114 Healthcare IT courses

Health Care: Menstrual Health Short Diploma Master Menstruation fundamentals in Health & Care. Understand PMS intricacies. Tackle Menstrual Health disorders. Elevate Menstrual Hygiene. Explore life-stage Menstrual Health and advocacy. Learning Outcomes: Identify Menstruation processes in Health & Care. Analyze PMS symptoms for Menstrual Health. Examine Menstrual Health irregularities. Promote Menstrual Hygiene in Health & Care. Evaluate Menstrual Health advocacy importance. More Benefits: LIFETIME access Device Compatibility Free Workplace Management Toolkit Health Care: Menstrual Health Short Diploma Course Syllabus Unveil Menstruation Fundamentals: Acquire foundational Menstrual Health knowledge. Explore menstruation's role in Health & Care. Demystify Pre-Menstrual Syndrome (PMS): Investigate PMS intricacies in Menstrual Health. Learn Health & Care management strategies. Navigate Menstrual Irregularities: Decipher Menstrual Health irregularities. Master diagnosis and treatment in Health & Care. Champion Menstrual Hygiene: Master Menstrual Hygiene essentials in Health & Care. Emphasize Women's Health & Care well-being. Decipher Life-Stage Menstrual Health: Understand Menstrual Health changes across life-stages. Examine Health & Care considerations throughout. Advocate for Menstrual Health: Grasp Menstrual Health advocacy. Champion policy changes in Health & Care settings.

The New Drug Application (NDA) is the regulatory vehicle through which sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for marketing and sale in the USA.

This module aims to provide you with effective strategies for the preparation and conduct of a clinical trial, while adhering to regulatory safety standards. Management of data for submission is also covered.

The eCTD is mandatory for all applications for marketing approval and all subsequent related submissions in the European Economic Area, the USA and Canada. Other countries intend to make its use mandatory. The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format.

The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.

Changes to the terms of marketing authorisations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the composition of products, their manufacturing processes, the way they are used, or the indications for which they are authorised. Common approaches are adopted within the European Economic Area to variations to marketing authorisations approved through the Centralised, Decentralised or Mutual Recognition Procedures. Recent legislation has substantially modified the regulatory requirements and extended them to purely national authorisations by member states. This module, which is fully up to date with the new legislation, covers the classification of variations into their several types and the regulatory requirements, guidance and procedures to be followed for each type.

This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed.

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 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.