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Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.
An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.
To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.
Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.
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.