Manage the complex task of registration tracking, planning and reporting
Registration tracking, planning and reporting on clinical trial authorization applications and marketing authorization applications is a complex task due to the many variables across products and countries.
The variables include descriptions and identifiers of registered products, substances, pharmaceutical products, packaged components and manufactured items to describe the content of products. It also includes the context of products such as, by whom is it registered where and since when; who approved it and who manufactured it. All of this type of information (and more) is to be registered to allow for attributing adverse events to the registered product, the pharmaceutical product, a packaged component, a drug substance or a manufacturer. With this, signal detection is to be improved and corrective actions can be made to reduce hospitalization and deaths due changes in any of those variables.
Lack of authoritative data sources and common terminology
Too often companies have multiple sources with various terminology for the same information. As a result, employees cannot (fully) rely on the information in their Regulatory Information Management (RIM) system. It is obvious that the true data is somewhere, but lack of trust makes people set up their own spreadsheets/databases which need to be verified any time a question is raised.
Regulators face the same problems about multiple sources and various terminology. Therefore, the EU regulators implemented an new structure called XEVMPD and initiated the development of ISO IDMP (a further extension of XEVMPD-like data and data types). Both, the EU-EMA and US-FDA have been developing standardized terminology to be used in the XEVMPD structure (EU only) or IDMP structure. Industry could, or better should, take advantage of these initiatives to manage unambiguous authoritative data sources within their own organizations, irrespective of a deadline for submitting this data as such to the health authorities.
Our specialists understand the business needs; know what structures have been developed; what controlled terminology can be used and how software tools need to be configured to facilitate the Product registration tracking, planning and reporting. Our specialists have experience with different regulatory tracking systems (incl. ArisGlobal Register, Samarind RMS and Lorenz drugTrack) and have a thorough understanding of the business context. We help companies to establish a strong and reliable RIM solution, which can be used as a transparent source of truth across regulatory affairs and beyond. This includes efficient registration planning, tracking and reporting and timely management of health authority correspondence and commitments.
Our consultants can help you to streamline end-to-end regulatory information management with optimized daily business workflows. We understand the importance of data governance, minimizing data duplication, real-time availability of data and flexible reporting. Our consultants help you to implement the right combination of technical and procedural measures to achieve this and be able to support different regulatory use cases. This includes use cases which extend beyond the Regulatory Affairs department like Change Control, Safety Reporting, XEVMPD and Serialization (Track and Trace).
Our data stewards can help to manage your structured product data and maintain, restructure or cleanse the data in your registration tracking database. This includes structuring of substance information (ingredients), packaged medicinal product information, details related to indications and contra-indications and submission of authorized product information in XEVMPD.