Overview Join our Bioinformatics course and discover your hidden skills, setting you on a path to success in this area. Get ready to improve your skills and achieve your biggest goals. The Bioinformatics course has everything you need to get a great start in this sector. Improving and moving forward is key to getting ahead personally. The Bioinformatics course is designed to teach you the important stuff quickly and well, helping you to get off to a great start in the field. So, what are you looking for? Enrol now! You Will Learn Following Things: Learn strategies to boost your workplace efficiency. Hone your skills to help you advance your career. Acquire a comprehensive understanding of various topics and tips. Learn in-demand skills that are in high demand among UK employers This course covers everything you must know to stand against the tough competition. The future is truly yours to seize with this Bioinformatics. Enrol today and complete the course to achieve a certificate that can change your career forever. Details Perks of Learning with IOMH One-to-one support from a dedicated tutor throughout your course. Study online - whenever and wherever you want. Instant Digital/ PDF certificate 100% money back guarantee 12 months access This course covers everything you must know to stand against the tough competition. The future is truly yours to seize with this Bioinformatics. Enrol today and complete the course to achieve a certificate that can change your career forever. Process of Evaluation Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo. Certificate of Achievement After completing the Bioinformatics course, you will receive your CPD-accredited Digital/PDF Certificate for £5.99. To get the hardcopy certificate for £12.99, you must also pay the shipping charge of just £3.99 (UK) and £10.99 (International). Who Is This Course for? This Bioinformatics is suitable for anyone aspiring to start a career in relevant field; even if you are new to this and have no prior knowledge, this course is going to be very easy for you to understand. On the other hand, if you are already working in this sector, this course will be a great source of knowledge for you to improve your existing skills and take them to the next level. This course has been developed with maximum flexibility and accessibility, making it ideal for people who don't have the time to devote to traditional education. Requirements There is no prerequisite to enrol in this course. You don't need any educational qualification or experience to enrol in the Bioinformatics course. Do note: you must be at least 16 years old to enrol. Any internet-connected device, such as a computer, tablet, or smartphone, can access this online course. Career path The certification and skills you get from this Bioinformatics Course can help you advance your career and gain expertise in several fields, allowing you to apply for high-paying jobs in related sectors. Course Curriculum Module 01: Introduction to Bioinformatics Introduction to Bioinformatics 00:10:00 Module 02: Topics in Computational Genomics Topics in Computational Genomics 00:10:00 Module 03: Algorithms in Computational Biology Algorithms in Computational Biology 00:10:00 Module 04: Applied Bioinformatics Tools Applied Bioinformatics Tools 00:10:00 Module 05: Structure and Function of Proteins Structure and Function of Proteins 00:10:00 Assignment Assignment - Bioinformatics 00:00:00
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.
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.
This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review.