Regulatory teams serve as a gateway between life science organizations, the health authorities, and the market. In the past several years, great strides have been made to make regulatory teams smarter and more efficient. The journey to IDMP is something that aligns with this perfectly. IDMP stands for Identification of Medicinal Products and serves to standardize product information and facilitate the exchange of data between pharmaceutical companies and global regulators with the goal of improving patient safety. The IDMP standards call for all pharmaceutical and biotechnology firms to submit detailed product information for products marketed in Europe and to maintain it on an ongoing basis.
ArisGlobal’s vision for IDMP was to provide a solution that can adapt over time to support our client’s journey through continued xEVMPD compliance, multiple phases of IDMP compliance, and beyond. The scope is not just in Europe but also adoption of ISO IDMP standards by other regions. It keeps an organization completely insulated from the changing regulations and timelines, increasing their compliance agility, and minimizing your technology and expenditure risks.
“ArisGlobal is well positioned to help companies of all sizes master high quality data sets as a basis for process automation,” said,Pratyusha Pallavi, Senior Director, Regulatory at ArisGlobal. “We are able to offer substantial efficiency gains and risk reduction benefits by addressing IDMP requirements through our core LifeSphere Regulatory platform,” she added.
Our current LifeSphere® Regulatory solution can already be utilized to start the IDMP journey, by initiating your data capture process. This can be achieved through our current ESB Integration module to collect data from various sources, automatically combine them with product registration data present in Regulatory Data modules, take them through the requisite review and approval process to generate required IDMP records with validated business rules.
The Regulatory Data modules hold approved product information in an ISO-IDMPand xEVMPD compliant model including EU extensions. This data model is normalized considering that that many sub-concepts of the IDMP Medicinal Product are common and hence centrally managed. This enables the ‘review once, use often’ principle for common data elements including organizations, substances, CVs, pharmaceutical products, clinical particulars, and others, across different medicinal products. Cross-departmental business process efficiency and collaboration are improved. ArisGlobal is committed to continually providing an updated data model in line with evolving and newer data regulations from EU and other regions.
Through the Integration Module, extracted data is transformed and mapped to LifeSphere® IDMP’s product data hub model by using configurable web service APIs of the application. Once the data is collated, our proven compliance module manages the creation of records for the various regulatory compliance submission standards i.e. xEVMPD, IDMP, UDI, SPL, and others. This approach to extracting data from a central regulatory data hub supports central data management and simplifies the data
management process. This allows our clients to publish data in multiple formats, whether it be to meet IDMP standards or other global regulations.
ArisGlobal’s product scope prioritization and release planning process, actively monitors all regulatory changes, including changes in standards. With our policy of two major releases per year on our regulated pre-validated cloud environment, we ensure our customers remain compliant with IDMP and other standards.
The application also supports company internal vocabulary as well as partner vocabulary lists. Company vocabulary is used to manage data entry and is mapped with partner vocabulary. This mapping is used to generate messages with the required partner values for the respective partners. The application has integration with EMAs, RMS, and OMS built in as well. All departments within an organization need to submit data that shares a common language and structure and our IDMP dictionary allows terminology to remain aligned.
IDMP data standards are forcing companies to capture more data than ever before and have created lasting change for the industry after years of development. Effective data management can be time consuming and costly. ArisGlobal has simplified RIMS and IDMP processes that ensure compliance while transitioning to the new standard. ArisGlobal’s regulatory suite of products accelerates time to market for important compliance initiatives including IDMP.
To learn more about ArisGlobal’s IDMP: LifeSphere IDMP – ISO IDMP Software Solution | ArisGlobal | ArisGlobal