67037 Courses

This course has been designed to help you to learn about the fundamentals of resilience and to provide you with practical tools that you can apply immediately to create positive change in your life.

How to inspire others and build successful relationships. This course is designed to support professionals in business to develop communication skills through understanding and applying knowledge of personality and behaviour in the workplace. It is based upon the book "The Authority Guide to Behaviour in Business: How to Inspire Others and Build Successful Relationships" by Robin Hills (ISBN: 1912300087).

This highly practical and unique course will take you through a defined process to help make your recruitment as efficient and as effective as possible. Ways of identifying the behavioural competencies required to be successful in the role are explored so that you can draw up accurate job descriptions and profiles to define your ideal candidate. The course then investigates through online and offline options for attracting and sourcing candidates.

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.

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 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.

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.

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.