5887 Medicine & Nursing courses delivered Online

This module aims to provide you with effective strategies for the preparation and conduct of a clinical trial, while adhering to regulatory safety standards. Management of data for submission is also covered.

Level 5 QLS Endorsed Course | Endorsed Certificate Included | Plus 5 Career Guided Courses | CPD Accredited

The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.

The eCTD is mandatory for all applications for marketing approval and all subsequent related submissions in the European Economic Area, the USA and Canada. Other countries intend to make its use mandatory. The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format.

These qualifications are ALL fully Regulated and accepted in all schools across the UK and enables you to work with children between the ages of 5-18 years. If you are looking to become a Teaching Assistant and wish to gain the required 'recognised' qualification that's accepted in all UK schools, this is the perfect Teaching Assistant course for you. This bundle offer also includes the Level 3 Autism Qualification and the Level 3 Mental Health Qualifications at a discounted rate saving you over £700.00.

Level 5- Two Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 5 CPD Courses | Lifetime Access

Level 3 & 4 Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 5 CPD Courses | Lifetime Access