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Overview

February 13-15: Forum


CALL FOR ABSTRACTS

Have a great idea or a case study you wish to share? It's that time of year again!

We are looking for presentation, session, and short course abstracts at this time—the submission deadline is Friday, August 12. A deep list of suggested topics can be found on our Abstract Guidelines and include areas that fall under three major categories.

  • Regulatory Informatics
  • Electronic Regulatory Submissions (ERS)
  • Trial Master File (TMF) Inspection Readiness and Electronic Document Management (EDM)

Submit




NEW for 2023 – CALL FOR TOPICS (FDA)!

We have the pleasure of hosting plenary sessions delivered by members of the US Food and Drug Administration (FDA) at this Forum. They want to hear from YOU what you want to hear from THEM! Visit our Call for Topics to brainstorm together as we aim to gain a better understanding of your professional needs and the type of content DIA, and the FDA should focus on for the DIA 2023 RSIDM Forum program agenda. the submission deadline is Friday, August 12

Submit




The last few years has 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. The Forum presents four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Electronic Document Management, and Electronic Regulatory Submissions. Cross-track sessions provide the opportunity to discuss key connection points across major components of regulatory information, and plenary sessions featuring regulatory intelligence updates by FDA and other regulatory authorities are offered each day.

This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.

Social distancing measures may be in place at the time of the event. Therefore, we encourage you to register and make your housing arrangements early due to potential limited capacity. Don’t miss out on your chance to meet live again with your friends and colleagues!

While we work on our 2023 Agenda, please view our 2022 FINAL PROGRAM!

Participant Testimonials

“Extremely useful event for any regulatory professional, or vendor providing solutions in the space. Unique opportunity to discuss solutions and industry topics with others in the industry. Can't recommend the event highly enough.” - Paul Ireland – DocShifter

“Experts from all over the world generously shared their experiences, their lessons learned, and their recommendations for what we can do now and into the future. I highly recommend this event!” - Regina Lynn Preciado, Content Rules, Inc.

Who should attend?

Professionals involved in:

  • Regulatory Affairs and Operations
  • Regulatory Information Management
  • Regulatory Informatics
  • Global Submission/Project Management
  • Medical, Technical, and Regulatory Writing
  • Data Management
  • Information Technology and Support
  • Document and eRecords Management
  • Essential Document Process and Business Systems
  • Regulatory Standards Implementation
  • Clinical Operations
  • Quality Assurance and Compliance
  • Contract Researchers and Service Support
  • Emerging Pharmaceutical/Biotech/Device
  • Vendor Relationship Management

Program Committee

  • Jake  Doran
    Jake Doran Head of Global R&D IT
    Bausch Health, United States
  • Jo  English
    Jo English Vice President, Regulatory Information Management
    Calyx, United Kingdom
  • Vahe  Ghahraman, PhD
    Vahe Ghahraman, PhD Senior Director, Global Regulatory Operations Head
    Apellis Pharmaceuticals, Inc. , United States
  • Kristen  Sauter, MBA
    Kristen Sauter, MBA Director, Global Regulatory Informatics & Analytics
    Takeda Pharmaceuticals, United States
  • Cary  Smithson, MBA
    Cary Smithson, MBA Director Regulatory Solutions
    Phlexglobal, United States
  • Katherine  Novak, MS
    Katherine Novak, MS Senior Advisory Consultant, Regulatory Affairs
    NNIT, United States
  • Alison  Buno, MBA
    Alison Buno, MBA Sr. Director, Regulatory Submissions
    Abbvie, Inc., United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Joanne  Malia, MS, MSc
    Joanne Malia, MS, MSc Director, Clinical Documentation Management
    Regeneron Pharmaceuticals, United States
  • Jamie  O'Keefe
    Jamie O'Keefe Vice President, Business and Technology Consulting
    Just in Time GCP, United States
  • Joel  Finkle
    Joel Finkle Associate Director, Regulatory Information Management
    BeiGene, United States
  • Sandra  Krogulski, MA
    Sandra Krogulski, MA Associate Director, Submission Management
    Bristol-Myers Squibb Company, United States
  • Rob  Labriola, MS
    Rob Labriola, MS Exec. Director, Regulatory Operations
    Synchrogenix, United States
  • Daniel  Offringa
    Daniel Offringa Principal Consultant
    eSub Solutions, United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States
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