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Bethesda North Marriott Hotel and Conference Center

2027年2月08日 (月) 午前 10:00 - 2027年2月10日 (水) 午後 12:45

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Data Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document and data management (RSIDM)!

Early Bird Ends In

DAYS

HOURS

MINUTES

SECONDS

概要

February 8-10: Forum

As regulatory operations continue to evolve, organizations are increasingly being challenged to move beyond document-centric processes toward more connected and data-enabled ways of working. Success today depends not only on the ability to prepare and deliver high-quality submissions, but also on how effectively organizations manage information, structure data, optimize processes, and align the people, systems, and technologies that support regulatory work.

At DIA’s Regulatory Submissions, Information, and Data Management (RSIDM) Forum, industry and regulatory stakeholders come together to examine the standards, requirements, technologies, and approaches shaping the current and future state of regulatory operations. While the RSIDM acronym remains unchanged and continues to reflect the Forum’s established identity, the inclusion of “Data” in the meeting name more accurately reflects the growing importance of data in regulatory submissions, information management, process improvement, and technology adoption.

Through four focused tracks, the Forum provides practical insights on how to build and sustain strong RSIDM foundations, optimize processes and procedures, adopt innovative technologies, and strengthen strategic leadership and organizational readiness. The Forum also offers opportunities for education, networking, and knowledge sharing for both business- and technology-focused professionals at all levels.

While we develop our 2027 agenda, please take a moment to review the 2026 final agenda

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Want to learn more about Regulatory Submissions, Information, and Data Management Forum? You've come to the right site!

Highlights & Features

参加対象

  • Forum Designed For

    • Clinical Data/Data Managers
    • Clinical Operations and Processes
    • Contract Research and Service Support Providers
    • Document and Records Management/Specialists
    • Emerging Pharmaceutical/Biotech/Device Professionals
    • Essential Document Process and Business System Owners
    • Informatics/Bioinformatics Professionals
    • Information Technology and Support Personnel
    • Medical, Technical, and Regulatory Writers
    • Outsourcing/Clinical Outsourcing
    • Quality Assurance/Quality Control and Compliance Professionals
    • Quality Management
    • Regulatory Affairs and Operations
    • Regulatory Informatics
    • Regulatory Information Management
    • Regulatory Standards Implementation Specialists and Associates
    • Strategic Planning and Operations
    • Submissions and Global Submissions Management/Project Management
    • TMF and eTMF Management
    • Vendor Relationship Managers

プログラム委員会

  • Nimesh  Patel
    Nimesh Patel Senior Director of Global Regulatory Systems
    Eisai Co., Ltd., United States
  • Noelia  Plaza
    Noelia Plaza Director of Process Excellence & Analytics
    Daiichi Sankyo, United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Advisor, Office of Digital Transformation
    FDA, United States
  • Karin  Schneider, MLIS, MS
    Karin Schneider, MLIS, MS Associate Director
    Johnson & Johnson, United States
  • Alisa  Amirova
    Alisa Amirova Manager, Regulatory Information Management & Technology (RIMT)
    Biomarin Pharmaceutical, United States
  • Vladimir  Penkrat, MBA
    Vladimir Penkrat, MBA
    Indegene, United States
  • Venkatraman  Balasubramanian, MBA
    Venkatraman Balasubramanian, MBA Healthcare and Life Sciences Strategic Advisor
    VB Insights, LLC, United States
  • Kunal  Lal, MBA
    Kunal Lal, MBA Consultant - Strategy & Change
    Red Nucleus, United Kingdom
  • Shenqi (Handsome)  Ji
    Shenqi (Handsome) Ji Publishing Regional Director, Asia, Global Regulatory & International Operations
    Pfizer, China
  • Seyoum  Senay, MS
    Seyoum Senay, MS Supervisory Operations Research Analyst, CDER/OBI
    FDA, United States
  • Lorelle  Leonienco, PMP
    Lorelle Leonienco, PMP Product Manager
    LORENZ Life Sciences Group, United States
  • Jennifer  Dames
    Jennifer Dames Director, RA Submission Management
    AbbVie, United States
  • Katherine  Novak, MS
    Katherine Novak, MS Director
    Epista Life Science, United States
  • Rachel  Bombara
    Rachel Bombara Sr. Regulatory Services Manager
    Certara, United States
  • Aliza  Nathoo
    Aliza Nathoo Senior Director, Content Strategy
    Hoffmann-La Roche Limited, Canada
  • Rita  Algorri, PHD, MS
    Rita Algorri, PHD, MS Associate Director, Global Regulatory Affairs (CMC)
    Amgen, United States
  • Ashley  Jones-Mitchell, MPH
    Ashley Jones-Mitchell, MPH Head of Global Regulatory Policy
    Accumulus Synergy, United States
  • Lindsay  Fitzgerald
    Lindsay Fitzgerald Delivery Manager
    Astrix, United States
  • Theresa  Pinnell, MLS
    Theresa Pinnell, MLS Director of Regulatory Solutions
    Kivo, United States
  • Kevin  Tompkins, MBA
    Kevin Tompkins, MBA Executive Director, Regulatory Information & Submission Management
    Bristol Myers Squibb, United States
  • John  Popp, PHD
    John Popp, PHD Senior Manager - Regulatory Information Management
    Celegence, Netherlands
  • Jasmine  Gupta
    Jasmine Gupta Global Regulatory Affairs Lead
    Synthekine, United States

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