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Bethesda North Marriott Hotel and Conference Center

Feb 03, 2025 7:45 AM - Feb 05, 2025 12:45 PM

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)!

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Highlights & Features

What is happening at Regulatory Submissions, Information, and Document Management Forum


  • Gather insights to hot topics impacting regulatory information in life sciences research and development
  • Hear directly from global regulators on regulatory plans, priorities, and updates to incorporate into your everyday work and processes
  • Identify how advanced technologies and innovation can be applied to impact functions and processes within regulatory affairs

  • Network with like-minded professionals focused on regulatory information in life sciences research and development to discuss best practices and lessons learned
  • Learn how to apply successful use cases, real-world examples, and practical outcomes into your own company or organization
  • Gain insights and discuss how stakeholders are impacted by everyday challenges and how they overcomethese challenges
  • Evaluate future applications of regulatory informatics, trial master file inspection readiness, electronic document management, and electronic regulatory submissions

Four educational tracks:

Track 1: Building and Sustaining Successful RSIDM Foundations

This focus area evaluates and provides insights on how to effectively build and sustain successful regulatory submission, information, and document management foundations within your company or organization. Gain knowledge on how to ensure compliance and stay up to date with the current state of affairs, enabling your business to continuously operate and thrive. The topics covered in this focus area are tailored to accommodate attendees who are either new to the field or seek a comprehensive review of the evolving dynamics and intricacies that shape their day-to-day work.

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Track 2: Optimizing Processes and Procedures

This focus area provides attendees the opportunity to explore what is needed to improve and optimize their organization’s processes, procedures, and data to foster a culture of innovative practices and forward-thinking. Gain knowledge on industry best practices and discover techniques to transcend conventional approaches through problem-solving methodologies and investigation of the impact of new global regulations on your organization's processes and procedures. Tailored to meet the needs of intermediate-level professionals, the topics covered in this focus area provide a valuable platform for attendees seeking to elevate their expertise in the field.

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Track 3: Adopting Innovative Technologies

This cross-cutting focus area provides thought-provoking insights and new perspectives on how to effectively adopt innovative technologies into a company or organization and the systematic approach that is needed to assess the effectiveness and impact of the adopted innovations. This focus area equips attendees with the knowledge and expertise to propel their endeavors even further through the utilization of artificial intelligence, automation, and cutting-edge technologies. Gain first-hand knowledge from global regulatory health authorities on the implementation of new technologies, policies, and guidelines. Geared towards professionals operating at the intermediate to advanced levels of their careers, this focus area nurtures and expands your acumen to achieve pioneering achievements in your field.

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Track 4: Achieving Regulatory Excellence

Developing the ability to achieve regulatory excellence in the life sciences industry necessitates a unique blend of visionary leadership, a culture that embraces transformative change and innovation, strategic decision-making integrated into the company's fabric, an unwavering commitment to continual improvement, and bold actions that challenge conventional norms. This focus area will take a deep dive exploring examples and use cases from companies and organizations that have achieved this successfully while also delving into a wide range of professional and business-related topics. Engage in invigorating panel discussions, absorb invaluable best practices, and acquire tangible and practical implementation strategies to steer your company or organization towards regulatory excellence. This area of focus has been tailored specifically for individuals at an advanced or senior level position within their careers.

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Case Study Spotlights

From concept to execution, each spotlight offers a deep dive into the design process, outlining how we tackle complex challenges and deliver measurable success.

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