亮点与特色

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

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Track Alignment for 2026!

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.

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. The topics covered in this focus area provide a valuable platform for attendees seeking to elevate their expertise in the field.

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. This focus area nurtures and expands your acumen to achieve pioneering achievements in your field.

Track 4: Strategic Leadership and Organizational Readiness

This focus area explores the critical organizational, leadership, and strategic factors that drive successful regulatory transformation and prepare companies for future demands. This track dives into how leadership, governance, and forward-thinking planning contribute to building future-ready regulatory capabilities. Topics in this track move beyond foundational execution and technological optimization to examine broader structural and strategic enablers of regulatory excellence. Sessions will highlight case studies and success stories from companies that have effectively aligned regulatory strategy with enterprise vision, fostered cultures of innovation, and implemented agile governance and continuous improvement frameworks.

International Regulatory Collaboration through ICH and Latest Developments for Regulatory Affairs

Complimentary Content Preview Webinar!
October 15, 2025 | 11:00AM ET – 12:15PM ET

The International Council for Harmonization (ICH) was established to bring together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registrations, aiming to ensure safe, effective, and high-quality medicines. This webinar aims to provide an overview of ICH and share recent developments in ICH Guidelines including advancements in M11 for clinical trial protocols and updates to M4Q(R2) for quality documentation. The session will conclude with a Q&A segment, providing an opportunity for attendees to engage with experts from regulators and industry.

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