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February 8 - Tutorial (AM)*
February 8-10 - Forum

Tutorial - IDMP: "Start Early, Finish Strong"

*Tutorials require registration and are an additional fee

EDM, ERS, and RIM have combined for the 2016 Regulatory Submissions, Information, and Document Management Forum. This forum will cover topics in four tracks: Electronic Regulatory Submissions (ERS), Regulatory Information Management (RIM) Business, RIM Technology, and Electronic Document Management (EDM).

In recent years, industry as a whole has been converging towards looking at regulatory as an end-to-end process. Document management, publishing, and technical regulatory requirements are all subsets of regulatory information management at its broadest definition. This course of managing documents starts at the creation of that document as part of the clinical trial. This conference serves as a forum for the discussion of emerging operational standards, best practices and the processes for submission, creation, and maximum use of regulatory information. The conference continues to explore information generated along the drug development continuum life cycle and alignment to ever evolving regulatory and electronic standards. The RIM business focused track provides the opportunity to interact and share experiences related to processes for obtaining and managing regulatory information and the organizational impact as well as gain a greater understanding of key issues shaping the global regulatory environment. The technology track will focus on standards related to submission of regulatory information, the tools necessary to effectively manage the information, and associated implementation experiences and lessons learned. The traditional ERS and EDM tracks will focus on emerging trends and best practices in regulatory submissions and electronic document management life cycle, respectively.

Lessons learned from recent mergers have highlighted the importance of regulatory intelligence as well as efficient systems and processes. Many people and companies define RIM differently, but maximizing access to information is critical to gain efficiencies and remain competitive. This year’s combined program aims to incorporate all relevant topics from the previous separate conferences without sacrificing focus.

As the Essential Documentation is created, reviewed, and approved via workflows and stored in electronic document repositories, the adoption of best practices and standards are critical to ensuring compliance and efficiency. As these repositories are subject to regulatory inspection, both at the Sponsor/CRO and the clinical site, practices of all stakeholders are transitioning to offer consistency while maintaining patient safety.

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Who should attend?

Professionals who are involved in:

  • Regulatory Affairs and Operations
  • Regulatory Information Management
  • Global Submission Managers/Project Managers
  • Medical, Technical, and Regulatory Writers
  • Data Managers
  • Information Technology and Support Personnel
  • Document and eRecords Managers
  • Essential Document Process and Business System Owners
  • Regulatory Standards Implementation Specialists and Associates
  • Clinical Operations Representatives
  • Quality Assurance and Compliance Professionals
  • Contract Researchers and Service Support Providers
  • Emerging Pharmaceutical/Biotech/Device Professionals
  • Vendor Relationship Managers

Learning objectives

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

  • Describe organizational processes and governance to ensure integrity, quality, and security of records
  • Discuss how to break down silos for end to end processing of regulatory information as it relates to EDM and ERS
  • Envision the scope and future of IDMP with respect to systems, process, standards and master data
  • Discuss organizational implications related to increasing electronic interactions with stakeholders
  • Explain ways to implement processes to improve reporting of regulatory expectations and communications
  • Interpret global health authority regulations and guidance’s for systems and processes
  • Describe how to map eTMF capabilities to support clinical site inspections
  • Identify techniques to create efficiencies in the overall end to end process of document and submission management

Program Committee

  • Christian A. Buckley, MBA, RAC
    Christian A. Buckley, MBA, RAC Associate Director, Regulatory Affairs
    Astellas, United States
  • Betsy  Fallen, RN
    Betsy Fallen, RN Consultant
    BAFallen Consulting LLC, United States
  • Sarah  Powell, RAC
    Sarah Powell, RAC President
    Powell Regulatory Services, United States
  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Associate Vice President, Regulatory and Clinical
    NNIT, Inc., 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
  • Jake  Doran
    Jake Doran Head of Digital
    MAPS Public Benefit Corporation (MAPS PBC), United States
  • Ron  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of Regulatory Operations, CBER
    FDA, United States
  • Mark A. Gray
    Mark A. Gray Senior Project Manager, DSB, CBER
    FDA, United States
  • Virginia  Hussong
    Virginia Hussong Chief, Data Standards Program, CBER
    FDA, United States
  • Andrew  Marr, PhD
    Andrew Marr, PhD Managing Director
    Marr Consultancy Ltd, United Kingdom
  • Thomas  Noto
    Thomas Noto Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Daniel  Orfe, MS
    Daniel Orfe, MS President and CEO
    United States
  • Michiel  Stam
    Michiel Stam Director Regulatory Information Management
    Qdossier - A Celegence Company, Netherlands
  • Stacy  Tegan
    Stacy Tegan Program Director
    Transcelerate Biopharma Inc., United States
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