Serious Incident Investigation: Implementing the New Patient Safety Incident Response Framework (PSIRF)
March 23, 2023
This national conference looks at the practicalities of Serious Incident Investigation on and Learning and how this has changed with the publication of PSIRF. The conference will also update delegates on best practice in serious incident investigation under PSIRF and ensuring the focus is on learning from improvement. There will also be a extended focus on learning, including mortality governance and learning from deaths ensuring insight and investigation findings lead to improvement. The conference will include updates from PSIRF early adopter sites. The conference update delegates on the new Patient Safety Incident Response Standards and how to review your current practice against these standards.
For manufacturers of medical devices, it is strategically advantageous to consider the regulatory and market access requirements of different systems, such as in the EU or the USA, at the beginning of the development of new products in order to save costs. In addition, there are different requirements within the EU at the level of the member states. In the first part of the workshop, small and medium-sized companies from the diagnostics industry will learn about the differences between the regulatory requirements of the US and EU systems when it comes to clinical testing of medical devices, such as diagnostics. Amko Groeneveld (novineon CRO GmbH) will provide step-by-step guidance through the requirements for generating clinical data, identifying and navigating FDA sources, and using available information.
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