Maintaining and improving data management activities in regulatory operations adhering to timelines, budget and defined processes
Quality data needs to be recorded for various strategic activities starting from drug development, to market introduction, to lifecycle management along with post marketing. Pharma companies require a Regulatory Information Management System (RIMS) for collecting and storing regulatory information during the lifecycle of a product. In addition, a RIMS is required for product data collection, product registration tracking, product submission enablers, easy and efficient publishing, safety related data, document management and data used for planning and analysis for strategic requirement.
Wipro’s consulting and operations for regulatory information management cater to small- and large-scale implementations and transformation projects along with the technology implementation. Wipro’s deep knowledge of operations and technological requirements makes us unique in the market, helping companies drive improvement and standardization in data, while creating IT interfaces to mitigate any technological challenges.
RIM at Wipro
- Streamlining of regulatory processes to ensure the organization’s compliance
- Product portfolio and related data management services
- Data mapping, data collection, and data profiling along with data remediation activities for enriching data points
- Data governance model – Efficiently manage data as business asset and provide day-to-day direction and oversight
- Submission and planning management
- Regulatory intelligence and information management
- RIM related technology consultancy and implementation
Identification of Medicinal Product (IDMP) is the current and most challenging requirement for pharma companies and the industry that will impact people, processes and technology. In the quest for one source of truth, IDMP implementation will be the change agent for medicinal product businesses and will help in developing harmonized data. IDMP has created an immediate opportunity in RIM and how we manage regulatory data. This is a continuous process of making business compliant, right from structuring data, making business process better and submissions easier. However, this will need significant changes in how the business is viewed till now. It requires integration of internal and external systems, collection of data and making it compliant as per ISO IDMP data structure / SPOR structure, formats and medical dictionary.
With the release of the EU IDMP implementation guide v2.0, the two year countdown to compliance requirements has already begun and all new submissions in future will be done through the IDMP format. Initially implemented by EMA, it will be adopted by all regulatory bodies in future.
Wipro acts as the ideal IT vendor with specialized resources required for perfect implementation and ensuring proper governance of IDMP transformation. Wipro is well versed with the five ISO IDMP standards and corresponding technical specifications as well as EU IG V1.0, 2.0 & 2.1 guidance documents for substance, product, organisation and referential (SPOR) data implementation. Through seamless IDMP process execution, a pharma company can avail several benefits such as quality data, improved processes, integrated ways of working between various functions, and enhanced transparency.
IDMP at Wipro
- Identification of Medicinal Product (IDMP) approach and strategy creation
- Discovery based value study on current regulatory information management and XEVMPD
- A gap-analysis based on the data points available and remediation plan on how to collect 15 times more data required compared to xEVMPD
- Collection of data as required under five IDMP ISO standards. E.g., Mining of SmPC and Module 3 documents as part of data collection
- Harmonizing data across all functions of a company
- Collection, reporting and submission of IDMP data as per prescribed formats
- Technology changes in existing RIMS as per IDMP standards