Mastering Controlled Vocabularies with BASE Regulatory QC Plug-In

Naming standards as foundation for efficient information exchange…

Collaboration and information exchange are one of the main goals behind many Regulatory Information Management (RIM) System implementations within Life sciences organizations. Collaboration is continuing to be at the center of many technology and process initiatives, it is driven by an increased information and data exchange internally and externally with regulators and Health Authorities (HAs). This general need to effectively exchange information and data forced HAs to implement industry standards, e.g. xEVMPD and IDMP. With these standards, companies have significant work to get common terminology and naming standards.

In the industry we found many ways of identifying these standards: naming standards, naming convention, preferred terms, Controlled vocabularies (CVs)…etc. Whatever we can call them, these standards have one common purpose:

BASE Approach to CVs

Setting controlled vocabularies within an organization and for a RIM system could face many challenges, among them: alignment with the HAs standards, different used terms within a global organization, different terms used to depend on regions and / or local requirements and the difference between sources of information / data.

Health Authorities guidance…becoming legal requirement

For standardization to succeed an alignment with HAs standards is key. Therefore to support the industry the regulators cleared the way by owning initiatives like xEVMPD and future IDMP (ISO IDMP standards) and providing many sources of guidance and information: e.g. MedDra (developed by ICH working group in 90’s to facilitate the identification of common data sets for evaluation of clinical and safety information), EDQM standards terms to define certain key elements of a medicinal product (pharmaceutical dose form, route of administration and packaging items…etc.)

From 2012, submission of data on medicines is a legal requirement introduced in Article 57(2) of Regulation (EC) 726/2004. The intended use of common terminologies and format to uniquely identify and exchange information on medicines is as follows:

· reduce costs by decreasing the duplication of encoding and maintenance of the same information on medicines,

· contribute to the establishment of interoperable systems for the exchange of information on medicines reducing the operational risks due to lack of common dictionary and terminology on medicine’s information

· strengthen the communication between companies’ database and the EU regulatory systems speeding up decisions and actions.

Internal alignment is a must

Following HAs guidance in term of terminology standardization is not enough, an alignment internally with different stakeholders to agree on the naming convention is important as vocabularies challenge could be multiple: Regulatory people do not have the same expectation and are not using the same terms as the pharmacovigilance or clinical colleagues. The companies source systems contain same information but not in the same format, e.g. packaging details in ERP system would not be described at the same format as in RIM system. A description of a pharmaceutical form could be different if We are based in UK or in US (e.g. prolonged release tablet vs. extended release tablet), active substance or ingredient could be named differently depending on the sources (e.g. paracetamol vs. acetaminophen)

Agreeing on CVs could not be done without involving people, aligning processes and using technology to leverage data enrichment, cleaning and Quality Check (QC).

Migration and BASE Regulatory QC Plug-In

In one of our BASE Whitepaper, We addressed the migration challenges and one of main recurrent issue that an organization could face during a migration project is the data consistency and data quality.

Migrating content not only involves moving documents or data from one source to another one, a successful migration project consists also on ensuring a consistent data quality responding efficiently to regulators requirements and internal business processes. Including a QC step in the migration framework is the best option to tackle the terminologies and Controlled vocabularies concern during a migration project.

In this context, and always looking to better respond to our clients’ needs, BASE developed in-house an automated Regulatory QC Plug-In to be added to our migration framework. This QC Plug-In is able to:

· highlight the areas of improvement with respect to regulatory compliance (e.g. xEVMPD, MedDRA, SPOR…etc.)

· compare data in the source system with the regulatory standards (e.g. CVs and naming conventions)

· flag areas of potential non-compliance as input to the data cleansing

Consistently improving our migration approach

We continuously improve our own BASE Migration framework to efficiently respond to the industry standards, regulatory changes and business needs, BASE Regulatory QC Plug-In is the perfect example enabling a fast quality check and data cleaning ensuring a smoother migration process.

About BASE life science

BASE life science is a fast growing, fast paced consultancy focused on the life science industry. Established in 2007 and based in Copenhagen, Denmark, BASE targets a local as well as a global customer base.

Since inception, BASE life science focuses on helping Life Science companies create real business value from digital platforms and data within its area of expertise, Commercial Excellence, Clinical, Regulatory Affairs and Quality & Compliance. Since 2007, the company has been active globally from Denmark and Switzerland with more than 60 employees.

About the author — Badr Fathi, PharmD, Senior Principal Regulatory Lead

Customer-centric consultant focused on solving regulatory processes and IT systems challenges for pharmaceutical companies through advisory, assessment or implementation services. As Regulatory SME and Project Manager, Badr has a strong expertise in business processes and an extensive experience with various Regulatory and Clinical projects. Badr has 15 years’ experience within Regulatory and clinical areas.

Phone: +41 76 439 26 29, email: bafa@baselifescience.com

BASE life science is a fast growing, fast paced consultancy focused on the life science industry.

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