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A clinical trial, particularly a late-phase commercial study, is a major project requiring collaboration between the sponsor and staff or contractor, on the one hand, and the clinical investigator(s) and other healthcare professionals on the other. Good communication among all parties is essential. In this short course we introduce the major roles in a typical clinical research project and outline their duties.

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 in applications for marketing approval. The International Council for Harmonisation's guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice. In this short course we describe the ICH’s role in the harmonisation of regulations, introduce its guideline E6, and set out the principles of GCP.

Clinical trial design establishes the framework upon which the clinical trial process will be conducted, and sets the objectives of the trial. The application for marketing approval, submitted to the regulatory authorities, will provide clinical data reflecting the trial design. Since trial design impacts the whole drug development process and lifecycle, particular care and due diligence is essential. This short course provides an overview of the main types of study design.

In this short course we present an overview of the main principles of GMP, and we outline some things that manufacturing personnel need to do to comply with requirements. We identify the principal goals of GMP as: prevention of contamination; prevention of mix-ups; scrupulous documentation; validation and maintenance of processes and equipment; quality assurance by an independent unit; and training. We place GMP in the context of a company’s quality management system.

Comprehensive documentation of procedures, formulas, work instructions, and specifications, and thorough recording of batch data, are fundamental requirements of GMP. In this short course we explain why documentation is so important, identify different types of document required, and set out some simple rules for recording and correcting data.

The main subject areas of the course are: Good practice in asbestos removal or remediation Asbestos Removal Control Plans Air sampling for asbestos Enclosures, clearance air monitoring and reporting

Discover the art and science of aromatherapy with our Level 3 Diploma program. Gain comprehensive knowledge of essential oils, their therapeutic properties, and practical skills to promote holistic well-being. Enroll now to embark on a rewarding journey towards becoming a certified aromatherapist.

Gain the skills and credentials to kickstart a successful career and learn from the experts with this step-by-step

If you are a Mental Health First Aider or MHFA Champion you have skills for life that support you and the people around you. We believe that mental health should be treated equally to physical health - and just like physical first aid, Mental Health First Aid training should be kept up to date. The four-hour MHFA Refresher course will empower you to: Keep your awareness of mental health supports current Update your knowledge of mental health and what influences it Practice applying the Mental Health First Aid action plan Outline About mental health Stress and factors that influence mental health Mental health continuum and stigma Frame of reference and non-judgement Reintroducing ALGEE Warning signs of mental ill-health Depression and anxiety Suicide and first aid for suicidal crisis Psychosis and first aid for severe psychotic episodes Practising our MHFA sills Self-care, wellbeing and recovery

Explore the intricate web of emotions, behaviors, and neurological processes underlying alcohol and drug addiction. Uncover the psychological mechanisms driving substance dependence and gain insights into effective intervention strategies. Delve into the complex terrain of addiction psychology for a comprehensive understanding of its impact on individuals and society.