RIMS – Better Manage Your Regulatory Information
With the transition across Europe to the IDMP altering the way that information is globally exchanged, it is becoming increasingly important to have a RIMS in place to harmonise submissions and to help you better manage your data. ProductLife Group (PLG) can provide you with the knowledge and expertise to help you navigate these changes.
What is RIMS?
A Regulatory Information Management System (RIMS) streamlines the process of submitting human and veterinary medicinal products to regulatory agencies when obtaining marketing authorisation. It is a practical software system that supports the management of product dossiers and regulatory information, the preparation of product submissions and the management of regulatory product information in the approved formats.
Although most life sciences companies have a RIMS in place, many continue to use manual data entry. In today’s environment, RIMS should be ready to send data directly to the EMA and companies will need to collect more data, earlier in the process, with robust technology.
What is IDMP?
In June 2021, the European Medicines Agency (EMA) published guidance on the International Organisation for Standardisation (ISO) Identification of Medicinal Products (IDMP). The IDMP will cover the 5 ISO standards, providing standardised descriptions to identify and describe Implementing Regulation (EU) No 520/2012, and the use of the ISO IDMP will be required for the exchange and communication of information on medicinal products from the autumn of 2022. The standards will be implemented using the Substance, Product, Organisation and Referential (SPOR) programme, which will cover the four areas of master data to facilitate the consistent and robust exchange of information.
The IDMP will have a widespread impact on the planning and preparation of submissions as well as the management of data through a medicinal product’s lifecycle. This will bring many benefits, transforming the way that data is exchanged and managed globally, improving regulatory efficiency, pharmacovigilance, and patient access to healthcare information and medicines. With greater data harmonisation and transparency, it will facilitate and enhance the exchange of medicinal product information among regulators.
With the updated regulation for IDMP expected in October 2022 and implementation by April 2023, are you prepared for the upcoming changes?
RIMS can help you to navigate the IDMP:
The data and information that life science companies produce and share are often distributed across organisations in many different formats. Bringing centralised RIMS data into the IDMP system is a good start, but locating, extracting and sharing data buried in documents across an organisation can be a daunting task. In an IDMP data-driven world, it will become increasingly important to incorporate technological solutions to align and streamline centralised and non-centralised procedures in your organisation.
At ProductLife Group (PLG), our experts can help you to enhance your processes and prepare for the IDMP:
IDMP compliance transforms the way medicinal product data is managed across the entire lifecycle process, which can bring many cross-functional challenges to life science companies.
To reach IDMP/SPOR readiness, it is important to understand where the relevant data is sourced from. A gap analysis can be useful in providing a solid understanding of the current state to help highlight any gaps that must be solved to reach compliance. To enhance your current processes, PLG can assess data quality by performing quality checks and gap analyses to compare multiple sources of information either internally (RIMS, regulated documents) or externally (Extended EudraVigilance Medicinal Product Dictionary), which will help determine ways to improve and better monitor data quality.
PLG can support you in the implementation of IDMP/SPOR by defining a single source of truth within a company, learning about the company’s data ownership management, and by building a master-data-management approach. This may include enhancing interfaces between RIMS and other systems by designing and implementing a RIMS and other systems in manufacturing, supply, or drug safety.
PLG can also help you effectively manage your regulatory information and enhance system processes via electronic-document-management/regulatory-information-management (EDM/RIM) data entry. PLG can improve your document uploads and reduce data backlog by conducting regular data entry and acquiring a thorough collection of documents and data from affiliates and local agents. This includes xEVMPD data entry to the EudraVigilance Web interface (EVWEB) or through a RIMS. PLG supports business administration and data integrity for client systems by managing data stewardship in SPOR, acting on behalf of clients or in support of clients to manage SPOR master data internally.
Why choose PLG?
At PLG, our dedicated teams have the knowledge and expertise to define the best compliance strategy and to bring cross-functional interactions within companies to further harmonise the process.
Our experts combine their experience with the tools used in regulatory operations, knowledge of the health authorities’ requirements and a broad understanding of business processes to help clients achieve compliance with the IDMP and to help them more effectively manage their regulatory information.
With many long-standing relationships with vendors in the industry, PLG provides the best solutions that are always tailored toward a client’s specific needs.
With PLG’s support, clients can bridge the gaps between a company’s regulatory, business and information technology units to produce a harmonised workflow to enhance processes to bring in positive change.
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