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67364 Courses

20 Web Projects with Vanilla JavaScript

By Packt

Build 20 mini frontend projects from scratch with HTML5, CSS, and JavaScript

20 Web Projects with Vanilla JavaScript
Delivered Online On Demand16 hours 7 minutes
£76.99

Easy Statistics: Linear Regression

By Packt

This course covers the fundamental topics of statistical methodology, linear regression, and ordinary least squares that every statistician needs to know.

Easy Statistics: Linear Regression
Delivered Online On Demand1 hour 33 minutes
£76.99

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

PKPD02: Conducting Pharmacokinetic and Pharmacodynamic Studies

By Zenosis

This module extends the learner’s understanding of pharmacokinetic and pharmacodynamic studies from the basics described in our companion module PKPD01, An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration. It provides detail on a variety of aspects of such studies: design, sampling, data analysis, research in special populations, and bioequivalence testing.

PKPD02: Conducting Pharmacokinetic and Pharmacodynamic Studies
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

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

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

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