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Overview

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

Regulatory information is arguably the most valuable asset of a pharmaceutical, biotech, or medical device company. It includes data, meta-data, documents and other forms of information about regulatory and submission intelligence, regulatory authority submission and reporting requirements, submission plans for new products and life cycle management activities, as well as product registration information, labeling, CMC, and safety submissions, communications from health authorities, and more

How regulatory information is managed has a profound impact on operational efficiency across the whole organization, on data quality, and ultimately on the company’s ability to meet the needs of patients. As global regulatory requirements, technology, data sources, and data standards evolve, the importance of sound regulatory information management becomes even greater.

DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum brings together industry and regulatory stakeholders working across the scope of regulatory information to examine current data standards and requirements and effective regulatory information management approaches to align related systems. The Forum presents four tracks: Regulatory Information Management (RIM) Business, RIM 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.

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

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 Senior Director, R&D Consulting
    NNIT, 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  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of the Director, 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 Head of Global R&D IT
    Bausch Health, United States
  • Ginny  Hussong
    Ginny Hussong Chief, Data Standards Program, CBER
    FDA, United States
  • Joanne S. Malia, MS, MSc
    Joanne S. 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
  • Thomas  Noto
    Thomas 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 Head of Data Management and Regulatory Information Scientist
    Qdossier, 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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