe the current landscape of AI applications for developing, maintaining, and utilizing data standards to accelerate access to source data in electronic health records (EHRs) and registries; Evaluate how AI is currently shaping data standardization and transformation and anticipate its future impact on the landscape.

Chair

Jesper Kjær, MS

Speaker

Industry Feedback to AI in Data Standards
Robert DiCicco, PharmD

OHDSI OMOP AI and open science
Patrick Ryan

CDISC and AI
Chris Decker, MS

HL7 and the AI Train
Charles Jaffe, MD, PhD, FACMI, FACP


Speakers
avatar for Chris Decker

Chris Decker

President and CEO, United States
Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development... Read More →
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. where for the last 3 years he has headed up a suite of programs that include Pragmatic Trials along with several digital and data driven transformational projects. He was the Chief Health Officer... Read More →
CJ

Charles Jaffe

Chief Executive Officer, HL7, United States
Dr. Jaffe is the CEO of Health Level 7 International (HL7). He completed his medical training at Johns Hopkins and Duke Universities and post-doctoral training at the National Institutes of Health and the Lombardi Cancer Center. At NIH, he worked in the Laboratory of Clinical Investigation... Read More →
avatar for Jesper Kjaer

Jesper Kjaer

Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk, Denmark
Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been... Read More →
PR

Patrick Ryan

Vice President Observational Health Data Analytics, Janssen Pharmaceuticals, Inc., United States
Patrick Ryan, PhD is Senior Director of Epidemiology and the Head of Epidemiology Analytics at Janssen Research and Development. He is currently a collaborator in Observational Health Data Sciences and Informatics (OHDSI, htttp://ohdsi.org). He served as a principal investigator of... Read More →
Thursday June 19, 2025 9:00am - 10:00am EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

9:00am EDT

#404: Embedding and Leveraging AI for Quality and Compliance in Pharma
Thursday June 19, 2025 9:00am - 10:00am EDT
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-671-L04-P; CME 1.00; RN 1.00

This session explores the transformative potential of AI in pharma quality and compliance, sharing use cases, strategies, and regulatory insights. Attendees will learn how AI can transform quality and compliance in pharmaceutical companies.

Learning Objectives

Describe AI use cases in pharmaceutical quality management and compliance processes; Recognize the role, benefits, and risks of using AI in quality management; Discuss strategies for integrating AI technologies into existing pharmaceutical quality and compliance frameworks.

Chair

Hangyu (cedric) Liu, MS

Speaker

AI and the Quality Professional
Michael Pelosi, MA, MBA, MSc

AI in Pharma Quality and Compliance
Roshan D'Souza

Explainable Natural Language Processing: Why you see What you see
Meera Nagaria, MS


Speakers
avatar for Roshan D'Souza

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche Products Limited, United Kingdom
Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →
avatar for Hangyu (cedric) Liu

Hangyu (cedric) Liu

Associate Director, AI/ML, Biogen, United States
Hangyu Liu is currently an Associate Director of Artificial Intelligence Innovation at Biogen. He leads an advanced analytics group with a focus on R&D portfolio and quality analytics. He obtained a Master's degree in Data Science from Brown University. His research interests include... Read More →
avatar for Meera Nagaria

Meera Nagaria

Senior Data Scientist, Johnson & Johnson, United States
avatar for Michael Pelosi

Michael Pelosi

Director, Quality Analytics, Astellas, United States
Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.
Thursday June 19, 2025 9:00am - 10:00am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session
 
  • Filter By Date
    Jun 9 - 19, 2025
    June 2025
    SunMonTueWedThuFriSat
    1234567
    891011121314
    15161718192021
    22232425262728
    2930 
  • Filter By Venue
  • Filter By Type
  • Level
  • Keyword
  • Timezone

Share Modal

Share this link via

Or copy link

Filter sessions
Apply filters to sessions.
Filtered by Date -