Leading up to her participation in “Are You Prepared for IDMP? – A Virtual Panel,” Director of RIM Business Consulting, Karen Harry, explains her role on the IDMP SPOR Task Force and how IDMP will transform the way data is managed in the pharmaceutical industry.
What is your role on the IDMP SPOR Task Force?
Being a member of the SPOR Task Force provides the opportunity to work with IDMP SMEs across the industry and to provide feedback to the EMA. We meet regularly to review the draft EU implementation guides and provide feedback and comments for consideration by the EMA.
Being part of the Task Force also includes representation on other industry- and vendor-related forums (including the Inter-association Working Group & PMS Subgroup). Because I work closely with several of our clients for their IDMP needs, my position within the task force will reflect the discussions and needs that they have for a technology solution.
“IDMP, along with several other initiatives such as UNICOM, will transform the way data is managed in the pharmaceutical industry.”
– Karen Harry, Director of RIM, Calyx
What impact do you think IDMP will have on the industry?
With the EU taking the lead and other countries following in their path, XEVMPD has paved the way for the Industry; establishing processes and resources to maintain the data set. There will be challenges not least of which will be the parallel submissions for XEVMPD and IDMP, as well as managing the data enrichment and understanding concepts such as Pharmaceutical Product, Manufactured Item, and Packaged Medicinal Product.
Ultimately, however, standardizing product data will result in positive outcomes; aligning IDMP submissions with the submission of the dossier, supporting cross border e-prescriptions, and delivering significant efficiencies in support of pharmacovigilance activities.
You’re currently leading the Calyx RIM Business Consulting team, what is their role?
Calyx’s RIM Business Consulting team is made up of a fantastic group of Regulatory Subject Matter Experts (SMEs) who support our clients by providing best practice recommendations. They are instrumental in helping clients understand the impacts of the changes for their business processes, configuration, and user documentation. They also provide guidance in the use of new and existing functionality and analysis for any data remediation or migration efforts.
We have SMEs across Calyx RIM for Publishing and Registrations; most have previously worked in the industry and all understand the scope of the deliverables, priorities, and tight timelines that our clients’ project teams face during the implementation of a new system and with maintaining that user buy-in going forward.
What can we expect from Calyx RIM for IDMP over the coming months?
At Calyx, we’ve been making great progress defining business & system requirements for IDMP Iteration 1. Working with Product Management, our IDMP SMEs have been scrutinizing the EU implementation guides to create in-depth requirements to update the data model to support new concepts and attributes that are introduced. This review also informs our business process best practices. Our business consulting team is leading workshops to support IDMP education, data readiness, remediation, and migration.