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The CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. In the European Economic Area, the USA and Canada, the CTD, in its electronic format (eCTD), is mandatory for all applications for marketing approval and all subsequent related submissions. The CTD is accepted in many other countries, being mandatory for new prescription medicines in some. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

This module provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials. It specifies the purpose of trials, outlines their features, and identifies codes and regulations that apply to them. Finally, it describes the environment of cost control in which the modern pharmaceutical industry operates.

This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.

This course is an advanced Practitioners Course. Every practitioner should have fluid wisdom of the Aura and Chakra system. Because it is this anatomy that fuels our holistic. Wellness. And unwellness. This course is suitable for beginners and experienced therapists, as the course explores all the foundation work and advanced.