3339 Healthcare courses delivered Online

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.

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.

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.

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.

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.

Family Law, Family Support Worker and Safeguarding Diploma Transform your career with our Family Law, Family Support Worker and Safeguarding Diploma. Become the Family Support Worker that families trust. Drive change as an informed and skilled Family Support Worker. Learning Outcomes: Master key Family Law principles relevant to a Family Support Worker. Address discrimination effectively as a Family Support Worker. Develop essential qualities intrinsic to an effective Family Support Worker. Deliver crisis support with a Family Support Worker's skill set. Apply safeguarding laws in your role as a Family Support Worker. More Benefits: LIFETIME access Device Compatibility Free Workplace Management Toolkit Key Modules from Family Law, Family Support Worker and Safeguarding Diploma: Introduction to Family Law: Acquire Family Law basics essential for a Family Support Worker's role. Discrimination in Family Law: Identify and combat discrimination through a Family Support Worker's legal understanding. Qualities of a Family Support Worker: Cultivate the character and competencies necessary to excel as a Family Support Worker. Supporting Families in Crisis: Equip yourself with crisis management techniques tailored for a Family Support Worker. Laws and Guidance on Safeguarding: Integrate safeguarding laws and guidance into your practices as a Family Support Worker. Safeguarding of Vulnerable Adults: Ensure the well-being of vulnerable adults by applying principles aligned with a Family Support Worker's responsibilities.

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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.