Webinar: FHIR capabilities for IDMP
Unlocking IDMP Data and harnessing FHIR Capabilities for Compliance and Beyond
This webinar is a collaboration between Iperion, a Deloitte business, and Edenlab solution - the Kodjin FHIR Server. During this event, you will learn more about a unique end-to-end solution that simplifies the process of unlocking IDMP data from source documents and harnessing FHIR capabilities.
European In Vitro Diagnostic Device Regulation (EU-IVDR)
A significant upgrade of the regulatory framework
The road to EU-IVDR compliance is complex and time consuming. This means that manufacturers must start early with preparing for EU-IVDR and act within proper timing to allow a smooth transition to the EU-IVDR.
Global product labeling as the lynchpin of Life Sciences’ data-driven future
The indisputable case for structured content authoring and management – ensuring more repeatable and reliable output with inherent traceability
A more streamlined, dependable, data-driven approach on label management is the only option manufacturers and marketing authorization holders have if they want to maximize their international opportunity while containing both cost and risk.
Whitepaper: Specific RIMS upgrades as data-driven submissions ambitions grow
Considerations to comply with the latest regulatory requirements and drive new operational efficiency and strategic intelligence
Considerations for RIMS upgrades as data-driven submissions ambitions grow. Recommendations and emerging leading practices as Life Sciences organizations look to comply with the latest regulatory requirements and drive new operational efficiency and greater strategic intelligence.
A practical guide to IDMP preparations
Essential next steps to maximise the benefits of a data-driven future
IDMP is an unprecedented opportunity to transform regulatory product data management and unlock new efficiencies. In this whitepaper we present the next steps for aligning technology, process, operating models, change activities, and data strategies to maximize benefits.
Clinical Trial Regulation preparedness
Iperion Life Sciences
Iperion life sciences consultancy becomes part of Deloitte
Our commitment to promote data standardisation for better patient outcomes
Life Sciences Consultancy will become a Deloitte business. Combining our forces to make a greater contribution to the accelerated approval of new or improved medicines as well as the provision of high-quality information to patients and the healthcare sector.
European Medical Device Regulation
The complexity of qualification and classification
The European Medical Device Regulation 2017/745 (EU-MDR) provides a regulatory framework with the purpose of ensuring safe and effective performance of medical devices before and after these are brought to the EU market.