Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

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

Overview

February 6: Short Course

February 8: Short Course

February 8 and 12: Primer

February 12-14: Forum

The last few years have shed light on the importance of operational efficiency of the management of regulatory information to ensure quality regulatory submission to health authorities. We have seen how the ability to perform at this level has allowed drug companies to bring therapeutics and vaccines to patients faster. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, we will hear from industry and regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology. New for 2024, our Forum brings a refreshed set of tracks and focus areas, equipping our attendees with invaluable insights on how to build and sustain successful RSIDM foundations, optimize their current processes and procedures, adopt innovative technologies, and achieve regulatory excellence. This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees at all levels.

Featuring:

27 educational sessions, 90+ diverse speakers from regulatory, industry and academia, 8 networking opportunities, 30+ exhibitors & sponors, 4 hosted case study spotlights, 2 pre-forum virtual Short Courses, 1 pre-forum hybrid Primer, and more!

Participant Testimonials

The forum was incredibly valuable in terms of meeting colleagues from around the world —industry and regulators — and collaborating on solutions to improve submission efficiency andmake data more readily usable. – Virginia Hussong, Chief Data Standards Program, CBER, FDA

Fantastic forum! I am 17 years in the pharmaceutical industry, but new to the regulatory sector, and it was great to align my prior manufacturing knowledge to the regulatory area. Great event! All the right people, all in the right place! – Matthew Tyler, Director of Business Development, Qdossier, a Celegence Company

The breadth of subject matter expertise, and diverse perspectives make RSIDM a must attend event for anyone involved in Regulatory activities. – Gary Colantonio, MS, MBA, Associate Director, Regulatory Affairs, Merck & Co., Inc.

Keynote Address!

February 12 | 1:25 - 2:00 PM

Keynote Address

Session 1: Keynote Address : Fostering Trustworthy and Responsible AI

The Keynote has Been Released! Reggie Townsend, MBA, Vice President, Data Ethics, SAS

Featured

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

Continuing Education

Exhibits

View our Exhibit Partners and explore our latest offerings

Highlights & Features

Stay in the know with what's going on at the event

Welcome Video

Who should attend?

  • Meeting Designed For

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

Learning objectives

  • At the completion of this conference, the participant should be able to:

    • Develop insights into effective strategies for establishing and sustaining robust regulatory submission, information, and document management foundations
    • Explore techniques to enhance organizational processes and procedures, fostering a culture of innovation and forward-thinking
    • Gain thought-provoking insights on effectively adopting innovative technologies, such as artificial intelligence and automation, into your organization
    • Develop a comprehensive understanding of the elements required for achieving regulatory excellence in the life sciences industry
    • Discuss current global regulatory authority updates and key initiatives as it relates to data standards, analytics, electronic submissions, and IT programs

Short Course or Primer

To keep you at the forefront.

Feb 06, 2024

Short Course:

Driving IDMP Readiness and Compliance

Feb 08, 2024

Short Course:

Mapping Common Regulatory Data Standards to FHIR

Program Committee

  • Jo  English
    Jo English
    IRISS Forum, United Kingdom
  • Sandra  Krogulski, MA
    Sandra Krogulski, MA Director, GRSO Innovation and Business Operations Lead
    Bristol-Myers Squibb Company, United States
  • Ethan  Chen, MBA, MS, PMP
    Ethan Chen, MBA, MS, PMP Director, Division of Data Management
    FDA CDER, United States
  • Rob  Labriola, MS
    Rob Labriola, MS Exec. Director, Regulatory Operations
    Garuda Therapeutics, United States
  • Jamie  O'Keefe
    Jamie O'Keefe Head, Clinical & Regulatory Consulting
    Astrix, United States
  • Alison  Buno, MBA
    Alison Buno, MBA Senior Director, Regulatory Submissions
    AbbVie, Inc., United States
  • Jillian E. Carinci, MS
    Jillian E. Carinci, MS Senior Director, Head of Submission Sciences
    Biogen, United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States

Digital Learning Catalog

DIA Learning: eLearning Soultions
Download

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.