Regulations

Healthcare regulations and compliance

Operational Readiness: Protecting Patient Care in an Era of Growing Complexity

Healthcare innovation depends not only on new therapies but also on an organization's ability to manage growing operational complexity. From advanc...

Traceability of investigational medicinal products in clinical trials and expanded access programs in real-world settings

The management of investigational medicinal products in clinical trials and expanded access programs relies on rigorous traceability throughout eve...

Traceability in IVF Laboratories: Bridging Global Standards and Ground Reality

Traceability in IVF laboratories goes far beyond the correct identification of gametes and embryos: it is the system that makes it possible to reco...

The value of KPI’s in the transplant setting: Wits Donald Gordon Centre, Johannesburg

In high-stakes transplant settings, traditional outcome indicators such as mortality, relapse, and graft-versus-host disease remain essential but i...

PDTA and Monitoring Systems as Engines of HTA: The 'cost' of appropriateness

In a healthcare context characterised by limited resources and increasing complexity, clinical appropriateness emerges as a strategic lever to ensu...

Managing multidisciplinarity: organisation as a driver of safety and clinical quality

The transition from multidisciplinarity as a 'spontaneous' practice to a governed organisational process is one of the central challenges of modern...

Case study of organisational management of interfering pathways in an operating block for active organ transplantation

This work stems from the need to observe the operating block not only as a technical site of the surgical act, but as a dynamic system of relations...

Quality system in medically assisted reproduction centres

The QUALITY SYSTEM in Medically Assisted Procreation (MAP) centres aims to guarantee the safety, effectiveness and traceability of treatments. Thes...

La normativa trasfusionale: Sicurezza e qualità per i pazienti

Nel mondo sanitario, la trasfusione di sangue e dei suoi emocomponenti rappresenta una procedura salvavita, ma richiede un'attenzione rigorosa alla...