Overview
Short Course: February 9, 2023 | Virtual
Short Course: February 10, 2023 | Virtual
Primer: February 12, 2023 | In-Person
February 13-15: 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. The Forum presents four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Trial Master File (TMF) Inspection Readiness and 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.
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.
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Featured
Short Course or Primer
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Feb 12, 2023
Regulatory Content and Submission Primer: Content from Authoring to Archive
Learn more -
Feb 09, 2023
Short Course: The Future of Documents: Deep-Dive into Structured Content
Learn more -
Feb 10, 2023
Short Course: On the Road to an EU Filing: Getting Familiar with Critical EMA IT Systems
Learn more
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
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Learning Objectives
At the conclusion of this activity, participants should be able to:
- Explain and gain insights on regulatory updates from global regulatory health authorities
- Apply insights from the PDUFA reauthorization and explain selected key data standards initiatives for the US
- Describe eCTD v4.0 and its implementation in various regions
- Identify KPI metrics to demonstrate RIM performance and describe a valuable roadmap to high RIM performance
- Identify how advanced technologies can be applied to impact functions and processes within regulatory affairs
- Describe the key requirements for regulatory submissions in Brazil, China, Europe, Japan, and the US
- Recognize common electronic submission errors and identify tools and techniques to avoid and/or solve them
- Describe and understand how team collaboration and an effective team strategy achieve submission goals
- Describe the practicalities and benefits of structured content management
- Identify practical aspects of implementing content authoring automation for regulatory submission documents and the process improvements needed to streamline those processes
- Apply insights and implementation guidelines to increase IDMP adoption success
- Discuss approaches for implementing and scaling intelligent automation technologies, the value in doing so, and how to deal with challenges along the way
- Evaluate the impacts of digital transformation on the regulatory workforce
- Evaluate how to gain intelligent insights from aggregated data
- Describe the key elements of establishing a data governance program, the approaches to data unification and its sustainability without system integration, and the impact of implementing RIMS with poor data quality
- Describe the current deliverables and the latest developments on the ICH M11 guideline, protocol template and technical specification
Program Committee
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Michiel Stam • Director Regulatory Information Management
Qdossier - A Celegence Company, Netherlands -
Karen McCarthy Schau • Director, Risk-based Study Management
Vertex Pharmaceuticals, United States -
Stacy Tegan • Program Director
Transcelerate Biopharma Inc., United States -
Ethan Chen, MBA, MS, PMP • Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
FDA, United States -
Jake Doran • Head of Digital
MAPS Public Benefit Corporation (MAPS PBC), 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 • Senior Director, Regulatory; R&D Digital Transformation
Pharmalex, United States -
Katherine Novak, MS • Senior Advisory Consultant, Life Sciences
NNIT, United States -
Alison Buno, MBA • Sr. Director, Regulatory Submissions
Abbvie, Inc., United States -
Joanne Malia, MS, MSc • Director, Development Records Management
Regeneron Pharmaceuticals, United States -
Jamie O'Keefe • Head, Clinical and Regulatory Services
Astrix Technology, Inc, United States -
Joel Finkle • Associate Director, Regulatory Information Management
BeiGene, United States -
Sandra Krogulski, MA • Director, GRSO Innovation and Business Operations Lead
Bristol-Myers Squibb Company, United States -
Rob Labriola, MS • Exec. Director, Regulatory Operations
Garuda Therapeutics, United States -
Daniel Offringa • Principal Consultant
eSub Solutions, United States -
Jonathan Resnick, PMP • Project Management Officer, OBI, OSP, CDER
FDA, United States -
Representative Invited • DIA, United States
Contact us
Registration Questions?
On-Demand Content Preview Webinar
Preconference Primer
Regulatory Content and Submission Primer: Content from Authoring to Archive
Preconference Short Courses
Short Course: The Future of Documents: Deep-Dive into Structured Content
Short Course: On the Road to an EU Filing: Getting Familiar with Critical EMA IT Systems
Additional Information
Discover DIA’s Live In-Person EventsRegulatory Submissions, Information, and Document Management Forum Resource Kit
Download and fill out our Justification Letter
