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Overview

Primer: February 4
Short Courses: February 5
Main Forum: February 8

The global COVID-19 pandemic has had 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 systems. 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.

The program has been released! Preview all session descriptions, speakers, and more all in one place! View Program



Watch the video below for a full Virtual Conference Site Tour! Navigate the agenda, learn how to schedule 1:1 meetings, explore the exhibit hall, and more!


Hear from two members of the Program Committee about the exciting content being offered this year!


Featured topics

  • Lessons Learned from Preparing and Submitting an IND Application for a COVID-19 Treatment Candidate
  • FDA’s Strategy on Data and Technology and their Response to the Rapidly Changing Healthcare Environment
  • Significant Global eCTD Specification Changes
  • IDMP Readiness and the Emerging Global Picture for Structured Data Acceptance
  • How Automation can Improve Health Authority Communication and Regulatory Strategy
  • The AdPromo eCTD Process
  • Mergers and Acquisitions in Pharma
  • Emerging Technologies and Data Driven Initiatives within the Regulatory Environment
  • The Crossroads Between Regulatory and Safety
  • Industry Data on Benefits of a Strong Regulatory Information Management Strategy
  • eTMF Collaboration in Outsourced Studies

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

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 Regulatory Informatics business processes

Program Committee

  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Director
    NNIT Inc., United States
  • Cindy  Chiu
    Cindy Chiu Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Peter  Terbeek, MBA
    Peter Terbeek, MBA Senior Director, Publishing and Submission
    Astellas, United States
  • Ron  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of the Director, CBER
    FDA, United States
  • Thomas  Noto
    Thomas Noto Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA Senior Vice President, Life Sciences
    Orion Innovation, United States
  • Jo  English
    Jo English Vice President, Regulatory Information Management
    Calyx, United Kingdom
  • Jake  Doran
    Jake Doran Head of Global R&D IT
    Bausch Health, United States
  • Michiel  Stam
    Michiel Stam Head of Data Management and Regulatory Information Scientist
    Qdossier, Netherlands
  • Danielle  Beaulieu, PhD
    Danielle Beaulieu, PhD Senior Director, Global Regulatory Business Capabilities
    Bristol-Myers Squibb, United States
  • Joanne  Malia, MS, MSc
    Joanne Malia, MS, MSc Director, Clinical Documentation Management
    Regeneron Pharmaceuticals, United States
  • Karen  McCarthy Schau
    Karen McCarthy Schau Director, Global Clinical Operations
    Vertex Pharmaceuticals, United States
  • Daniel  Orfe, MS
    Daniel Orfe, MS President and CEO
    Regulatory Esubmissions, LLC, United States
  • Stacy  Tegan
    Stacy Tegan Senior Program Manager
    Transcelerate Biopharma Inc., United States
  • Kevin  Tompkins, MBA
    Kevin Tompkins, MBA Senior Director, Global Submission Management
    Bristol Myers Squibb, United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States
  • Virginia  Hussong
    Virginia Hussong Chief, Data Standards Program, CBER
    FDA, United States
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