Product Lifecycle Management (PLM) Value Stream Deep-Dive Webinar
EMA is pleased to announce a public webinar for regulators and medicines developers interested in learning more about what the Agency's Product Lifecycle Management (PLM) value stream is working on and what it aims to achieve.
PLM is one of three value streams covering the product lifecycle implemented by the Agency as part of its agile transformation. 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 to manage the authorisation and lifecycle of medicinal products and medical devices within the Agency's remit for the ultimate benefit of public and animal health in the EU.
This webinar aims at illustrating the interconnections between the various digital products being delivered. In addition, further insights into the approach taken to enhance product lifecycle management technology in order enable more efficient and effective medicine regulation will be outlined.
During the webinar, participants will learn more about the value stream's vision and roadmap towards a data centric target operating model for end-to-end data capture, processing and re-use, as well as how PLM products and solutions contribute to this model.
Featured PLM products and solutions:
Solutions for Human & Veterinary medicinal products;
- electronic Application Form (eAF);
- Regulatory Procedure Management (RPM).
Solutions for Human medicinal products:
- eCTD v4.0 implementation;
- Expert Panels for Medical Devices (EXPAMED).
- electronic Product Information (ePI).
- Product Management Service (PMS);
- Product Data Management User Interface (UI);
Solutions for Veterinary medicinal products:
This is an opportunity to enhance your understanding of the work of the value stream and stay informed about the latest in this area, ask questions and interact with EMA teams responsible.
The registration form is available here:
Registration will remain open until the start of the webinar.
Please feel free to send your questions in advance via Slido using the specific event code: #PLMVS-QA.