Overview
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. This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.
While we develop our 2024 Agenda, please take a moment to review our 2023 FINAL PROGRAM!
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, CBDER, 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.
Featured
Who should attend?
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Meeting Designed For
Join professionals from every corner of the vast realm of real-world data and real-world evidence:
- 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
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 -
Alison Buno, MBA • Sr. 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 • Associate Director, Regulatory Information Management
BeiGene, 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 -
Rob Labriola, MS • Exec. Director, Regulatory Operations
Garuda Therapeutics, United States -
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 • Senior Advisory Consultant, Life Sciences
NNIT, United States -
Daniel Offringa • Principal Consultant
eSub Solutions, United States -
Jamie O'Keefe • Head, Clinical and Regulatory Services
Astrix Technology, Inc, 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, Regulatory; R&D Digital Transformation
Pharmalex, United States
