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286 Pharmacology courses delivered Online

CT10: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials

By Zenosis

An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.

CT10: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials
Delivered Online On Demand3 hours
£149

CT03: ICH Good Clinical Practice

By Zenosis

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.

CT03: ICH Good Clinical Practice
Delivered Online On Demand3 hours
£149

CT04: An Introduction to Clinical Trial Preparation and Design

By Zenosis

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.

CT04: An Introduction to Clinical Trial Preparation and Design
Delivered Online On Demand4 hours
£129

SUB09: The New Drug Application (NDA) for Marketing Approval in the USA

By Zenosis

The New Drug Application (NDA) is the regulatory vehicle through which sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for marketing and sale in the USA.

SUB09: The New Drug Application (NDA) for Marketing Approval in the USA
Delivered Online On Demand3 hours 30 minutes
£129

CT09: Good Clinical Practice Inspections and Audits

By Zenosis

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.

CT09: Good Clinical Practice Inspections and Audits
Delivered Online On Demand2 hours 30 minutes
£126

SUB05: Electronic Common Technical Document (eCTD)

By Zenosis

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.

SUB05: Electronic Common Technical Document (eCTD)
Delivered Online On Demand2 hours 30 minutes
£126

VAL01: Introduction to Validation

By Zenosis

Validation of equipment, services, systems and processes is vitally important in the medicines and healthcare products industries. Regulatory authorities require documented evidence that manufacturing processes will consistently result in products meeting predetermined quality standards. This module provides an introduction to validation and to the regulations and guidance that apply to it. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.

VAL01: Introduction to Validation
Delivered Online On Demand1 hour 30 minutes
£99

VAL03: Commissioning and Installation Qualification

By Zenosis

Before equipment can be used routinely in production, it must first be commissioned and, if necessary, undergo Installation Qualification (IQ). This module describes commissioning and IQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.

VAL03: Commissioning and Installation Qualification
Delivered Online On Demand1 hour 30 minutes
£99

VAL02: Validation Plans and Documentation

By Zenosis

Essential to validation is the provision of documented evidence verifying that manufacturing processes will consistently result in products meeting predetermined quality standards. This module describes the purpose, content and use of validation master plans, project validation plans, and other documentation for validation projects in the medicines and healthcare products industries. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.

VAL02: Validation Plans and Documentation
Delivered Online On Demand1 hour 30 minutes
£99

VAL05: Equipment Cleaning Validation

By Zenosis

Manufacturers of medicines and healthcare products must establish, validate and maintain an equipment cleaning programme. This is a regulatory requirement because validated cleaning procedures contribute to the assurance of product purity and safety. This module provides a comprehensive account of equipment cleaning validation requirements and procedures. It follows the work of a pharmaceutical company's validation team as they establish and validate the cleaning program for a new production line.

VAL05: Equipment Cleaning Validation
Delivered Online On Demand1 hour 30 minutes
£99