In July 2024, the European Medicines Agency (EMA) issued its revised guideline on Good Pharmacovigilance Practices (GVP) Module XVI and its Addendum II. The update places greater emphasis on the involvement of healthcare professionals and patient representatives in the design,…

Have you ever wondered why Informed Consent Forms (ICFs) and patient information sheets in clinical trials are so lengthy? Is this level of detail truly necessary? What legal requirements must be included, and could these be simplified without losing essential…

There is evidence that confidence in science and associated sources of information has been eroding.  Many factors may be seen as having contributed to this alarming trend, resulting in difficulty in distinguishing integrity and reliability of information. Some of this…

Patient-centred drug development has made huge leaps forward in recent years and an increasingly better-informed patient community is embracing shared-decision making as the norm when it comes to their healthcare. But how can we ensure that they are kept in…

Risk mitigation strategies (RMS) are essential for enhancing patient safety and ensuring effective healthcare delivery. However, their success depends on translating theoretical frameworks into practical, patient-centred interventions. Patient empowerment has been increasingly recognised as a crucial dimension of healthcare, improving…

Informed consent is a cornerstone of ethical medical practice, ensuring that participants are fully aware of the risks and benefits associated with treatments in clinical research studies. This presentation explores the critical role of clear communication in conveying safety and…