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Bethesda North Marriott Hotel and Conference Center

2025 年 02 月 03 日 7:00 上午 - 2025 年 02 月 05 日 3:00 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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)!

Early Bird in affect

DAYS

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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.

While we develop our 2025 Agenda, please take a moment to review our 2024 FINAL PROGRAM!

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

谁应该参加?

  • Meeting 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

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