Current legislation set out by the Health and Safety at Work Act along with the HSE’s updated code of practice known as L8, state that companies and building owners have a legal duty to manage Legionella. Our interactive training course is aimed at all employers and staff to assist them in identifying the danger that Legionella poses, as well as covering ways to identify and assess sources of risk from Legionella on the premises. It also gives you enough knowledge to get a Legionella control programme off the ground yourself – or make confident, informed choices when commissioning others to take this on for you.
This course explains the key elements, procedures and activities involved in successful Occupational Health and Safety Management in the workplace. The course show how professional Occupational Health and Safety Management benefits individuals and organisations. It will investigate workplace health models, including the basic criteria of the World Health Organisation model. You’ll discover the importance of a Health Needs Assessment and how it leads to the development of a Heath Management Strategy. On a more practical level, the course will look at hazards, risks, controls and ‘Safe Systems of Work’ and the role played by health risk assessments. Turning to workplace well-being, we’ll explain how to promote healthy lifestyles and positive mental health. You’ll learn how to manage absences from work, both authorised and unauthorised, how to create an official Attendance Policy, manage the return-to-work process and deal effectively with absenteeism. Finally, the course discusses the steps needed to develop and build a strong health and well-being culture, including leadership, communication, work-life balance and embracing change
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.
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.
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.
Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.