Regulatory Vault Overview

This video provides an in-depth overview of Veeva Regulatory Vault, a specialized application designed to manage the complex process of drug approval and submission to regulatory authorities post-clinical trial operations. The speaker elucidates the critical steps involved in bringing a drug to market, emphasizing how Veeva Vault facilitates the entire regulatory lifecycle from initial data creation to final submission archival. The core purpose of the vault is to ensure that pharmaceutical products meet the stringent requirements of various national and international regulators, such as the FDA in the US, before they can be sold in respective markets.

The presentation details the structured workflow within the Regulatory Vault, beginning with the creation of foundational master data. This includes defining product families (e.g., paracetamol), specific product names (company brand), and product variants (e.g., 150mg, 300mg, 100ml). Beyond product details, master data also encompasses information about manufacturers and packaging. Once this essential data is established, the process moves to creating transactional objects like "applications," which are market-specific (e.g., one for the US, one for Canada) for the same drug. Under each application, multiple "registrations" are created for different product variants. Further granularity is achieved through "events" and "regulatory objectives," which define the specific purpose of a regulatory action, such as seeking initial approval or making a manufacturing name change.

The culmination of this process is the "submission," where all necessary documentation is prepared for regulatory authorities. The video highlights the importance of a "content plan," which structures the submission according to established formats like the electronic Common Technical Document (eCTD). This plan consolidates clinical trial data, regulatory documents, and other relevant information into a coherent package. Once submitted, the regulatory authorities review the content, often raising "health authority questions" that require responses from the publisher. Upon satisfactory resolution and review, the submission receives approval, allowing the drug to be marketed. Veeva Vault offers extensive customization features to streamline these steps, including options for creating objects, managing complex data relationships (object joins), structuring content plans, publishing, and archiving, all within a unified and easily navigable interface.

Key Takeaways:

• Veeva Regulatory Vault's Core Function: The vault is designed to manage and streamline the entire regulatory process for pharmaceutical products, from post-clinical trial operations to market approval, ensuring compliance with global regulatory bodies like the FDA.
• Comprehensive Regulatory Lifecycle: The system supports a multi-stage regulatory journey, encompassing registration, submission preparation, publishing, and final archival of all related documentation.
• Foundational Master Data Management: The process begins with meticulously creating master data for product families, specific products, various dosage forms or variants (e.g., 150mg, 300mg), manufacturers, and packaging details, which forms the bedrock for all subsequent regulatory activities.
• Market-Specific Applications: Regulatory submissions are organized through "applications" tailored for each target market (e.g., separate applications for the US and Canada), reflecting the unique requirements of different regulatory jurisdictions.
• Granular Product Registration: Within each market application, "registrations" are created for specific product variants, allowing for precise tracking and management of different formulations or strengths of a single drug.
• Defining Regulatory Objectives: Each regulatory activity is associated with a clear "regulatory objective," which specifies the purpose of the action, such as initial market approval, a change in naming convention, or an update to manufacturing details.
• Structured Submission Content Plans: A critical component is the "content plan," which dictates the structure and organization of submission documents, often adhering to industry standards like the electronic Common Technical Document (eCTD) for efficient review by authorities.
• Interactive Health Authority Engagement: The vault facilitates the management of interactions with regulatory bodies, including tracking "health authority questions" and organizing responses from the publisher until final approval is granted.
• Veeva Vault's Customization Capabilities: The platform offers robust customization features for creating various objects, defining complex relationships through "object joins" (one-to-one, one-to-many, parent-child), and automating actions like content plan structuring, publishing, and archiving.
• Centralized Document Management: All regulatory documents, from clinical trial approvals to final submission packages, are consolidated and managed within the vault, ensuring a single source of truth and easy access in a structured manner.
• Enhanced Compliance and Auditability: By providing a structured and auditable framework for managing regulatory submissions, Veeva Vault helps pharmaceutical companies maintain compliance with stringent industry regulations and streamline audit trails.
• Self-Learning Resources: For deeper understanding, users are encouraged to explore the Veeva Vault Help page, specifically focusing on the registration, submission, and submission publishing sections.

Tools/Resources Mentioned:

• Veeva Regulatory Vault
• Veeva Vault Help page

Key Concepts:

• Regulatory Vault: A specialized application within the Veeva ecosystem designed for managing regulatory submissions and compliance in the pharmaceutical and life sciences industries.
• Master Data: Core, foundational data about products (family, name, variant), manufacturers, and packaging that underpins all regulatory activities.
• Application (Regulatory): A transactional object created for a specific drug in a particular market (e.g., US, Canada) to manage its regulatory journey.
• Registration (Regulatory): A record created under an application for a specific product variant, detailing its regulatory status and submission history.
• Regulatory Objective: The defined purpose or goal of a specific regulatory activity, such as seeking new drug approval or making a post-approval change.
• Submission: The complete package of documents and data submitted to a regulatory authority for review and approval.
• Content Plan: A structured outline that dictates the organization and content of a regulatory submission, often following industry standards like eCTD.
• eCTD (Electronic Common Technical Document): A globally accepted standard for organizing regulatory submissions for new drug applications, providing a common structure for all regions.
• Health Authority Questions: Queries or requests for additional information raised by regulatory bodies during their review of a submission.
• Object Joins: Features within Veeva Vault that define relationships between different data objects (e.g., one-to-one, one-to-many, parent-child), ensuring data integrity and navigability.