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329 Courses

Clinical Herbalism Course

By Elearncollege

Clinical Herbalism Course
Delivered Online On Demand9 days
£99

Biomedical Science Course

By Elearncollege

Biomedical Science Course
Delivered Online On Demand9 days
£99

Medicines Management Course

By Elearncollege

Medicines Management Course
Delivered Online On Demand9 days
£99

CT14: Clinical Trial Safety Reporting Requirements in the EU and USA

By Zenosis

This course sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the foundation laid by our companion course CT13, Safety Reporting in Clinical Trials, and provides greater detail of specific requirements in those jurisdictions.

CT14: Clinical Trial Safety Reporting Requirements in the EU and USA
Delivered Online On Demand2 hours
£95

CT11: How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation

By Zenosis

This course sets out the procedures that sponsors need to follow to gain authorisation to conduct clinical trials under the Regulation, and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT12 sets out the procedures that sponsors need to follow to conduct authorised clinical trials in compliance with the Regulation. The two courses therefore provide an ideal foundation for understanding and complying with the new law.

CT11: How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation
Delivered Online On Demand2 hours
£95

CT13: Safety Reporting in Clinical Trials

By Zenosis

This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports.

CT13: Safety Reporting in Clinical Trials
Delivered Online On Demand2 hours
£95

SAM01: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA

By Zenosis

In this course we set out the legal framework for the regulation of advertising and promotion of prescription drugs in the USA. We identify the regulatory authorities and sources of guidance. We summarize basic requirements that advertisements and promotional labeling must meet, and we identify consequences that may follow failure to comply.

SAM01: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA
Delivered Online On Demand1 hour
£90

SAM03: Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA

By Zenosis

Unlike the great majority of other countries, the advertising of prescription drugs directly to consumers is permitted in the USA. Spending by drug companies on direct-to-consumer (DTC) advertising of prescription drugs has increased more than four-fold over two decades, with a dramatic increase in the number of TV ads. In addition, the Internet and social media platforms have increasingly enabled companies to engage more actively with the public.

SAM03: Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA
Delivered Online On Demand1 hour
£90

GLP02 - Good Quality Control Laboratory Practice

By Zenosis

The medicinal products industry is heavily regulated by governments. Within the industry’s Good Manufacturing Practice (GMP) framework, analytical laboratories engaged in quality control (QC) of starting materials, intermediates, bulk products, finished products, and packaging need to comply with relevant GMP standards. We refer to these as Good Quality Control Laboratory Practice, or GQCLP. Regulatory authorities inspect laboratories to confirm that they meet the standards. This course explains how to comply with GQCLP, and it provides advice on laboratory work in general.

GLP02 - Good Quality Control Laboratory Practice
Delivered Online On Demand1 hour
£79

GLP01 - Good Laboratory Practice

By Zenosis

The purpose of GLP is to provide assurance of the quality and reliability of nonclinical study data. GLP covers the planning, performance, monitoring, recording and reporting of studies. Regulatory authorities typically require GLP rules to be followed for nonclinical studies intended to support an application for approval of clinical research or marketing of a product containing the test item. This course outlines the history of GLP and explains why it is important, identifies the penalties that may be incurred for noncompliance, and sets out requirements that need to be met. Learners are also referred to the two main sources of GLP rules: The Organisation for Economic Co-operation and Development’s Principles on Good Laboratory Practice and US Regulation 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies.

GLP01 - Good Laboratory Practice
Delivered Online On Demand1 hour
£79