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Bethesda North Marriott Hotel and Conference Center

Feb 05, 2018 7:00 AM - Feb 07, 2018 3:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Overview

February 4: Primer Course
February 5: Short Courses
February 5-7: Forum

At the Regulatory Submissions, Information, and Document Management Forum, 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. Tracks include:

  • RIM Business track addresses processes for obtaining and managing regulatory information, organizational impact, and key issues shaping the global regulatory and business environments.
  • RIM Technology track focuses on standards related to submission of regulatory information, tools to effectively manage the information, implementation experiences and results, and implications for refinement.
  • Electronic Regulatory Submissions (ERS) track explores the submission process, regulatory requirements and new developments, best practices in regulatory submissions and industry adoption techniques.
  • Electronic Document Management (EDM) track examines the processes, systems, and best practices for content management across the product lifecycle, including alignment with the RIM system for optimal use of regulatory information.

View all sessions.

TWO On-Demand Webinars

EDM and ERS - Hot Topics and Tools of the Trade
This webinar will address current hot topics impacting EDM and ERS. A high-level overview of the various tools and process’s which are required for the effective and efficient operation of an organizations quality regulated content and document/submission publishing.
Register today!

Enterprise Ontology Approach to System Implementation and Process Development to Minimize Organizational Disruption
This webinar will explore how these methods, based on the work by Professor Jan Dietz, can be used to facilitate the implementation of system changes in various use cases in the biopharmaceutical industry.
Register today!

Preconference Short Courses on February 4-5

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Continuing-Education

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Exhibits

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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)
  • Estimate the scope and 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

Short Course or Primer

To keep you at the forefront.

Feb 05, 2018

Course 1:

Global Identification of Medicinal Products

Learn more

Feb 05, 2018

Course 2:

Essentials for Compiling/Publishing Compliant Electronic Submissions (eCTDs)

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Feb 04, 2018

Regulatory Content and Submissions Primer:

Tracking Content from Conception to Interment

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Program Committee

  • Brooke Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Vice President, Engagement and Growth
    Accumulus Synergy, United States
  • Michelle L. Charles, MPH
    Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program
    University of Pennsylvania, Perelman School of Medicine, United States
  • Jamie Toth, MS
    Jamie Toth, MS Global Head, TMF Management & Records
    Beigene, United States
  • Venkatraman Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
    Orion Innovation, United States
  • Cindy Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Jake Doran
    Jake Doran Head of Digital
    MAPS Public Benefit Corporation (MAPS PBC), United States
  • Betsy Fallen, RN
    Betsy Fallen, RN Consultant
    BAFallen Consulting LLC, United States
  • Mark A. Gray
    Mark A. Gray Senior Project Manager, DSB, CBER
    FDA, United States
  • Ginny Hussong
    Ginny Hussong Branch Chief, Data Standards, CBER
    FDA, United States
  • Thomas Noto
    Thomas Noto Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Daniel Orfe, MS
    Daniel Orfe, MS President and CEO
    Regulatory eSubmissions, LLC, United States
  • Sarah Powell, RAC
    Sarah Powell, RAC President
    Powell Regulatory Services, United States
  • Vikesh Srivastava
    Vikesh Srivastava Associate Director, Business Informatics Division, HPFB
    Health Canada, Canada
  • Michiel Stam
    Michiel Stam Director Regulatory Information Management
    Qdossier - A Celegence Company, Netherlands
  • Stacy Tegan
    Stacy Tegan Program Director
    Transcelerate Biopharma, Inc., United States
  • Peter Terbeek, MBA
    Peter Terbeek, MBA Senior Director, Regulatory Operations
    Astellas, United States
  • Ron Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of the Director, CBER
    FDA, United States

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