February 13-15: Forum
CALL FOR ABSTRACTSHave 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)
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
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!
“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
Jake Doran • Head of Global R&D IT
Bausch Health, United States
Jo English • Vice President, Regulatory Information Management
Calyx, United Kingdom
Vahe Ghahraman, PhD • Senior Director, Global Regulatory Operations Head
Apellis Pharmaceuticals, Inc. , United States
Kristen Sauter, MBA • Director, Global Regulatory Informatics & Analytics
Takeda Pharmaceuticals, United States
Cary Smithson, MBA • Director Regulatory Solutions
Phlexglobal, United States
Katherine Novak, MS • Senior Advisory Consultant, Regulatory Affairs
NNIT, United States
Alison Buno, MBA • Sr. Director, Regulatory Submissions
Abbvie, Inc., United States
Cindy Chiu • Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States
Joanne Malia, MS, MSc • Director, Clinical Documentation Management
Regeneron Pharmaceuticals, United States
Jamie O'Keefe • Vice President, Business and Technology Consulting
Just in Time GCP, United States
Joel Finkle • Associate Director, Regulatory Information Management
BeiGene, United States
Sandra Krogulski, MA • Associate Director, Submission Management
Bristol-Myers Squibb Company, United States
Rob Labriola, MS • Exec. Director, Regulatory Operations
Synchrogenix, United States
Daniel Offringa • Principal Consultant
eSub Solutions, United States
Jonathan Resnick, PMP • Project Management Officer, OBI, OSP, CDER
FDA, United States