61454 Courses delivered Online

Strategies to Manage Stress and Weather Storms in the Workplace. This course is based upon the book "The Authority Guide to Emotional Resilience: Strategies to Manage Stress and Weather Storms in the Workplace" by Robin Hills (ISBN: 1909116599).

This course is for you if you work with people as a leader or manager and are looking at ways to help improve performance by developing emotional intelligence through coaching. The GROW (Goal, Reality, Options, Will) Model is a well-respected tool in coaching and this is explored to improve your questioning and listening techniques. It demonstrates the power of coaching through the use of a structure that enables questioning to flow conversationally and in a logical sequence.

The course investigates unconscious bias to develop your awareness. Training in unconscious bias will not mean that you will not have biases. They will remain, by definition, unconscious. The course seeks to build your awareness of their existence and highlights when to look out for them.

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.

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.

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.

You'll learn about the legal duties of personal licence holders, and how to deal with Licensing Authorities, along with information relating to objections, fees and hearings.

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.

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.