155 Courses

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.

New drug development requires major investment in capital, human resources and technical expertise. Strict adherence to regulations on testing and manufacturing standards is also required before a new drug can be marketed. One of the greatest challenges in conducting clinical trials is that of efficiency. As trials become more comprehensive, involving large numbers of participants globally, their duration is prolonged and costs increase. The longer trials last, the shorter is the patent life remaining after market approval and the longer patients must wait for the new product. This short course covers the key components of clinical trials and how these requirements interact with the drug development cycle.

In clinical trials, endpoints are measurements to evaluate the results of a new treatment, at an individual patient level. The study data can be extrapolated to patient populations on the basis of clinical similarities to patients participating in the trial. When clinical trial data have been obtained, focus is on the trial endpoints; more specifically, the focus is on whether the trial met or failed the primary endpoint specified before the trial started. The purpose and various types of endpoints are discussed in this short course.

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Informed consent in clinical research is an ethical and regulatory requirement. A research subject must enter a study voluntarily, be informed about risks and benefits, and understand the difference between investigation and treatment. Subjects must not be coerced into enrolment, nor must they be enticed by exaggerated claims of benefit. Before they can enrol, all potential subjects must agree, in writing, to participate. In addition to ethical and regulatory imperatives, the potential for litigation by subjects further highlights the importance of rigorous adherence to informed consent principles. In this short course we set out the principles and requirements and provide examples of practical issues confronting healthcare professionals and subjects.

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Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. Everyone who works in a processing, quality control, packaging, or warehouse environment for a pharmaceutical or biotechnology company, or one of their contractors, must understand why GMP is important, how it applies to them, and how to comply with it. This short course explains what GMP is and why it is important, and it gives some lessons from history. It introduces the regulations and guidance documents that are the source of GMP rules. Finally, it touches on regulatory inspections and the consequences that can arise from failure to comply with GMP requirements.

A clinical trial monitor acts on behalf of the sponsor to support investigational site personnel, verify the accuracy of data recorded, and ensure that the trial is conducted in compliance with the protocol, GCP and other study specific requirements. He or she acts as the ‘eyes and ears’ of the sponsor at the investigational site and provides the main channel of communication between sponsor and investigator. This short course explores the responsibilities of the monitor and provides insight into key challenges. We discuss assessment of investigators and investigational sites, education and trial initiation, monitoring of clinical conduct, including CRF review and source document verification, and trial close-out. We discuss noncompliance and how to deal with it.

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The professional working world has changed more rapidly than could have been envisaged at the time of the introduction of GDPR and the Data Protection Act 2018. With more people working from home post-Covid and the ever increasing risk of cyber-attacks, this short course is aimed at taking stock of current practice and risk, as well as considering ICO enforcement action and the implications of hybrid working. It is also a great recap on the rules as they stand and what you need to know to comply. The course will cover: UK GDPR - A timely reminder of the rules ICO enforcement action and what we can learn Data Protection Impact Assessments - when and how to do them Hybrid working and UK GDPR Managing cyber attacks from a UK GDPR perspective Target Audience The online course is suitable for staff of all levels, from support staff to senior partners. Resources Course notes will be provided to all delegates which may be useful for ongoing reference or cascade training. Please note a recording of the course will not be made available. Speaker Matthew Howgate, Consultant, DG Legal Matt is a non-practising solicitor who has considerable experience in regulatory issues and advising on complex issues of compliance and ethics. He is also an expert in data protection, UK GDPR and on the civil legal aid scheme. Matthew is a lead trainer on and co-developed the LAPG Certificate in Practice Management (a training programme for legal managers and law firm owners) as well as regularly providing training on legal aid Supervision, costs maximisation, data protection and security and on general SRA compliance.