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Overview

February 5: Regulatory Content and Submissions Primer: Tracking Content from Conception to Interment*
February 6: 
Short Courses (AM)*
February 6-8: Forum

Short Course 1: Global Identification of Medicinal Products (IDMP)
Short Course 2: Achieving Regulatory Operations Excellence Through Outsourcing

*Primer and Short Courses require separate registration.


DIA is proud to present the Regulatory Submissions, Information, and Document Management Forum. This forum was initially three separate DIA meetings: EDM (Electronic Document Management), ERS (Electronic Regulatory Submissions), and RIM (Regulatory Information Management), each with their own unique histories. In 2015, those three meetings were combined into one forum in an effort to represent the end-to-end process of managing regulatory submissions and documents. The response to this approach has been incredibly positive with record attendance in 2016, as it serves as the premier place for the discussion of emerging operational standards, best practices, and the processes for submission, creation, and maximum use of regulatory information. The forum 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 RIM 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.


Dinner on the Town | Tuesday, February 7 | 6:00PM

Wait, Wait, Don’t Tell Me! Your Regulatory War Stories
Moderated by Matt Neal and Sheila Mahoney-Jewels, hear individuals briefly share their regulatory war stories. Take a break from rigorous educational content while still ensuring time well spent. This night is designed to ensure that you leave in good humor, and feeling much better about your own regulatory histories.
(Dinner cost is on your own.)

Sign up using this link.


Highlights

  • Latest updates on PDUFA V and a preview of PDUFA VI
  • Get answers to all your imerative questions from FDA leaders during the Ask the FDA Session
  • Exhibit Hall with more than 30 vendors sharing their new solutions and services
  • Multiple networking opportunities

Featured topics

  • Electronic Document Management
  • Electronic Regulatory Submissions
  • Regulatory Information Management for Businesses
  • Regulatory Information Technical Management
  • Identification of Medicinal Products (IDMP)
  • Structured Authoring
  • eTrial Master File

Who should attend?

Professionals involved in:

  • Regulatory Affairs and Operations
  • Regulatory Information Management
  • Global Submission/Project Managment
  • 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:

  • 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 communication of regulatory expectations and communications
  • Interpret global health authority regulations and guidances 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

  • Michelle L. Charles, MPH
    Michelle L. Charles, MPH Manager, Regulatory Implementation
    PAREXEL International, United States
  • Virginia  Hussong
    Virginia Hussong Data Standards Program Manager, OD, BSS, CBER
    FDA, United States
  • Sarah  Powell, RAC
    Sarah Powell, RAC President
    Powell Regulatory Services, United States
  • Jamie Marie Toth, MS
    Jamie Marie Toth, MS Director TMF Operations
    Daiichi Sankyo, Inc., United States
  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA President and CEO
    Cabeus, Inc., United States
  • Christian A. Buckley, MBA, RAC
    Christian A. Buckley, MBA, RAC Associate Director, Regulatory Affairs
    Astellas, United States
  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Partner, Business Operations
    Identifica, United States
  • Cindy  Chiu
    Cindy Chiu Director, Regulatory Affairs Operations & Quality Management
    Merck & Co., Inc., United States
  • Jake  Doran
    Jake Doran Founder, Managing Director
    List Innovations, LLC, United States
  • Betsy  Fallen, RN
    Betsy Fallen, RN Consultant
    BAFallen Consulting LLC, United States
  • Ron D. Fitzmartin, PhD, MBA
    Ron D. Fitzmartin, PhD, MBA Senior Advisor, Office of Strategic Programs, CDER
    FDA, United States
  • Mark A. Gray
    Mark A. Gray Senior Project Manager, BSS, CBER
    FDA, United States
  • Dominique  Lagrave, PharmD
    Dominique Lagrave, PharmD Director, Global Regulatory Affairs and Safety Operations
    Amgen, United States
  • Thomas J. Noto
    Thomas J. Noto Sr. Director, Regulatory Operations
    United States
  • Daniel F. Orfe, MS
    Daniel F. Orfe, MS President & CEO
    Regulatory eSubmissions, LLC, United States
  • Vada A. Perkins, BSN, MS, MSc, RN
    Vada A. Perkins, BSN, MS, MSc, RN Identifica, LLC
    Identifica, LLC, United States
  • Michiel  Stam
    Michiel Stam Regulatory Information Scientist
    eCTDconsultancy B.V., Netherlands
  • Stacy J. Tegan
    Stacy J. Tegan Manager, Regulatory Technology Consulting
    Accenture Accelerated R&D Services, United States
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