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.
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.
Incredible Things Originate from a Little Bundle Special Price Cut Offer Are you looking to enhance your Biochemical Engineering skills? If yes, then you have come to the right place. Our comprehensive courses on Biochemical Engineering will assist you in producing the best possible outcome by mastering the Biochemical Engineering skills. Get 6 CPD Accredited Courses for only £41! Offer Valid for a Limited Time!! Hurry Up and Enrol Now!!! Course 01: Biomedical Science Course 02: Biochemistry Course 03: Microbiology Course 04: Biotechnology Course 05: Lab Analyst Training Course 06: Epidemiology The Biochemical Engineering bundle is for those who want to be successful. In the Biochemical Engineering bundle, you will learn the essential knowledge needed to become well versed in Biochemical Engineering. Our Biochemical Engineering bundle starts with the basics of Biochemical Engineering and gradually progresses towards advanced topics. Therefore, each lesson of this Biochemical Engineering course is intuitive and easy to understand. Why would you choose the Biochemical Engineering course from Compliance Central: Lifetime access to Biochemical Engineering courses materials Full tutor support is available from Monday to Friday with the Biochemical Engineering course Learn Biochemical Engineering skills at your own pace from the comfort of your home Gain a complete understanding of Biochemical Engineering course Accessible, informative Biochemical Engineering learning modules designed by expert instructors Get 24/7 help or advice from our email and live chat teams with the Biochemical Engineering bundle Biochemical Engineering Curriculum Breakdown of the Biochemical Engineering Bundle Curriculum Breakdown of Biomedical Science Module 01: Introduction to Biomedical Science Module 02: Genetics and Biochemistry Module 03: Microbiology and Cell Biology Module 04: Biochemical Engineering and Enzyme Discovery Module 05:Toxicology, Pharmaceuticals and Fine Chemicals Module 06: Systems and Synthetic Biology Module 07: Global Health Challenges Curriculum Breakdown of Biochemistry Module 01: Introduction to Biochemistry Module 02: Introduction to Cells Module 03: Organic Chemist And Much More... Curriculum Breakdown of Microbiology Module 01: Introduction to Microbiology Module 02: Bacteriology Module 03: Viruses And Much More... Curriculum Breakdown of Biotechnology Module 1 - Introduction to Biotechnology Module 2- Biotechnology in the Realm of History Module 3- Molecular and Cellular Biology And Much More... Curriculum Breakdown of Lab Analyst Training Module 01: Introduction to the Course Module 02: Medical Laboratory Services Module 03: Laboratory Equipments (Part-01) And Much More... Curriculum Breakdown of Epidemiology Module 01: Understanding Epidemiology Module 02: Principles of Epidemiology Module 03: Study Design And Much More... CPD 60 CPD hours / points Accredited by CPD Quality Standards Who is this course for? The Biochemical Engineering bundle helps aspiring professionals who want to obtain the knowledge and familiarise themselves with the skillsets to pursue a career in Biochemical Engineering. It is also great for professionals who are already working in Biochemical Engineering and want to get promoted at work. Requirements To enrol in this Biochemical Engineering course, all you need is a basic understanding of the English Language and an internet connection. Career path The Biochemical Engineering bundle will enhance your knowledge and improve your confidence in exploring opportunities in various sectors related to Biochemical Engineering. Biochemical Engineer: £35,000 to £70,000 per year Process Development Scientist: £30,000 to £60,000 per year Bioprocess Engineer: £35,000 to £65,000 per year Quality Control Analyst: £25,000 to £45,000 per year Certificates CPD Accredited PDF Certificate Digital certificate - Included 6 CPD Accredited PDF Certificate for Free Hard copy certificate Hard copy certificate - £9.99 CPD Accredited Hard Copy Certificate for £9.99 each. Delivery Charge: Inside the UK: Free Outside of the UK: £9.99
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.
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