Overview
February 6: Short Course
February 8: Short Course
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.
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
Session 1: Keynote Address : Fostering Trustworthy and Responsible AI
The Keynote has Been Released! Reggie Townsend, MBA, Vice President, Data Ethics, SAS
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Short Course or Primer
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Program Committee
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Jo English Vice President, Regulatory Information Management
Calyx, United Kingdom -
Sandra Krogulski, MA Director, GRSO Innovation and Business Operations Lead
Bristol-Myers Squibb Company, United States -
Ethan Chen, MBA, MS, PMP Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
FDA, United States -
Rob Labriola, MS Exec. Director, Regulatory Operations
Garuda Therapeutics, United States -
Jamie O'Keefe Head, Clinical and Regulatory Consulting Services
Astrix Technology, Inc, United States -
Alison Buno, MBA Senior Director, Regulatory Submissions
AbbVie, Inc., United States -
Jillian E. Carinci, MS Senior Director, Head of Submission Sciences
Biogen, United States -
Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States -
Joel Finkle Industry Expert
Retired, United States -
Vahe Ghahraman, PhD Senior Director, Global Regulatory Operations Head
Apellis Pharmaceuticals, Inc. , United States -
Dominik Gigli Management Consultant
Main5 GmbH & Co. KGaA, Germany -
Jared Lantzy Sr. Director, Global Regulatory Operations
Novavax, Inc., United States -
Teresa Martins Senior Director, US Site Head Regulatory Submission Management
Bayer U.S. LLC, United States -
Katherine Novak, MS Principal Product Manager
Accumulus Synergy, United States -
Daniel Offringa Principal Consultant
eSub Solutions, United States -
Neel Patel, MS Principal Consultant
Red Nucleus, United States -
Nimesh Patel Director of Global Regulatory Systems & Operations
Eisai Pharmaceuticals, United States -
Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
FDA, United States -
Maria Sagoua Director of Regulatory Innovation
Accumulus Synergy, United States -
Kristen Sauter, MBA Director, Global Regulatory Informatics & Analytics
Takeda Pharmaceuticals, United States -
Matthias Sijtstra Senior Regulatory Data Specialist
Qdossier, A Celegence Company, Canada -
Cary Smithson, MBA Senior Director, Business Transformation & Systems Management
PharmaLex, United States -
Representative Invited DIA, United States
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