概览

February 2-4: 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. Our Forum brings a 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.

While we develop our 2026 Agenda, please take a moment to review our 2025 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.

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谁应该参加？

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

学习目标

At the completion of this conference, the participant should be able to:
- Describe current global trends and regulatory initiatives impacting regulatory submissions, information, and document management
- Explain how evolving standards (e.g., eCTD 4.0, structured content, IDMP) and digital technologies (cloud, AI, automation) are transforming regulatory processes and expectations
- Identify practical strategies to improve regulatory data and content quality, governance, and interoperability across systems and functions
- Apply insights from global regulators, industry case studies, and cross-functional collaborations to enhance their organization’s regulatory operating models and readiness for future change

项目委员会

Jillian E. Carinci, MS Senior Director, Head of Submission Sciences
Biogen, United States
Maria Sagoua, MHA
United States
Jared Lantzy, PMP Executive Director, Global Regulatory Operations
Novavax, United States
Noelia Plaza Director of Process Excellence & Analytics
Daiichi Sankyo, United States
Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
FDA, United States
Rita Algorri, PhD, MS Associate Director, Global Regulatory Affairs (CMC)
Amgen, United States
Venkatraman Balasubramanian, PhD, MBA Healthcare and Life Sciences Strategic Advisor
VB Insights, LLC, United States
Rachel Bombara Sr. Regulatory Services Manager
Certara, United States
Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., United States
Jennifer Dames Director, RA Submission Management
AbbVie, United States
Lindsay Fitzgerald Delivery Manager
Astrix, United States
Shenqi (Handsome) Ji Publishing Regional Director, Asia, Global Regulatory & International Operations
Pfizer, China
Kunal Lal, MBA Consultant - Strategy & Change
Red Nucleus, United Kingdom
Lorelle Leonienco, PMP Product Manager
LORENZ Life Sciences Group, United States
Aliza Nathoo Senior Director, Content Strategy
F. Hoffmann-La Roche Ltd., Canada
Katherine Novak, MS Director
Epista Life Science, United States
Nimesh Patel Director of Global Regulatory Systems
Eisai Co., Ltd., United States
Vladimir Penkrat, MBA Associate Vice President – Regulatory Affairs
Indegene, United States
Theresa Pinnell, MLS Director of Regulatory Solutions
Kivo, United States
Matthias Sijtstra Senior Consultant
Main5 GmbH & Co. KGaA, Netherlands
Kevin Tompkins, MBA Executive Director, Regulatory Information & Submission Management
Bristol Myers Squibb, United States
Seyoum Senay, MS Supervisory Operations Research Analyst, CDER/OBI
FDA, United States
Representative Invited DIA, Switzerland

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Regulatory Submissions, Information, and Document Management Forum

概览

Participant Testimonials

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Exhibits

Highlights & Features