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Overview

February 9: Primer
February 10: Short Courses
February 10-12: Forum


At the core of improving processes and building efficiencies is better organization and management of the data used in processes throughout the product lifecycle, an effort that can be complex and challenging under the best of circumstances.

DIA’s Regulatory Submissions, Information, and Document Management Forum provides the elements needed to meet the challenges of optimizing the efficient use of regulatory information: the RIM principles, effective processes and tools, benefits to data applications across the product lifecycle, and examination of real-life results. DIA will present four tracks and daily health authority plenary sessions to provide a comprehensive view of content and regulatory information management and submissions. All tracks are supported with daily plenary sessions providing regulatory intelligence updates by health authority representatives from FDA, Health Canada, and other regions of interest.

This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business- and technology-focused attendees.


Who should attend?

Professionals involved in:

  • Regulatory Affairs and Operations
  • Regulatory Information Management
  • 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

Learning objectives

At the conclusion of this forum, participants should be able to:

  • Explain the regulatory electronic submission process from the completion of its upload to the Electronic System Gateway (ESG) through the time the submission is made available to the review team
  • Discuss the agency target time frames for the 1) expected submission upload duration(s) and 2) timeframe between key milestones and notifications
  • Describe the current required data standards for regulatory submissions and the status of ongoing data standards initiatives
  • Describe organizational processes and governance to ensure integrity, quality, and security of regulatory information (data, documents, records)
  • Examine the scope and assess the future of data standards, including IDMP, with respect to systems, processes, and master data
  • Discuss ways data can be harmonized, integrated, and viewed to provide an end-to-end view of the regulatory information value chain
  • Discuss organizational implications related to increasing electronic interactions with stakeholders and health authorities
  • Explain ways to improve processes and communication of regulatory activities including communications, end-to-end processes, and integration of systems for document, submission, and records management
  • Interpret global health authority regulations and guidances for systems and business processes
  • Identify ways in which the integration of data, documents, and knowledge can be leveraged to develop insights and enable better business decisions
  • Identify changes in submission-related regulations impacting RIM business processes

Program Committee

  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Head, Regulatory Information Management
    Beigene, United States
  • Michelle L. Charles, MPH
    Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center
    University of Pennsylvania, Perelman School of Medicine, United States
  • Cindy  Chiu
    Cindy Chiu Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Ron D. Fitzmartin, PhD, MBA
    Ron D. Fitzmartin, PhD, MBA Senior Informatics Advisor, OD, CBER
    FDA, United States
  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA Senior Vice President, Life Sciences
    Orion Business Innovation, United States
  • Danielle  Beaulieu, PhD
    Danielle Beaulieu, PhD Group Director, Global Regulatory Business Capabilities
    Bristol-Myers Squibb, United States
  • Ethan  Chen, MBA
    Ethan Chen, MBA Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
    FDA, United States
  • Jake  Doran
    Jake Doran Chief Technology Officer
    Genpact, United States
  • Virginia  Hussong
    Virginia Hussong Chief, Data Standards Program, CBER
    FDA, United States
  • Joanne S. Malia
    Joanne S. Malia Director, Clinical Documentation Management
    Regeneron Pharmaceuticals, United States
  • Karen  McCarthy Schau
    Karen McCarthy Schau Director, Adaptive Monitoring
    Vertex Pharmaceuticals, United States
  • Thomas J. Noto
    Thomas J. Noto Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Daniel F. Orfe, MS
    Daniel F. Orfe, MS President and CEO
    Regulatory eSubmissions, LLC, United States
  • Michiel  Stam
    Michiel Stam Regulatory Information Scientist
    Qdossier B.V., Netherlands
  • Stacy  Tegan
    Stacy Tegan Senior Program Manager
    Transcelerate Biopharma Inc., United States
  • Peter  Terbeek, MBA
    Peter Terbeek, MBA Senior Director, Publishing and Submission
    Astellas, United States
  • Kevin  Tompkins, MBA, MS
    Kevin Tompkins, MBA, MS Group Director, Global Lead, Global Dossier Management
    Bristol-Myers Squibb, United States
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