Blog
Introduction to Clinical Research & GCP...online
30/05/2024
Brookwood’s popular and long standing basic training in clinical research and GCP is now available online and on demand.Introduction to Clinical Research & GCP ... online Everything is presented in plain language (English) and no previous experience is required. Personalised. Narrated and read-only options to choose from.Participants register for the course and can undertake the modules at a convenient time and place.Plenty of interactions and quizzes to check knowledge.The course consists of five modules and covers ... Product development through the traditional phases.Types of trial undertaken: human pharmacology, exploratory, confirmatory and post-approval.Terminology and methodology, including blinding and randomisation.Common trial designs.GCP Principles.Fundamental requirements of ICH GCP.Understanding the basic statistical requirements.The Trial Master File.Who should do this course?Anyone who needs to know about clinical trials and good clinical practice!This includes clinical research personnel in industry and academia, managers, administrators, and secretaries, as well as those at the clinical research site.Participants require no previous knowledge or experience of clinical trials. All methodology and terminologyis explained in lay persons language.By the end of the course, participants will have a good basic knowledge of clinical trial methodology andrequirements relating to trial conduct.Brookwood courses are dynamic and as interactive as possible. They are kept up-to-date and relevant.How it worksOnce you have registered for the course and your fees are paid, you will receive an email from Brookwood explaining the next steps.Your personal data (name/email) will be entered on to a course delivery platform.(called a learning management system, LMS) for the purposes of providing the training to you.You will need to confirm your registration for the course and set a password. You will then use the dashboard link and your password to gain access to the modules. You will click the icon for the module you wish to do. You need to complete each module to satisfactorily complete the course.The LMS allows us to see what you have viewed and when. It allows us to check that you have completed each module as required.We will issue the Brookwood ‘Certificate in Clinical Research & GCP’ when you have fully completed the training. You will also receive a separate certificate when you have completed the Fundamentals of GCP course.Course registration £495 (ex VAT) for access to all modules for a period of 6 months.A certificate will be issues on completion of each module and an overall Certificate in Clinical Research & GCP following successful completion of all modules.Order at https://www.brookwood-global.com/Courses/Introduction-to-Clinical-Research-and-GCP-onlineSpecial rates are available for group registrations. Please contact us directly.
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ICH E6(R3)
04/10/2023
The ICH E6 Good Clinical Practice Guideline was first finalised in 1996 to harmonise working practicesbetween the key clinical research regions of Europe, the USA and Japan. The guideline has really stood thetest of time, which is a testament to the fine work undertaken by the ICH Expert Working Group (EWG)and of course their foresight. Many regions and countries are now part of the ICH family and the E6Guideline has become a global standard.
New international recognition route for authorising medicines in the UK
04/10/2023
The Medicines and Healthcare products Regulatory Agency(MHRA) has created a new international recognition route for medicines, utilising pre-existing approvals from Australia, Canada, the EU, Japan, Switzerland, Singapore and the USA.