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.
Data-driven operating model is the latest buzz word for Regulatory Affairs in the pharmaceutical industry. Global developments for data continue to progress as we incrementally move towards the implementation of the ISO IDMP standards. These standards outline the parameters to comply with future health authority demands whilst also providing the framework to improve patient experience as we look towards to the Future of Health.
Global demand for (structured) medicinal product data is increasing, because of requirements and regulations such as ISO IDMP, CTR, and MDR. Furthermore, the industry recognizes the value that structured data can bring to an organization.
Data required by the Regulatory Affairs department, originates from other sources and departments. The need to collect and maintain IDMP data require clear Governance for the entire organisation. During this webinar we present our experience on Data Governance, and we share the challenges we have seen in various companies.
For many pharmaceutical companies, there is a daunting task ahead to align and maintain substance data throughout the company. During this webinar we present our experience on substance management, and we share the challenges we have seen in various companies.
Data extraction and remediation for DADI and IDMP. With EMA´s implementation of DADI, it is of utmost importance to align data and documents. Watch our webinar to learn more about data readiness, challenges and our proposed solution.
IDMP is becoming more and more reality, with the published EU implementation guides and the recent presentation of the DADI forms. EXTEDO and Iperion have joined forces to host a webinar giving the latest developments from EMA and the regulators and to navigate you through the regulatory landscape.
The EU Clinical Trial Regulation (CTR) will introduce a new Clinical Trial Information System (CTIS) that provides a collaborative platform for Sponsors and Regulators to manage trials across the EU. In this webinar we share several pitfalls and how to solve them as well as approaches for readiness.