172 Courses

Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. It provides a bridge between clinical pharmacology and epidemiology. The increasing demand for real-world evidence of the safety, efficacy and utility of medicinal products has focused greater attention on pharmacoepidemiological research. This module will help those who plan and conduct such research, and analyse and report the findings, to follow good practice.

Whether you are new to managing, maintaining or monitoring the SCR or you want to refresh your knowledge, this three-hour masterclass will cover everything you need to know and to ensure is in place and will dispel some of the myths and confusion surrounding the SCR.

Course Information In today's evolving landscape, pharmacovigilance (PV) systems face ongoing challenges due to global, national, and company-specific events. This course focuses on developing personnel equipped to navigate these complexities and improve the safe use of medicinal products. We emphasise continuous global thinking, communication, and strategic planning, ensuring adaptability across various levels. The course explores maintaining PV system functionality while adhering to regulatory requirements. Participants will apply European regulatory standards to enhance and sustain PV system effectiveness, contributing to improvement initiatives and ensuring operational integrity. The course covers PV system intricacies, regulatory compliance, and a 'systems approach' for auditors, quality assurance personnel, and PV practitioners. Through presentations and workshops, attendees gain insights into implementing and maintaining an effective PV system. Who should attend? Auditors Pharmacovigilance Quality System Managers Pharmacovigilance scientists The QPPV. Course benefits Throughout the course delegates will explore application of the legal requirements for the PV system and quality system and how to assure these systems. They will demonstrate their ability to contribute to: A systematic investigation of the pharmacovigilance system and its quality system Examination of how the pharmacovigilance system and quality system interact to achieve compliance. The risk-based approach to auditing the PV system and quality system The maintenance of 'inspection readiness' Explore how to investigate the complex PV system Discussions about how to monitor and maintain the PV system and assure compliance. Course Objectives Clarify what has to be done: Explore application of the legal requirements. Explore how to do what has to be done: Adopt a systemic approach to systematically investigate or implement and maintain the PV system and quality system Examine how a compliant PV system and a compliant quality system interact to achieve compliance with regulatory requirements for PV Explore how to investigate the complexity of the PV system. Discus how to identify what is missing or what needs to be improved: Discuss how to monitor and maintain the PV system and assure compliance. This course will assist delegates with: An understanding of key system principles, A practical approach to implementing, maintaining and monitoring the PV system and its quality system A procedure to share expertise to increase efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas - Share knowledge and experiences - Solve specific problems.  By the end of the course delegates will be able to: Understand better the pharmacovigilance system, its quality system and how the components interact to achieve the objectives of pharmacovigilance Investigate, and analyse the pharmacovigilance system and to identify what is missing and what needs to be improved. Tutors Tutors will be comprised of (click the photos for biographies): Jana Hyankova Head of PV Department, IVIGEE Services a.s. Programme Please note timings may be subject to alteration. Day 1 08:30 Welcome, registration, course objectives and introduction to work groups Housekeeping notices, meet other delegates, explore how to work in your work group, course objectives. Clarify the definition and objectives of Pharmacovigilance. 09:30 The Regulatory Framework for Pharmacovigilance Identify the relevant regulations and directives. Explore GVP guidance, structure of the modules and standard format of each module. 10:00 The Pharmacovigilance System Exploration of how to organise what has to be done, communications. Exploration of the structures and processes for pharmacovigilance. 10:30 Break 11:00 Workshop 1 and Feedback Exploring an organisational model of the pharmaceutical company- cooperation between PV and other stakeholders. 12:00 The Quality System for pharmacovigilance Exploration of the structures, processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 13:00 Lunch 14:00 Workshop 2 and Feedback The quality system puzzle. Explore the organisation of the PV quality system and how it interacts with the PV system. 14:30 The Quality System for pharmacovigilance Exploration of the structures processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 15:00 Description of PV System 15:30 Break 15:30 Workshop 3 and Feedback The quality system puzzle Explore the organisation of the PV quality system and how it interacts with the PV system. 16:00 The Pharmacovigilance Safety Master File Construction of the Pharmacovigilance System Master File and its purpose. 17:00 Workshop 3 and Feedback Description of PV System. 18:00 End of Day Day 2 08:30 Drug Safety in the Clinical Trial Environment - Part 1 Information flow and responsibilities of the sponsor. 09:30 Workshop 4 and Feedback Drug Safety in the Clinical Trial environment: Information flow and responsibilities of the sponsor. 10:30 Break 11:00 Drug Safety in the Clinical Trial Environment - Part 2 Information flow and responsibilities of the sponsor. 12:00 Lunch 13:00 Workshop 5 and Feedback Drug Safety in the clinical trial environment: Information flow and responsibilities of the sponsor. 13:30 Processing of Safety Data Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management. 15:00 Break 15:30 EudraVigilance Exploration of how EudraVigilance supports the PV system. 16:15 Signal Detection and Evaluation/Risk Benefit Assessment: Pharmacovigilance Risk Assessment Committee (PRAC): What is a signal? What are the regulatory requirements? How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection. Risk benefit assessment. 17:00 Risk Management Plans A cornerstone of Pharmacovigilance safety communications, direct healthcare professional communication 18:00 End of Day Day 3 08:30 The Pharmacovigilance Risk Assessment Committee (PRAC) Exploration of how good practice is achieved. Composition, role and responsibilities. Examples of referrals. 09:15 Development Safety Update Reports (DSURs): Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:30 Break 11:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 12:00 Workshop 6 and Feedback To explore the compilation and submission of the PSUR. 13:00 Lunch 13:30 Role of the QPPV Exploration of the legal responsibilities of the QPPV and the MAH. 14:30 Break 15:00 Workshop 7 and Feedback To explore the challenges faced by the QPPV. 15:30 End of course Extra Information Face-to-Face Course Course material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device< Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking You will need a stable internet connection, a microphone and a webcam. CPD Points 23 Points   Development Level Develop

Level 3 Award in Assessing Competence in the Work Environment Course was known as A1 course. Learn More Academy provides Assessor distance learning or classroom based course in different locations in the UK. Level 3 Assessing Competence in the Work Environment is for practitioners who assess the demonstration of competence in a work environment using the following assessment methods: observation/examining work products/oral questioning and discussion/use of witnesses/learner statements/Recognition of Prior Learning (RPL). ABOUT THIS COURSE: Assessing Competence in the Work Environment is for practitioners who assess the demonstration of competence in a work environment using the following assessment methods: observation/examining work products/oral questioning and discussion/use of witnesses/learner statements/Recognition of Prior Learning (RPL). UNIT COVERED: Level 3 Award in Assessing Competence in the Work Environment (Assessor) course consists of the following 2 Units: Unit 1: Understanding the principles and practices of assessment D/601/5313 Unit 2: Assess occupational competence in the work environment H/601/5314 COURSE OUTLINE: • Understand the principles and requirements of assessment • Understand how to involve learners and others in assessment • Understand different types of assessment method • Understand the legal and good practice requirements in relation to assessment • Be able to plan the assessment of occupational competence • Understand how to plan assessment • Understand how to make assessment decisions • Be able to make assessment decisions about occupational competence • Be able to provide required information following the assessment of occupational competence • Understand quality assurance of the assessment process • Understand how to manage information relating to assessment • Be able to maintain legal and good practice requirements when assessing occupational competence ENTRY REQUIREMENT: There are no formal requirements for this course, however, candidates should be working in, or working towards a role in quality assurance. However to undertake the full Award candidates are required to have access to two learners. COURSE ASSESSMENT: No closed book exam is required and there is no formal examination is required, however at the end of the course you need to submit a portfolio assignment with related documents. WHY YOU CHOOSE US: • Qualified and long experienced trainers. • Recognised Training Provider. • Tutors support available. • 99% pass rate. • Very reasonable course fees. • No hidden cost/fees. • Quick result and certificates . • We have dedicated team to support you. • Career advise available if needed. HOW MUCH THIS COURSE COST? Level 3 Award in Assessing Competence in the Work Environment (TAQA) course will cost for Online Distance Learning £309.99 and for Webinar Classroom based course £429.99 There is no any hidden fess/cost.

At the end of this course you will have an understanding of health and safety legislation and you'll be able to list common causes of accidents. You'll also be able to understand good practice in relation to electricity and describe the use of safe manual handling techniques as well as be able to describe good practice associated with COSHH regulations, be able to describe your action in the event of a fire and also you will know how to deal with an accident.

Essential knowledge – for counsellors, psychotherapists and anyone else working with distressed people This new online course is designed to stimulate deeper thinking about the ethical dilemmas and professional difficulties you may encounter when working with people suffering emotional distress. It gives you sound principles to remember and realistic guidelines to follow whenever difficult ethical situations arise. Whilst primarily designed for counsellors and psychotherapists, anyone interested in thinking more clearly about ethical matters, including social workers, occupational therapists, mental health workers, medical and legal professionals, can complete the course. The guidance offered is not a list of static ‘rules’ but a framework of interlocking ideas and insights through which it is possible to create clear and reasonable codes of professional conduct to help ensure we act ethically. The discussions between the tutors raise important considerations – deriving from real case histories – and give you valuable insights about the evolution of ethical behaviour and the nature of ethical problems today. Why this course is needed We live in a world that, despite technological progress, seems to have lost its moral compass. It should go without saying that all therapists should act ethically with their patients, but some don’t. The consequences of this can prove distressing and even damaging for the client involved, and, for the practitioner, can mean anything from public censure, suspension from practice, or full-scale striking off. So, in addition to following guidelines and a code of practice, therapists need to develop a sound inner intuition of what the right thing to do is in any particular circumstance. However, developing this intuition requires us to escape from our mental pigeon-holes so that we can develop richer patterns of thought, through consideration of a wide range of potential pitfalls and ethical dilemmas, to draw upon and return to throughout our professional lives. What will you explore The foundations of ethics Ethics and human nature The difference between ethics, morals and the law The reason ethical dilemmas arise The HG Code of Ethics Examples of modern ethical quandaries Living in a ‘victim culture’ that’s obsessed with blaming Why ethical behaviour is socially conditioned The importance of learning from mistakes Why relying on systems can inhibit flexibility of thought and behaviour Why organisational rigidity drives bureaucracies to behave unethically What determines our individual nature, character and mental health The assumptions we make that get in the way of ethical decision making Typical case histories dealt with by the HGI’s Registration and Professional Standards Committee Ethics: needs and wants Ethics, tribalism and political correctness Our inbuilt range of moral emotional responses The illusion of shared perceptions Three ethical safeguards arising from the Human Givens approach The importance of spare capacity when helping others The danger of patients putting therapists on a pedestal Why technology, using artificial intelligence, raises ethical questions Accredited CPD certificate and much more… Counts towards a Diploma By taking this course, you could be on your way to completing Part 1 of the Human Givens Diploma – a flexible, part-time psychotherapy course which will deepen your psychological knowledge and increase your ability to help people effectively and quickly.  Course Programme Part 1The nature of ethical problems Part 2Ethical Foundations Part 3Practitioners Code of Conduct Part 4Case Histories What's included? 24 Videos 30 Quizzes Life-long access CPD Certificate Course format This online ethics course is delivered by four distinguished Fellows of the HGI, Sue Saunders, Ian Thomson, Ivan Tyrrell and Denise Winn – their discussions provide much food for thought and draw on real case histories that have come before the HGI’s Registration and Professional Standards Committee. As with all our online courses, you are required to answer multiple-choice questions designed to add to your knowledge and deepen your understanding: an enjoyable, thought-provoking part of the learning process. Once you have completed the course, you will receive an Accredited CPD certificate, which counts towards the Human Givens Diploma. This course has been independently assessed by the internationally recognised CPD Standards Office for 6 hours of CPD training. Meet your tutors Ivan Tyrrell Ivan Tyrrell worked for many years as a psychotherapist and now spends most of his time lecturing and writing. Read more Sue Saunders Sue has worked in training, coaching and psychotherapy for over 30 years. She also has extensive experience in the corporate world. Read more Ian Thompson Ian Thomson is the former deputy chair of the HGI Registration and Professional Standards Committee Read more Denise Winn Denise is a journalist, editor and author specialising in psychology – who has also practised as a human givens therapist since 2000. Read more

This bundle will transform your approach to the inclusion of autistic children with all of our most effective course modules

Giving a successful presentation can be one of the hardest parts of many people's jobs. Ultimately preparation will be the key to success when it comes to giving a presentation, but how do you make sure you are prepared enough? What about the structure? The content? How should you use visual aids? Being a successful presenter also involves understanding your audience, their expectations and needs. This course covers the common mistakes people make when preparing for and giving a presentation so you can avoid these, as well as going over good practice and providing some practical advice that you can put to good use the next time you have a big presentation to make.

Ensuring effective customer due diligence is vital in managing the risk of all forms of financial crime. However, this presents increasing challenges, particularly when dealing with customers remotely. 3-hour live, instructor-led virtual workshop Suitable for anyone who wants to learn more about KYC/CDD Gain a solid understanding of and practical ability to deliver robust due diligence Earn a certificate of completion and receive a £100 discount on the ICA Certificate in KYC and CDD (if you choose to go on to further study). What will I learn? CDD - what is it and why bother? The risk-based approach to CDD CDD requirements, skills, and good practice Core 'Know Your Customer' frameworks What is like working in 'Know Your Customer'

This half day course is designed to help participants who need to write or revise policies and procedures for their organisations. It will help them to develop effective structures for the writing and design and ensure that they meet key legal and good practice requirements on some of the most important policies such as health and safety, equal opportunities and financial procedures. It will also look at the process of consultation and implementation so that the policies obtain “buy-in” and commitment from staff and volunteers.