Daniel Isaac Kemajou Njamen

Daniel Isaac Kemajou Njamen

Dynamic and passion-driven software consultant with hands-on experience in AI-driven data management solutions, and cloud computing architectures.

IDMP Gap Analysis Tool

Description:

As a Software Consultant at Pharma IT💼, I designed and developed the IDMP Gap Analysis Tool🔍, a progressive web application 📱 aimed at providing a GxP-compliant solution for the pharmaceutical industry. The application facilitates the management and submission of medicinal product data in compliance with the Identification of Medicinal Products (IDMP) standards set by the European Medicines Agency.

Key Features and Responsibilities:

  • Data Ingestion and Processing Pipelines🔄:
    • Implemented functionality for users to create studies either by uploading files (such as PDFs and XMLs) or by conducting searches through public health authority databases.
    • Developed AWS Lambda functions to handle backend processes, including the creation of studies, uploading files to Amazon S3 buckets, and triggering subsequent data extraction events.
  • Integration with Cloud Services and AI Models☁️🤖:
    • Leveraged AWS services such as Lambda, S3, DynamoDB, Amazon RDS (PostgreSQL) and Bedrock to create a serverless architecture that is scalable and cost-effective.
    • Integrated Claude 3.5 Sonnet via AWS Bedrock for advanced data extraction from unstructured documents.
    • Performed data preprocessing tasks, including PDF to text conversion and Optical Character Recognition (OCR) for scanned documents🖨️, to prepare data for the LLM.
  • Data Extraction and Metadata Management🗂️:
    • Extracted key data fields from regulatory documents(SmPC, Module 3 …) and populated the IDMP minimal configuration metadata in DynamoDB.
    • Managed metadata and processing states within DynamoDB to track the progress of data extraction and ensure data integrity✅.
  • Frontend and Backend Integration🖥️:
    • Developed the frontend using Vue.js, creating a responsive and intuitive user interface.
    • Implemented real-time updates and state management to reflect backend processing, using periodic checks to synchronize data between the frontend and backend services.
  • Data Matching and Validation✔️:
    • Enabled users to compare extracted data against authoritative sources such as the European Medicines Agency’s SPOR data.
    • Facilitated the identification of data gaps and discrepancies to ensure regulatory compliance.
  • Regulatory Compliance and Data Security🔐:
    • Ensured GxP compliance, focusing on data integrity, security, and adherence to industry regulations.
    • Secured data access with AWS IAM roles and policies.

Key Areas of Project Development:

This project provided practical insights into open data management and metadata management🗂️ in cloud-based environments☁️.