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Tutorial:  May 11th
Meeting:  May 11th-13th

Virtual Event:  Click here for details. 

EDM and ERS is combining with RIM in 2015 for the eRegulatory and Intelligence Annual Conference. 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.   

The program committee is developing this conference featuring plenary sessions on latest trends in the industry as well as FDA and other Agency updates for direct dialogue with industry. This conference serves as a forum for the discussion of emerging standards and the processes for submission creation and maximum use of regulatory information. The highly appreciated "Ask the Regulators Session" will be augmented by "Ask the Industry Experts" sessions to provide avenues of two way discussions of hot topics with the Regulators, industry experts and audience participants (questions can be submitted ahead of time).

Sessions are separated into four tracks. 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, respectively. 

As the eRegulatory and intelligence space emerges, it is critical to break down silos for end to end processing of regulatory information as it relates to EDM and ERS.  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 new combined program aims to incorporate all relevant topics from the previous separate conferences without sacrificing focus.

This program is being developed in collaboration with the Document and Records Management and Electronic Regulatory Submissions Communities.

Featured topics

  • Cross-functional sessions dedicated to the different areas of interest
  • Networking opportunities (reception, interaction with global regulators, cross-disciplinary networking)
  • Presentation of best practices
  • Exhibit hall
  • Interactive/collaborative sessions to share and develop ideas and experience
  • Learn from experiences of colleagues
  • New “Ask the Industry Experts” panel
  • Interact with Agency personnel

Who should attend?

Professionals who are involved in:

  • Regulatory Affairs and Operations
  • Regulatory Information Management
  • Global Submission Managers/Project Managers
  • Data Managers
  • Information Technology and Support Personnel
  • Document and eRecords Managers
  • 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 conference, 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 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
  • Sarah  Powell, RAC
    Sarah Powell, RAC President
    Powell Regulatory Services, United States
  • Kimberly  Belsky, MS
    Kimberly Belsky, MS Executive Director, Regulatory Policy and Intelligence, Regulatory Affairs
    Mallinckrodt Pharmaceuticals, United States
  • Jake  Doran
    Jake Doran Head of Global R&D IT
    Bausch Health, United States
  • Betsy  Fallen, RN
    Betsy Fallen, RN Consultant
    BAFallen Consulting LLC, United States
  • Mark A. Gray
    Mark A. Gray Senior Project Manager, DSS, CBER
    FDA, United States
  • Ginny  Hussong
    Ginny Hussong Chief, Data Standards Program, CBER
    FDA, United States
  • Dominique  Lagrave, PharmD
    Dominique Lagrave, PharmD Director, Global Regulatory Affairs and Safety Operations
    Amgen, United States
  • Daniel  Orfe, MS
    Daniel Orfe, MS President and CEO
    Regulatory eSubmissions, LLC, United States
  • Emily  Onkka
    Emily Onkka Senior Director, Regulatory Affairs
    Pfenex, Inc., United States
  • Laura J. Sherman, MBA
    Laura J. Sherman, MBA Training Partner, Clinical Business Operations
    Vertex Pharmaceuticals, Inc., United States
  • Stacy  Tegan
    Stacy Tegan Senior Program Manager
    Transcelerate Biopharma Inc., United States
  • Hans  van Bruggen, MSc
    Hans van Bruggen, MSc CEO and Senior RA Consultant
    Qdossier, Netherlands
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Contact us

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Registration Questions
Customer Service
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET

Agenda Details
Carrie Dunn, Content Lead
Phone +1.215.442.6181
Fax +1.215.442.6199

Event Logistics
Stephanie Ritter, Event Planner
Phone +1.215.442. 6149
Fax +1.215.442.6199

Exhibit Details
Jessica Culp, Exhibit & Event Logistics Associate 
Phone +1.215.442. 6132
Fax +1.215.442.6199 

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