Product Lifecycle Management Insights will provide you:

• Quarterly updates in your inbox with the most important news and announcements.
• Reminders of actions and opportunities related to PLM tools and systems.
• Links through to more details and useful resources to support you in your preparation and adoption of new tools and systems.

PLM is one of three value streams in EMA’s Network Portfolio covering the digital capabilities to support the product lifecycle implemented by the Agency. PLM aims to digitally transform and optimise regulatory procedure management as well as data submission and reuse throughout the product lifecycle. The value stream works with EMA partners and stakeholders to deliver systems and services for the ultimate benefit of public and animal health in the EU.

PLM’s vision is to enable data-driven, efficient and digitally connected end-to-end product lifecycle management procedures and data exchange which offer valuable regulatory services and reliable information to citizens, healthcare providers, regulators and industry.

Karl Hamilton, departing Value Stream Owner of the Product Lifecycle Management VS, offers a perspective on journey of the creation, evolution, and advancement of EMA’s PLM value stream over the past three years. 

“The goal of PLM is to provide valuable services, data and information exchange for the benefit of public and animal health.  Over the past two years, we have been building foundational services, such as the Product Management Service (PMS), a modern Regulatory Procedure Management system (IRIS), data-driven Electronic Application Forms (eAF) and the electronic Product Information (ePI) system, all leveraging standards for data storage and exchange, such as ISO IDMP, FHIR and the electronic Common Technical Document (eCTD).  Together with the Union Product Database (UPD) for veterinary medicines, these systems are helping to achieve much needed regulatory efficiencies, smoother and simplified interactions with industry stakeholders as well as greater transparency and reliable information for patients and healthcare providers.”

In conclusion, Karl also highlights the key engagement opportunity for stakeholders of EMA’s Network Portfolio: “As PLM continues into a year of significant delivery, it is vitally important that stakeholders and partners continue to share their inputs through value stream contact points and Agile events, such as the public Quarterly System Demos.” 

Please share with us your thoughts on this new newsletter via plm.valuestream@ema.europa.eu.