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 Medical 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 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
Intensified Scrutiny, Traceability, Harmonization, Transparency & Oversight
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.
Working at Deloitte
Data Governance in Life Sciences
Evolving, to a data-driven organisation, requires data that can be trusted, across the entire organisation. Iperion is eager to support your evolution and ensuring you get more value from your data.
The implementation of ISO IDMP will change the way of communication with the regulators. Based on experience, we know that this transformation takes time, as it requires buy-in from multiple stakeholders, adaptation of processes and technological landscape. Therefore, it is paramount to start now!
Regulatory Information Management (RIM)
In the age of digitalisation, a RIM system (RIMS) plays a vital role within life science industry, as a central hub of regulated information, which supports many cross-functional processes, such as manufacturing, R&D, clinical trials, pharmacovigilance, quality assurance, etc.
Medical Devices & In Vitro Diagnostics
Providing a wide range of strategic and hands-on quality and regulatory support services in Device Lifecycle Support, Quality and Regulatory Automation and Training.
Operate for Life Sciences
Operate services offer specialised operational support to the life sciences industry for data and label management, utilising automations and tooling for optimal efficiency and pairing that with in depth industry knowledge to work collaboratively with our clients as an integral part of their team.
Clinical Trial Regulation preparedness
Clinical trial sponsors are required to undertake complex organisational transformation to ensure compliance with the EU CTR. This includes defining and executing optimal strategies for EU CTR implementation and ensuring they are and remain responsible businesses.