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98 Drug Safety courses delivered Online

SAM04: Marketing of Prescription Drugs in the USA – Interactions with Healthcare Professionals

By Zenosis

The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases.

SAM04: Marketing of Prescription Drugs in the USA – Interactions with Healthcare Professionals
Delivered Online On Demand1 hour
£95

SAM02: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA

By Zenosis

In this course we explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.

SAM02: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA
Delivered Online On Demand1 hour 30 minutes
£95

SUB03: The Mutual Recognition Procedure (MRP)

By Zenosis

his module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the MRP.

SUB03: The Mutual Recognition Procedure (MRP)
Delivered Online On Demand2 hours
£98

SUB11: The Decentralised Procedure (DCP)

By Zenosis

This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP.

SUB11: The Decentralised Procedure (DCP)
Delivered Online On Demand2 hours
£98

CT08: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure

By Zenosis

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.

CT08: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
Delivered Online On Demand2 hours
£98

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

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

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

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
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