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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.

Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as ‘orphan drugs’ because of their commercial unattractiveness. Development of such products is successfully encouraged through incentives offered by regulatory authorities. To qualify for important incentives, the sponsor of a drug must gain ‘orphan designation’ for its use in an indication. This module describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area.

The Centralised Procedure (CP) is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA) on the basis of a single application. In the CP, one successful application leads to a marketing authorisation being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products.

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.

Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. The rules may be written into law or set out in guidance documents from regulatory authorities. Regulators will not allow medicinal products to be placed, or to remain, on the market in their country unless the products can be shown to be manufactured in compliance with GMP. To this end, they carry out inspections of manufacturing plants. Companies that persistently commit serious breaches of GMP requirements have suffered huge fines.

The warehouse plays a crucial role in a medicinal products factory. This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them.

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.

Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug. In this module we describe the role of in-vivo PK and PD studies in a drug development programme, set out the uses to which the findings can be put, and discuss their implications for clinical development and application for marketing approval.

PTSD & Trauma Counselling with EMDR Therapy Level 3 Embark on a comprehensive exploration of trauma healing with our PTSD & Trauma Counselling with EMDR Therapy Level 3 course. This course provides a profound understanding of PTSD, the principles and applications of EMDR therapy, and specialized approaches for multiple traumas and children. Learning Outcomes: Gain a foundational understanding of Post-Traumatic Stress Disorder (PTSD) in Trauma Counselling. Acquire knowledge about the fundamentals of Eye Movement Desensitization and Reprocessing (EMDR) in Trauma Counselling. Learn effective techniques for preparing clients for EMDR in Trauma Counselling. Master the process and application of EMDR Therapy in Trauma Counselling. Understand the approaches for applying EMDR therapy for multiple traumas in Trauma Counselling. Explore the use of EMDR therapy for children in Trauma Counselling. More Benefits: LIFETIME access Device Compatibility Free Workplace Management Toolkit Key Modules: Introduction to PTSD: Understand the basics, symptoms, and impact of PTSD in the context of Trauma Counselling. Introduction to EMDR: Learn about the principles and history of EMDR therapy and its relevance in Trauma Counselling. Preparing Clients for EMDR: Discover techniques to effectively prepare clients for EMDR therapy in Trauma Counselling. EMDR Therapy: Explore the methodology and therapeutic process of EMDR and its effectiveness in Trauma Counselling. EMDR for Multiple Traumas: Gain insights into applying EMDR therapy for individuals with multiple traumatic experiences in Trauma Counselling. EMDR for Children: Learn about the adaptations and considerations required for using EMDR therapy with children in Trauma Counselling.