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273 Courses

SUB04: Preparing Submissions in the Common Technical Document (CTD) Format

By Zenosis

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.

SUB04: Preparing Submissions in the Common Technical Document (CTD) Format
Delivered Online On Demand1 hour 30 minutes
£74

SUB01: Orphan Drug Designation in the USA and Europe

By Zenosis

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.

SUB01: Orphan Drug Designation in the USA and Europe
Delivered Online On Demand1 hour 30 minutes
£74

ICT01: Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures

By Zenosis

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.

ICT01: Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures
Delivered Online On Demand1 hour 30 minutes
£74

PKPD01: An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration

By Zenosis

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.

PKPD01: An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration
Delivered Online On Demand1 hour 30 minutes
£74

GMP04: Good Manufacturing Practice for the Warehouse

By Zenosis

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.

GMP04: Good Manufacturing Practice for the Warehouse
Delivered Online On Demand1 hour 30 minutes
£74

GMP01: An Introduction to Good Manufacturing Practice for Medicinal Products

By Zenosis

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.

GMP01: An Introduction to Good Manufacturing Practice for Medicinal Products
Delivered Online On Demand1 hour 30 minutes
£74

SUB02: The European Centralised Procedure (CP)

By Zenosis

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.

SUB02: The European Centralised Procedure (CP)
Delivered Online On Demand1 hour 30 minutes
£74

CT07: An Introduction to Clinical Trials and Drug Development

By Zenosis

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.

CT07: An Introduction to Clinical Trials and Drug Development
Delivered Online On Demand1 hour 30 minutes
£74

PV04: Signal Detection and Management in Pharmacovigilance

By Zenosis

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.

PV04: Signal Detection and Management in Pharmacovigilance
Delivered Online On Demand1 hour 30 minutes
£74

PV05: Risk Management Planning for Medicinal Products

By Zenosis

Proactive risk management is a major component of good pharmacovigilance practice. This module sets out the principles of risk management planning and outlines regulatory requirements for risk management plans in regions that are major markets for medicinal products.

PV05: Risk Management Planning for Medicinal Products
Delivered Online On Demand1 hour 15 minutes
£61