Health Authority Correspondence with CARA

This video demonstrates a specialized workflow for efficiently managing, translating, and retrieving information related to Health Authority (HA) correspondence using the CARA Life Sciences Platform. The primary objective is to streamline the process of handling questions received from regulatory bodies across different countries and languages, ensuring that companies can quickly generate consistent, multilingual responses and establish a robust, searchable knowledge base. The demonstration begins by showcasing the import of a document containing multiple HA questions, emphasizing that the system can handle various templates and leverage character recognition technology to process the input.

Upon import, the CARA platform automatically dissects the source document, extracting each individual question into a separate, structured "question object" record. This structured approach is crucial for triggering automated workflows, setting up notifications for relevant personnel, and ensuring proper tracking. The system allows for the automatic population of metadata fields essential for regulatory tracking, such as the ECTD (Electronic Common Technical Document) section, receipt date, and email subject, minimizing manual data entry. The core functionality highlighted is the multilingual capability: once a question is captured, the system automatically translates it into specified target languages (demonstrated examples include Japanese, English, Korean, and Chinese).

The true value proposition lies in the answer generation and knowledge management features. When a user inputs the definitive answer into the designated field, the system instantly translates that answer into all associated target languages, ensuring consistency across global regulatory submissions and communications. Furthermore, the platform maintains a direct link to the original source document for reference and can automatically generate the final answered document. Most importantly, this structured data—the question, the answer, and associated supporting documents—is made fully searchable across all translated languages. This capability allows global teams to quickly find previously approved answers to similar HA inquiries, regardless of the language or country of origin, significantly reducing response times and mitigating regulatory risk associated with inconsistent information.

Key Takeaways: • Structured Management of Regulatory Inquiries: The platform emphasizes the necessity of converting unstructured correspondence (like emails or documents) into structured data objects, treating each Health Authority question as a distinct record to facilitate tracking, workflow automation, and auditability. • Automated Multilingual Translation: A critical feature is the automatic translation of both the incoming HA questions and the definitive company answers into multiple target languages (e.g., Japanese, Korean, Chinese), ensuring global consistency in regulatory responses without requiring manual translation efforts for every communication. • Enhanced Knowledge Retrieval: By structuring and translating the Q&A pairs, the system creates a powerful, searchable knowledge base. This allows regulatory and medical affairs teams to search for existing answers using keywords in any supported language, drastically speeding up response times for recurring or similar regulatory questions. • Workflow Triggering and Notification: The import of a new HA question object can automatically trigger predefined workflows and notifications, ensuring that the appropriate subject matter experts (SMEs) are immediately alerted and assigned tasks to formulate the official response. • Regulatory Metadata Capture: The system supports the automatic population of key regulatory metadata, such as the relevant ECTD section and receipt dates, which is essential for maintaining compliance and preparing for future regulatory submissions and audits. • Mitigating Inconsistency Risk: The centralized input and automatic translation of the official answer prevent the risk of different regional affiliates providing slightly varied or inconsistent responses to the same regulatory question, a common compliance pitfall in global operations. • Leveraging Character Recognition: The platform can utilize character recognition technology (OCR) to extract text and structure from various document templates, improving the efficiency of importing correspondence that may not arrive in a standardized digital format. • Direct Document Reference: The system maintains a direct link between the structured question object and the original source document received from the Health Authority, providing immediate context and reference for users formulating the response. • Automated Answer Document Generation: The platform is capable of automatically generating the final, formatted answered document based on the structured data input, streamlining the final submission process.

Tools/Resources Mentioned:

• CARA Life Sciences Platform (by Generis)

Key Concepts:

• Health Authority Correspondence: Formal communications, typically questions or requests for clarification, received from regulatory bodies (like the FDA or EMA) regarding submitted applications, clinical trials, or marketed products.
• ECTD (Electronic Common Technical Document) Section: A standardized structure for organizing regulatory submission documents globally, ensuring that all relevant information is categorized correctly for review by health authorities.
• Question Object: A structured data record within the CARA platform that represents a single question received from a Health Authority, used for tracking, workflow management, and knowledge indexing.