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Overview

Primer
Short Courses
February 14-16: Forum

The last few years has shed light on the importance of operational efficiency of the management of regulatory information to ensure quality regulatory submission to health authorities. We have seen how the ability to perform at this level has allowed drug companies to bring therapeutics and vaccines to patients faster. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, we will hear from industry and regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related systems. The Forum presents four tracks: Regulatory Informatics Business, Regulatory Informatics 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.

This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.

Social distancing measures may be in place at the time of the event. Therefore, we encourage you to register and make your housing arrangements early due to potential limited capacity. If the capacity limit is reached, we will only be able to offer the virtual option. Don’t miss out on your chance to meet live again with your friends and colleagues!

Who should attend?

Professionals involved in:

  • Regulatory Affairs and Operations
  • Regulatory Information Management
  • Regulatory Informatics
  • 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 Regulatory Informatics business processes

Program Committee

  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA Senior Vice President, Life Sciences
    Orion Innovation, United States
  • Karen  McCarthy Schau
    Karen McCarthy Schau Director, Global Clinical Operations
    Vertex Pharmaceuticals, United States
  • Peter  Terbeek, MBA
    Peter Terbeek, MBA Senior Director, Publishing and Submission
    Astellas, United States
  • Jake  Doran
    Jake Doran Head of Global R&D IT
    Bausch Health, United States
  • Jo  English
    Jo English Vice President, Regulatory Information Management
    Calyx, United Kingdom
  • Michiel  Stam
    Michiel Stam Head of Data Management and Regulatory Information Scientist
    Qdossier, Netherlands
  • Danielle  Beaulieu, PhD
    Danielle Beaulieu, PhD Senior Director, Global Regulatory Business Capabilities
    Bristol-Myers Squibb, United States
  • Kristen  Sauter, MBA
    Kristen Sauter, MBA Director, Global Regulatory Informatics & Analytics
    Takeda Pharmaceuticals, United States
  • Vahe  Ghahraman, PhD
    Vahe Ghahraman, PhD Senior Director, Global Regulatory Operations Head
    Apellis Pharmaceuticals, Inc. , United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Joanne  Malia, MS, MSc
    Joanne Malia, MS, MSc Director, Clinical Documentation Management
    Regeneron Pharmaceuticals, United States
  • Jamie  O'Keefe
    Jamie O'Keefe Vice President, Business & Technology Consulting
    Just In Time GCP, United States
  • Stacy  Tegan
    Stacy Tegan Senior Program Manager
    Transcelerate Biopharma Inc., United States
  • Divya  Gangaramani
    Divya Gangaramani Regulatory Affairs Associate
    NIH/ Medical Science and Computing, United States
  • Rob  Labriola, MS
    Rob Labriola, MS Sr. Director, Regulatory Operations
    Synchrogenix, United States
  • Sandra A. Krogulski, MA
    Sandra A. Krogulski, MA Associate Director, Submission Management
    Bristol-Myers Squibb Company, United States
  • Demetra  Macheras, MBA
    Demetra Macheras, MBA Director, Regulatory Policy and Intelligence - Regulatory Affairs
    AbbVie, Inc., United States
  • Ethan  Chen, MBA
    Ethan Chen, MBA Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
    FDA, United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States
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