Veeva Vault RIM Registration Overview: How Vault RIM Registration works?

This video provides an in-depth exploration of Veeva Vault RIM Registrations, a critical application for pharmaceutical sponsors to manage global product registrations. The speaker, building on previous discussions about the broader Regulatory Information Management (RIM) system, focuses specifically on the registration process, its underlying objects, and key features. The primary purpose is to outline how Vault Registrations enables companies to plan, track, and report on product registrations, manage health authority interactions, and ensure compliance with regulatory requirements.

The presentation delves into the core components of Veeva Vault Registrations, highlighting its function as a single source for global product and regulatory information. It emphasizes the system's ability to manage manufacturing and labeling-related change events, handle activities associated with event responses, and process detailed medical product information such as packaging, dosage forms, and indications. A central theme is the integration of Vault Registrations within the larger Veeva Vault RIM family, sharing a common data model and unique functionalities designed for effective regulatory process management.

A significant portion of the video is dedicated to explaining the "registration object" model, which forms the backbone of the system. This model comprises interconnected objects: Event, Activity, Application, Regulatory Objective, Submission, and Registration. The speaker illustrates the workflow, explaining how a product modification or relabeling (an "event") triggers the creation of associated activities, applications, regulatory objectives, and submissions, often in bulk, for specific countries or markets. The video also details the advanced features of Vault Registrations, including its robust data model built on industry best practices and standards like ISO IDMP and IMDRF UDI, its capability to manage regulatory events, facilitate bulk data creation, and generate a comprehensive history of registration data for audit and compliance purposes.

Key Takeaways:

• Centralized Global Solution: Veeva Vault Registrations serves as a global solution and a single source of truth for managing all product and regulatory information, streamlining the planning, tracking, and reporting of product registrations for pharmaceutical sponsors.
• Structured Object Model: The system operates on an advanced data model comprising interconnected objects: Event, Activity, Application, Regulatory Objective, Submission, and Registration. This structure ensures comprehensive tracking and management of the entire regulatory process.
• Event-Driven Regulatory Management: Regulatory events, such as product modifications, relabeling, manufacturing changes, or regulatory approvals, are central to the system. These events can be classified as global or local (country-specific) and drive the creation of subsequent activities and submissions.
• Compliant Data Output: Vault Registrations is designed to produce compliant product data output, such as xEVMPD and IDMP, which are crucial for adherence to EU regulations, ensuring data integrity and regulatory adherence.
• Industry Standard Adherence: The advanced data model is built upon strong industry best practices and international standards, including ISO IDMP (International Organization for Standardization Identification of Medicinal Products) and IMDRF UDI (International Medical Device Regulators Forum Unique Device Identification), ensuring robust and extensible data tracking.
• Efficient Bulk Data Creation: The system offers bulk data creation functionality, specifically tailored for RIM registration. This allows for the efficient creation of multiple submissions, activities, and regulatory objectives directly from an event page, significantly reducing manual effort.
• Comprehensive Life Cycle Management: Organizations can capture, manage, and track detailed information related to the entire life cycle of products and their associated registrations, providing a holistic view of product status and changes.
• Historical Data Generation for Audits: Users can generate a historical view of registration data, capturing all changes globally throughout the registration record's life cycle. This feature is vital for supporting regulatory requirements and facilitating audit trails.
• Affiliate-Specific User Interface: The platform provides an affiliate-specific user interface, allowing local users to efficiently control and manage events, activities, regulatory objectives, and registrations without navigating through individual objects.
• Application as a Central Folder: The "Application" object acts as a centralized folder within the system, enabling users to track and consolidate all related events, activities, regulatory objectives, submissions, and registrations for a specific product or process.
• Regulatory Objective for Submission Control: The "Regulatory Objective" object is crucial for controlling submissions that need to be sent to health authorities, ensuring that each submission aligns with specific regulatory goals.

Tools/Resources Mentioned:

• Veeva Vault RIM
• Veeva Vault Registrations

Key Concepts:

• Product Registration: The process of officially registering a pharmaceutical product with health authorities in various countries before it can be marketed and sold.
• Health Authority Interaction: Communication and engagement with regulatory bodies (e.g., FDA, EMA) regarding product approvals, changes, and compliance.
• Regulatory Event: A significant change or action related to a product's regulatory status, such as a product modification, manufacturing change, label change, or regulatory approval.
• Global Event: A regulatory event that has implications across multiple countries or regions.
• Local Event: A regulatory event specific to a particular country or market.
• Activity: Specific tasks or actions that need to be performed in response to a regulatory event.
• Application: A centralized folder within Veeva Vault RIM Registrations used to track and consolidate all related regulatory objects for a specific product or process.
• Regulatory Objective: A specific goal or requirement that a submission aims to fulfill, guiding the content and purpose of submissions to health authorities.
• Submission: A package of documents and data submitted to a health authority for approval or notification regarding a product.
• ISO IDMP (Identification of Medicinal Products): A suite of five international standards developed by the International Organization for Standardization to facilitate the unique identification of medicinal products globally.
• IMDRF UDI (International Medical Device Regulators Forum Unique Device Identification): A global system for identifying medical devices, similar in concept to IDMP for medicinal products.
• xEVMPD (Extended EudraVigilance Medicinal Product Dictionary): A European Medicines Agency (EMA) standard for the electronic submission of medicinal product information.
• IDMP (Identification of Medicinal Products): In the context of EU regulations, this refers to the implementation of the ISO IDMP standards for submitting product information to regulatory bodies.