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Learn the essentials of software development. And increase your confidence when working with developers. Why take this course? Talk with confidence about web and internet technologies Build better relationships with developers on your team Create smarter designs with a deeper understanding of technical constraints Understand the concepts behind coding without needing to code Who is it for? All UX professionals Format Online, self-paced Duration 6 weeks (recommended) Commitment 3 hours per week What you’ll learn Over 6 weeks, you’ll learn about the key concepts and processes involved in software development. You'll understand how code works, so that you can collaborate more effectively with developers. Module 1 The software landscape Understand the relationship between hardware and software. Module 2 Layers of software Dig into each layer of the tech stack, from the front-end to the back-end. Module 3 Front-end technologies Get up to speed on the roles of HTML, CSS and Javascript. Module 4 Back-end technologies Explore the back-end, APIs and common programming languages. Module 5 How developers work Learn about common development workflows, from waterfall to agile. Module 6 Effective collaboration Get practical guidance on how to work well with development teams.

Duration 1 Days 6 CPD hours This course is intended for Business professionals who are either at the managerial level, or are interested in becoming team leaders will benefit from this course. Overview Determine the roles that a manager must fill on a team, and explore the key areas of personal development. Discover how to detect silent messages through body language and other means of nonverbal communication. You will also bolster your listening skills through active listening. Discover ways of identifying problems, prioritizing problems, and implementing solutions effectively. Empower your workgroup through delegation and coaching. Discover the stages of team development and examine the need for regular team meetings. In this course, students will gain an understanding of the basic fundamentals of becoming an effective manager for their team. 1. Developing as a Manager Identify Effective Manager Roles Develop Personal Skills 2. Communicating Successfully Communicate Without Talking Manage Better by Listening Assert to Achieve 3. Cultivating Great Teams Create an Invincible Team Inspire Team Success Run Team Meetings Resolve Conflicts Positively 4. Empowering Your Workgroup Delegate For Results Coach for Achievement Optimize Staff Performance 5. Creating Successful Solutions Identify and Define the Problem Determine the Root Cause Identify a Solution Implement Solutions Decisively Additional course details: Nexus Humans Effective Management training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the Effective Management course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.

Essential skill for all mental health professionals This 2-day workshop gives you the opportunity to see demonstrated, experience, and practice the steps of this powerful technique in a small group under the careful guidance of our expert tutor… Accredited CPD Certificate : 12 hours Length 2 days (9:30am - 4:00pm) Excellent course. A brilliantly encouraging and supportive environment in which to learnHARRIET, WORKSHOP PARTICIPANT Life-changing! A great weight has been lifted off my shoulders.NURSE (PREVIOUSLY TRAUMATISED BY A CAR ACCIDENT) Why take this course We have over 20 years of experience in teaching the rewind technique to health and welfare professionals – we’ve drawn on that experience to develop a course which gives you enough time to thorough absorb and practice the technique, understand why it works and to experience it yourself, so that you leave confident in your ability to use the rewind safely and effectively. The Rewind Technique* is an effective psychological intervention for successfully treating trauma and phobias and one of the most important skills you need to master to be able to work successfully with any anxiety disorder or condition which may have developed as a result of unresolved trauma. Even the most severe phobic and post-traumatic stress (PTSD) symptoms can be successfully addressed using the the rewind technique taught on this 2-day course, which has been refined* in line with understandings from neuroscience to make it as safe and reliably effective as possible. An essential therapeutic technique to have in your therapeutic ‘toolkit’, it is important to learn and practice it under the careful guidance of our expert tutor – you will leave the course knowing how to use the rewind technique safely and effectively having watched live demonstrations, had plenty of time to practice the steps involved with fellow students, the opportunity to experience the technique yourself and more. Our workshop has limited numbers so you will have plenty of opportunities for asking questions and the tutor, who has extensive clinical experience. Using the rewind technique you can, often surprisingly quickly, detraumatise bad memories, stop flashbacks and other PTSD symptoms, cure phobias, banish nightmares and reduce anxiety so you can help the victims of abuse, rape, violence, car accidents, fire, terrorism and panic attacks, heart attacks and other life-threatening experiences. Another key benefit of this technique is non disclosure – there is no need for people to repeatedly revisit or talk about specific details of the events that have traumatised them. This helps avoid embedding the trauma further and making the situation worse – as can sometimes inadvertently happen in other therapeutic approaches to treating trauma – and helps prevent the therapist or counsellor being vicariously traumatised by what they might hear. It is also invaluable when working therapeutically with people who have suffered persistent physical or sexual abuse, and people with OCD. People suffering from other conditions, such as depression, addictions or uncontrollable anger, may have experienced a traumatic event, which needs to be successfully detraumatised in order for them to move on with their lives. As a result of our training in the rewind technique – which we have been delivering for over 20 years – our graduates have brought relief to literally thousands of people (eg. case history / PTSD Resolution). Please note This is a powerful technique, which needs to be implemented with care – we recommend you take the time to learn it in person in a small group with a skilled and highly experienced tutor who can guide you through the important steps involved, oversee you as you practise them, answer your questions and give you crucial direct feedback. The version of the rewind technique* you will learn on this course has been refined in line with understandings from neuroscience to make it as safe and reliably effective as possible. The course is taught over two days to ensure you have enough time to thoroughly absorb and practice the steps involved so that you are confident in using it and know how to do so safely and effectively with clients. You will also learn when it is NOT appropriate to use this technique and how to ensure you avoid embedding any trauma further, or making a phobia worse. Guided imagery and visualisation skills form an essential part of the rewind technique, which is why they are a requirement for attending this course. This has huge potential to change people's lives for the better. I can't wait to put what I've learnt here to good usePSYCHIATRIC SUPPORT WORKER What will you learn How to detraumatise people quickly and safely The necessary skills to treat even severe phobias Why this version of the rewind technique is so effective, and how it works Under careful guidance from the tutor, you will: revisit key skills for relaxing clients in order to successfully work using the technique walk and talk through a step-by-step breakdown of the rewind technique see a live demonstration of working with a phobia or trauma practice each stage of the rewind technique in pairs practice the entire process, with other course participants, under supervision You will also gain: Vital tools for psycho-education – both adding to your own understanding and to pass on to clients A clear understanding of the fear response and how PTSD and phobias develop The detrimental impact traumas and phobias can have on a person’s life The crucial role of the pattern-matching processes in the brain in triggering phobic responses and post traumatic stress symptoms How the main treatment techniques for treating post traumatic stress disorder (PTSD), sub-threshold trauma and phobias (including EMDR, EFT and CBT) work – their advantages and disadvantages Why the rewind technique draws on the innate ability we all have to recover from trauma Pre-disposing factors for suffering a problematic post-traumatic response (or developing a phobia) Why critical incident debriefing increases the incidence of PTSD How this version of the rewind technique has been modified to make it safer and more reliable Trauma-focused rewinding: the psycho-biological reason why this refined rewind technique works so consistently well A step-by-step breakdown of the essential stages of the rewind technique The chance to see a live demonstration of working with a phobia or trauma You will leave with: The confidence to begin using the technique ethically and safely A clear understanding of the advantages of using a non-intrusive psychological technique to treat trauma, PTSD and phobias (where the client does not have to go into details about or repeatedly ‘revisit’ what has traumatised them) What to do if a client as an abreaction Important information about when not to use this technique – and what can be done instead An understanding of how the rewind technique can be used to work with Complex Trauma and cases involving ‘freeze’, shutdown or dissociative responses How you can carefully apply this technique to relieve a huge range of anxiety disorders Greater confidence in dealing with anxiety disorders and distress caused by trauma, phobias and flashbacks An understanding of how rapidly transformative this technique can be; on the last afternoon we view a filmed therapy session (and follow up) in which Joe Griffin uses the rewind technique to relieve a young man of his severe shark phobia There is also plenty of opportunity for you to ask questions and to experience and practice, under careful guidance, the various stages of the rewind technique yourself. Who is this course suitable for? Anyone working with distressed, phobic or traumatised people, who has already taken our Guided Imagery and Visualisation workshop (and ideally the Therapeutic Power of Language workshop too) as these skills are essential components of the rewind technique. If you help traumatised people (including children) or people suffering from any form of phobia or anxiety disorder – this includes: psychotherapists, counsellors, mental health nurses, OTs, health visitors, social workers, psychiatrists, GPs, clinical psychologists, midwives, welfare officers, youth workers, hypnotherapists and those working with traumatised members of public services, such as: firefighters, police, paramedics and military personnel – you will find the rewind technique and associated skills hugely helpful. Course requirements Guided imagery, relaxation and visualisation are an integral component of the Rewind Technique – if you don’t already have experience in using these skills therapeutically with others you must complete our Guided Imagery and Visualisation for Therapeutic Change workshop before attending this course (this is always run the day before our rewind technique training). This is to ensure you get the most out of this 2-day course and also have the necessary skills for practising the rewind technique safely and effectively. You would also find it useful to attend the Therapeutic Power of Language workshop beforehand if you can. All 3 workshops count towards Part 1 of the HG Diploma. Ros Townsend’s live online training Trauma: Patterns of the past is also useful for anyone working with or supporting someone suffering from unresolved trauma, or who would like to understand their own experiences of trauma better. She also runs a workshop on working with Complex Trauma. *About the Rewind Technique The Rewind Technique originated from one developed by Richard Bandler, one of the founders of NLP, when it was called the Visual/Kinaesthetic Dissociation protocol. A variant of this was developed by Dr David Muss, who called it the Rewind Technique. The version of the Rewind Technique you will learn on this 2-day course was refined by Joe Griffin and Ivan Tyrrell, co-founders of the human givens approach, to make it as reliably effective and safe as is possible by aligning the method with their insights into how trauma and phobias are processed in the brain. HG Therapists now follow a specific Rewind Protocol which follows the essential steps of the process that Griffin and Tyrrell set out. Course format This intense 2-day training proceeds through a blend of talks, live demonstrations, skill-developing exercises, practice sessions (under careful guidance) and deconstruction of filmed examples of the technique being used, including one with a severely traumatised young woman. There is also plenty of opportunity for networking and discussion during the breaks. The course was previously entitled: The fast phobia and trauma (PTSD) cure – a 2-day workshop in the rewind technique This course has been independently accredited by the internationally recognised CPD Standards Office for 12 hours of CPD training. On completion of this training you’ll receive CPD certificates from the College and the CPD Standards Office.

Master advanced Excel skills and boost your career with our Microsoft Excel Advanced Diploma Course. Gain proficiency in data analysis, understand advanced features, and develop practical expertise.

Embark on a transformative journey in the Middle Manager Management course. This program is designed to equip aspiring and current middle managers with the skills and knowledge required to excel in their roles. Through a series of comprehensive modules, you will delve into the intricacies of middle management, corporate responsibilities, leadership, decision-making, and addressing poor management practices. Learn the art of complaint mitigation and discover the power of grooming, coaching, and mentoring middle managers to enhance organizational effectiveness. Learning Outcomes: Gain a solid understanding of the role of middle managers and their significance in organizational success. Explore the corporate responsibilities and ethical considerations that guide middle management. Develop leadership skills crucial for effective decision-making and team motivation. Recognize the signs and consequences of poor management and learn strategies for improvement. Master the art of mitigating complaints to maintain a productive work environment. Acquire techniques for grooming, coaching, and mentoring middle managers for professional growth. Enhance your communication and interpersonal skills essential for middle management roles. Develop the ability to adapt to evolving organizational dynamics and challenges. Why buy this Middle Manager Management?  Unlimited access to the course for forever Digital Certificate, Transcript, student ID all included in the price Absolutely no hidden fees Directly receive CPD accredited qualifications after course completion Receive one to one assistance on every weekday from professionals Immediately receive the PDF certificate after passing Receive the original copies of your certificate and transcript on the next working day Easily learn the skills and knowledge from the comfort of your home Certification After studying the course materials of the Middle Manager Management you will be able to take the MCQ test that will assess your knowledge. After successfully passing the test you will be able to claim the pdf certificate for £5.99. Original Hard Copy certificates need to be ordered at an additional cost of £9.60. Who is this course for? This Middle Manager Management course is ideal for Aspiring middle managers looking to advance their careers. Current middle managers seeking to enhance their management and leadership skills. HR professionals responsible for middle management development. Organizations committed to fostering effective middle management practices. Prerequisites This Middle Manager Management was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Career path Middle Manager: £35,000 - £60,000 per year. Senior Middle Manager or Department Head: £50,000 - £90,000 per year. Management Consultant: £40,000 - £80,000 per year. Human Resources Manager specializing in Middle Management: £40,000 - £70,000 per year. Leadership Trainer: £45,000 - £80,000 per year. Course Curriculum Module 01: Middle Managers and Management An Introduction Middle Managers and Management An Introduction 00:09:00 Module 02: Corporate Responsibilities of Middle Manager Corporate Responsibilities of Middle Manager 00:12:00 Module 03: Middle Manager as Leader and Decision Maker Middle Manager as Leader and Decision Maker 00:16:00 Module 04: Signs of Poor Management Signs of Poor Management 00:13:00 Module 05: Complain Mitigation Complain Mitigation 00:13:00 Module 06: Grooming, Coaching and Mentoring Middle Managers Grooming, Coaching and Mentoring Middle Managers 00:10:00

Equip managers and supervisors with the knowledge and skills to address and prevent sexual harassment in the workplace. Delve into the various aspects of sexual harassment, from its definition to recognizing and effectively managing instances. Learn about policies, procedures, and strategies that promote a safe and respectful work environment. Learning Outcomes: Understand the concept and implications of sexual harassment. Differentiate between various types of sexual harassment. Recognize signs and behaviors indicative of sexual harassment. Explore workplace policies and procedures for handling such cases. Develop effective strategies to address and prevent sexual harassment. Learn how to foster a respectful and inclusive work culture. Acquire communication skills to address incidents with sensitivity. Gain insights into legal and ethical considerations surrounding sexual harassment. Why buy this Sexual Harassment in the Workplace Training for Managers and Supervisors (SHWT)?  Unlimited access to the course for forever Digital Certificate, Transcript, student ID all included in the price Absolutely no hidden fees Directly receive CPD accredited qualifications after course completion Receive one to one assistance on every weekday from professionals Immediately receive the PDF certificate after passing Receive the original copies of your certificate and transcript on the next working day Easily learn the skills and knowledge from the comfort of your home Certification After studying the course materials of the Sexual Harassment in the Workplace Training for Managers and Supervisors (SHWT) you will be able to take the MCQ test that will assess your knowledge. After successfully passing the test you will be able to claim the pdf certificate for £5.99. Original Hard Copy certificates need to be ordered at an additional cost of £9.60. Who is this course for? This Sexual Harassment in the Workplace Training for Managers and Supervisors (SHWT) course is ideal for Managers and supervisors responsible for employee well-being. HR professionals seeking to strengthen workplace policies. Business owners aiming to cultivate a harassment-free environment. Individuals interested in promoting safe and inclusive workplaces. Prerequisites This Sexual Harassment in the Workplace Training for Managers and Supervisors (SHWT) was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Career path Human Resources Manager - Average Earnings: £30,000 - £60,000 per year. Employee Relations Specialist - Average Earnings: £25,000 - £50,000 per year. Training and Development Manager - Average Earnings: £30,000 - £60,000 per year. Workplace Diversity and Inclusion Officer - Earnings Vary Depending on Organization. Legal Consultant Specializing in Employment Law - Earnings Vary Depending on Client Base. Course Curriculum Module 01: What is Sexual Harassment? What is Sexual Harassment? 00:12:00 Module 02: Types of Sexual Harassment Types of Sexual Harassment 00:12:00 Module 03: Recognising Sexual Harassment in the Workplace Recognising Sexual Harassment in the Workplace 00:12:00 Module 04: Policies and Procedures Policies and Procedures 00:11:00 Module 05: How to Deal with Sexual Harassment in the Workplace? How to Deal with Sexual Harassment in the Workplace? 00:14:00 Assignment Assignment - Sexual Harassment in the Workplace Training for Managers and Supervisors (SHWT) 00:00:00

Building High-Performance Teams: Virtual In-House Training This course pulls together the most current and popular theories and writings on this complex topic and presents this amalgamated view in a highly interactive workshop and activity-based approach. Students will understand and have the skills required to build and participate in high-performance project teams and will possess the insight to proactively affect change within their respective organizations by guiding the existing culture to one that promotes high performance. What you will Learn At the end of this program, you will be able to: Define a team and describe the optimum team size for effective performance Describe characteristics and guiding behaviors of high-performance teams Describe the major elements of each development stage in two distinct models Recognize cultural barriers in achieving high performance List the attributes of a high-performing corporate culture Assess your own corporate culture Discuss corporate leadership as a factor in building high-performance project teams Describe the three A's of selecting team members State three leadership responsibilities Describe leadership responsibilities, styles, and roles List and describe the eight components of the team charter model for building high-performance teams Foundation Concepts The Nature of Teams Characteristics of High-Performance Teams Understanding Team Development Stages of Team Development - Model 1 Stages of Team Development - Model 2 Designing a High-Performance Culture Corporate Cultures Corporate Leadership Establishing the Attributes of High Performance Choosing the Right People Team Effectiveness Team Leadership The Team Charter Model

Whether you're crafting a compelling blog, scrutinising a screenplay, or decoding ad scripts, you need to deploy and perceive language with the target audience at heart. The A-Level English Language course, designed for the self-paced scholar, empowers you to refine your command of a tongue embraced by 390 million worldwide 🌍. Delve into a comprehensive array of texts and augment your critical understanding with our bespoke course.  If your aspirations hinge on written and spoken communication, English Language is a powerful asset to bolster your career trajectory. A-Levels are not just qualifications; they're a testament to your proficiency, a beacon recognised and respected by universities and employers across the UK. An A-Level is not just a line on your CV, but a symbol of academic rigour, enhancing your career prospects and unlocking new horizons 🌈. This distance learning course, sculpted to the most current specifications, is your stepping stone to success. It kicks off with a lucid induction and assignments intricately designed to help you accumulate the skills and knowledge needed for the final hurdle - the exam 🎯. What's in it for you?  A fresh, invigorating course tailored to the latest specifications with dynamic content 📚 The fast track option (exams due 2022) for those eager to accelerate their progress ⏩ A complimentary e-textbook to facilitate your learning 📖 Access to a consortium of partnership exam centres (guaranteed exam venue) 📍 Limitless tutor support - from drafting a study plan to unwavering support throughout your journey 📈 An exam pass guarantee - If at first you don't succeed, we'll steer you towards your next attempt 🥇 Awarding Body: AQA Our course code: X903 Qualification code: 7702 AQA qualifications are not only internationally acclaimed and taught in 30 countries but also highly sought after by employers and universities. They enable students to springboard into the next stage of their lives. Our suite of AQA qualifications caters to a diverse range of abilities and includes GCSEs, IGCSEs, and A-levels 🏅. ⏳ Study Hours Anticipate committing between 250 and 300 hours to this comprehensive course. This estimate includes time dedicated to the completion of assignments.  💻 Study Method Our digital learning platform offers an engaging, dynamic, and flexible learning experience. Should you prefer hard copies, all learning materials can be printed at your convenience. We utilise a multitude of media to deliver this course, including videos, quizzes, and interactive exercises.  📚 Course Duration Embark on your learning voyage today. Benefit from unlimited support from our dedicated tutors for up to 24 months from your enrolment date. ✍️ Assessment Examinations are scheduled from Summer 2022. Your course will culminate in two standard written exams: Official Examinations: 2 hours 30 minutes, accounting for 40% of your total grade 2 hours 30 minutes, accounting for 40% of your total grade 1 coursework task, contributing 20% of your total grade (refer to NEA section) We will provide a guaranteed exam location at one of our many centres nationwide for your convenience. Assignments During your course journey, you will be asked to complete: • 10 assignments These are non-graded tasks designed to provide opportunities for tutor feedback and to gauge your progress. Non-exam Assessment (NEA): • 1 coursework task, contributing 20% of your total grade This coursework, part of the A-level assessment, is completed during your learning journey and forwarded to your exam centre for marking. More details will be provided upon enrolment. 🎓 Course Outcomes Upon successful completion, you will be awarded an A-Level in English Language by AQA (7702). This syllabus is specifically selected for its compatibility with distance learning. Your certification will be identical to those conferred by traditional schools, colleges, and universities. 📚 Additional Information Difficulty - Level 3 Pre-requisites - A strong recommendation of prior study in English language to GCSE level or equivalent. UCAS Points - 56 📘 Course Content Methods of language analysisPhonetics, phonology and prosodicsGraphologyLexis and semanticsGrammar, including morphologyPragmaticsDiscourse Textual variations and representationsThe textual range (various subjects, writers, audiences)Functions of the textsIdentity and representationsHow audiences are addressed and positionedStructure and organisation of the texts Children’s language developmentPhonological, pragmatic, lexical, semantic and grammatical developmentThe development of written languageThe functions of children’s languageTheories and research about language development Diversity and changeLanguage in its wider social, geographical and temporal contextsProcesses of language changeSocial attitudes to language diversity and change Language discoursesStudying texts that convey attitudes to language diversity and changeMethods of conveying views and opinions about language issues: representations, identities and positioning.Connecting to discourses about languageThe directed writing task Language Investigation (NEA)Choosing an investigation focusCarrying out the investigation (including ethics, record keeping and referencing)Organising and analysing the data and interpretation of findingsConcluding your investigation Original writing (NEA)An overview of the assessment and marking criteria, including organising and referencing workChoosing your area of original writing (Power of persuasion, storytelling & power of information)Choosing and analysing style modelsProducing a reflective commentary Preparing for the A Level examinationsRevision TipsExam TechniquesPreparing for Paper 1Preparing for Paper 2 Delve into the subtleties and nuances of the English language, studying everything from phonetics to pragmatics, grammar to graphology, and language development to discourses. This course will provide you with a comprehensive understanding of the richness and diversity of English, equipping you with the knowledge and skills needed for your A-Level examination.

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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