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Bethesda North Marriott Hotel and Conference Center

2025 年 02 月 03 日 7:45 上午 - 2025 年 02 月 05 日 12:45 下午

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Advanced Rates Expire

DAYS

HOURS

MINUTES

SECONDS

概览

February 3-5: Forum

The last few years have 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 people, processes, and technology. Our Forum brings a set of tracks and focus areas, equipping our attendees with invaluable insights on how to build and sustain successful RSIDM foundations, optimize their current processes and procedures, adopt innovative technologies, and achieve regulatory excellence. This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees at all levels.

Participant Testimonials

The forum was incredibly valuable in terms of meeting colleagues from around the world —industry and regulators — and collaborating on solutions to improve submission efficiency andmake data more readily usable. – Virginia Hussong, Chief Data Standards Program, CBER, FDA

Fantastic forum! I am 17 years in the pharmaceutical industry, but new to the regulatory sector, and it was great to align my prior manufacturing knowledge to the regulatory area. Great event! All the right people, all in the right place! – Matthew Tyler, Director of Business Development, Qdossier, a Celegence Company

The breadth of subject matter expertise, and diverse perspectives make RSIDM a must attend event for anyone involved in Regulatory activities. – Gary Colantonio, MS, MBA, Associate Director, Regulatory Affairs, Merck & Co., Inc.

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Highlights & Features

Welcome Video

谁应该参加?

  • Forum Designed For

    • Clinical Data/Data Managers
    • Clinical Operations and Processes
    • Contract Research and Service Support Providers
    • Document and Records Management/Specialists
    • Emerging Pharmaceutical/Biotech/Device Professionals
    • Essential Document Process and Business System Owners
    • Informatics/Bioinformatics Professionals
    • Information Technology and Support Personnel
    • Medical, Technical, and Regulatory Writers
    • Outsourcing/Clinical Outsourcing
    • Quality Assurance/Quality Control and Compliance Professionals
    • Quality Management
    • Regulatory Affairs and Operations
    • Regulatory Informatics
    • Regulatory Information Management
    • Regulatory Standards Implementation Specialists and Associates
    • Strategic Planning and Operations
    • Submissions and Global Submissions Management/Project Management
    • TMF and eTMF Management
    • Vendor Relationship Managers

学习目标

  • At the completion of this conference, the participant should be able to:

    • Recognize key components and define essential practices necessary for building and sustaining effective RSIDM systems that align with current regulatory requirements and global standards
    • Explain methodologies for enhancing operational efficiency within RSIDM processes, and illustrate practical applications of process optimization techniques that foster continuous improvement and regulatory compliance
    • Apply knowledge of emerging technologies, including AI and automation, to regulatory information management challenges, and demonstrate how these innovations can enhance data quality and submission efficiency
    • Analyze the impact of global standards, such as eCTD and IDMP, on regulatory submissions, and differentiate between regional regulatory requirements to effectively navigate international compliance challenges
    • Synthesize insights from case studies and expert discussions to create actionable strategies for achieving regulatory excellence within an organization, emphasizing leadership, decision-making, and process transformation
    • Evaluate the importance of cross-functional collaboration in regulatory affairs, and appraise approaches to fostering interdepartmental communication, aligning regulatory submissions with organizational goals, and enhancing overall submission success

项目委员会

  • Jillian E. Carinci, MS
    Jillian E. Carinci, MS Senior Director, Head of Submission Sciences
    Biogen, United States
  • Cary  Smithson, MBA
    Cary Smithson, MBA Managing Partner
    LeapAhead Solutions, Inc., United States
  • Sandra  Krogulski, MA
    Sandra Krogulski, MA Director, GRSO Innovation and Business Operations Lead
    Bristol-Myers Squibb Company, United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States
  • Rita  Algorri, PhD, MS
    Rita Algorri, PhD, MS Senior Manager, Global Regulatory Affairs (CMC)
    Amgen, United States
  • Jennifer  Dames
    Jennifer Dames Director, RA Submission Management
    AbbVie, United States
  • Lindsay  Fitzgerald
    Lindsay Fitzgerald Delivery Manager
    Astrix Inc., United States
  • Dominik  Gigli
    Dominik Gigli Management Consultant & Regulatory Consulting Lead
    Main5 GmbH & Co. KGaA, Germany
  • Shenqi (Handsome)  Ji
    Shenqi (Handsome) Ji Regional Publishing Lead, Asia, Global Regulatory Operations
    Pfizer, China
  • Jared  Lantzy, PMP
    Jared Lantzy, PMP Executive Director, Global Regulatory Operations
    Novavax, Inc., United States
  • Kunal  Lal, MBA
    Kunal Lal, MBA Consultant - Strategy & Change
    Red Nucleus, United Kingdom
  • Aliza  Nathoo
    Aliza Nathoo Senior Director, Content Strategy
    F. Hoffmann-La Roche Ltd., Canada
  • Daniel  Offringa
    Daniel Offringa Principal Consultant
    eSub Solutions, United States
  • Nimesh  Patel
    Nimesh Patel Director of Global Regulatory Systems
    Eisai Pharmaceuticals, United States
  • Vladimir  Penkrat, MBA
    Vladimir Penkrat, MBA Head of Regulatory Affairs
    Indegene, United States
  • Noelia  Plaza
    Noelia Plaza Director of Process Excellence & Analytics
    Daiichi Sankyo, United States
  • Theresa  Pinnell, MLS
    Theresa Pinnell, MLS Director of Regulatory Solutions
    Kivo, United States
  • Maria Johnette Barhams Sagoua, MHA
    Maria Johnette Barhams Sagoua, MHA Director of Regulatory Innovation
    Accumulus Synergy, United States
  • Seyoum  Senay, MS
    Seyoum Senay, MS Supervisory Operations Research Analyst, CDER/OBI
    FDA, United States
  • Matthias  Sijtstra
    Matthias Sijtstra Senior Consultant
    Main5 GmbH & Co. KGaA, Netherlands
  • Representative Invited
    Representative Invited DIA, United States

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