Employee Assistance Programme Training
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
Join Dr Andrew Morrice for a deep dive into what the latest mind-body research tells us about the impact of sleep, the microbiome, nutrition, culinary practices and more on our mental and physical health, and recovery … Length: 1 day (9.30am - 4.00pm) A brilliant framework to understand the neurobiology of our needs and how to manage stressDR ALLY JAFFEE, NHS DOCTOR Why take this course Sleep and sound nutrition are widely recognised to be essential to mental health – this day gives you an opportunity to learn about these two areas in depth, including the role of the Microbiome. A greater understanding of these two areas can be vital in freeing ourselves from the ‘mind-only mindset’ to help us quickly and effectively resolve many of our difficulties in life. Sleep has always been integral to the human givens approach and this course is a chance to catch up on recent advances in understanding and evidence as to which approaches best help with poor sleep. We will explore how sleep allows for the physical recuperation, learning and emotional regulation that are key to improving many mental health problems. The role of food and the microbiome in mental health is seldom part of managing the immediate challenges we face, yet is so important in preventing difficulties, or maintaining recovery, that it is an area in which we can benefit from feeling greater confidence when guiding and advising our clients (or ourselves!). Throughout the day, tutor and GP Andrew Morrice draws on the latest research and his decades of experience managing the complex combination of mental and physical health problems in General Practice (20 of those years, using the Human Givens model), to take us on a deep dive into two of the key interfaces between mind and body: sleep and food, and their effects on our health. Andrew is a most inspiring teacher who is passionate about his subject. Furthermore, his experience as a doctor was invaluable...PSYCHOTHERAPIST / COUNSELLOR What will you learn The structure of sleep – and the functions of the different stages of sleep, including Non-REM and Slow Wave/Deep sleep The fundamental conditions required to promote healthy sleep The challenges of assessing sleep properly both for ourselves and others The complex relationships between sleep disturbances and depression, anxiety, pain syndromes and fatigue states, plus Simple organising ideas for navigating all this complexity What we can do to help resolve sleep difficulties so that we can wake feeling refreshed and emotionally prepared for the next day The fundamental science of the Microbiome – and its links to inflammation, mental health and physical health The eating patterns that worsen or help in mental and emotional health How and why processed foods undermine and confuse our innate guidance systems An understanding of the many other factors impinging on our ability to ‘forage’ well in the modern ‘food environment’ The basis on which foods or eating can become addictive, and how this can point to ways to address these difficulties Why we should consider the implications of the fasting state for our work How Human Givens tools can help clarify many of the confusions around food How to spot diet cults, tribes, and misleading claims Eating patterns we can confidently recommend to support health and wellbeing A review of how depression can be seen as a mind-body state rather than a ‘mental health disorder’ You will also have time to ask our expert tutor questions and benefit from group discussions Course Programme The ‘The Mind-Body Connection in depth: Movement, Emotion and Calm’ course starts at 9.30am and runs until 4.00pm. From 8.30am Registration (Tea and coffee served until 9.25am) 9.30am Microbiome and Diet – Finding our Food: how did this get so complicated and confusing? 10.45am Discussion over tea/coffee 11.15am Understanding Processing, Addiction and Tribalism 12.45pm Lunch (included) 1.30pm Getting a good night's sleep 2.45pm Discussion over tea/coffee 3.00pm Sleep, depression and inflammation 4.00pm Day ends Who is this course suitable for? The Mind-Body Connection In Depth series is open to anyone interested in deepening their understanding of mental and physical health. If you previously attended Andrew Morrice’s Mind-Body Connection course, and would like to spend more time on practical applications, the microbiome, the interface between diet and mental health and to thoroughly review the topic of sleep – this course is for you. Please note: you don’t need to have attended the previous Mind-Body Connection course to come on this one, or its sister course ‘Movement, Emotion and Calm’. This course has been independently accredited by the internationally recognised CPD Standards Office for 6 hours of CPD training. On completion of this training you’ll receive CPD certificates from the College and the CPD Standards Office.
Course Information Designed to develop personal proficiency in audit planning, execution and reporting, this course is meticulously crafted to refine essential audit skill sets. Through immersive scenarios focused on on-site audit conduct (with an alternative Remote Auditing Course available), participants will engage deeply in the audit process. Extending Expertise: Applicable across all audit types, this course builds upon and enriches the foundational concepts taught in RQA's suite of research quality assurance courses. From 'Research Quality Assurance for Good Laboratory Practice' to 'Good Clinical Practice Auditing – Principles and Practice' and 'Good Manufacturing Practice for Investigational Medicinal Products,' this programme extends the scope of learning. Relevance and Value: Relevant to any area of regulated research and development, this course shines particularly in contexts mandating a quality system for audit. Participants with prior audit experience will gain maximum value from this course. Key Benefits: Enrich your skill set to: Navigate audit processes encompassing planning, execution, reporting, and follow-up Embrace a personalised approach fostering positive audit outcomes Analyse evidence and present cohesive audit findings Recognise the pivotal role of audits in driving continual improvement. Interactive Learning: Structured to foster dynamic engagement, this course encourages delegates to: Engage in discussions, idea development, and problem-solving Exchange invaluable information and experiences. Hands-On Experience: A highlight of this course is the series of practical workshops, where delegates work in small syndicate groups, applying the acquired skills from lectures into real-world scenarios. Tutors Tutors will be comprised of (click the photos for biographies): Andrew Waddell Founder Director, Tower Mains Ltd Rosemary Ichaba Senior QA Associate, Tower Mains Ltd Cate Ovington Director, The Knowlogy Group Ltd Jean McWilliam Associate Director, Alexion View pop up Programme Please note timings may be subject to alteration. Day 1 08:45 Registration 09:00 Welcome and Course Objectives 09:10 What is 'Audit'? Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements. 09:30 Audits and their Purpose The concepts of quality assurance, quality control, quality management and audit are discussed. 10:30 Break 10:45 Audit Planning The requirements for an effective audit programme and individual audit plans. 11:30 Workshop 1 - Getting the Audit Started Planning for the audit. 12:25 Workshop 1 - Feedback 12:45 Lunch 13:30 Workshop 2 - Getting the Audit Started Arranging the opening meeting. 13:50 Workshop 2 - Feedback Audit initiation. Review and discussion of the role of the opening meeting. 14:25 Auditing Techniques (1) - Data and Documentation Techniques for the conduct of data and report audits are investigated. 14:55 Break 15:10 Workshop 3 - Data and Documentation Audit Conducting an audit of a data package and supporting documentation. 17:15 Close of Day Day 2 09:00 Auditing Techniques (2) - The People Questioning techniques which get the required information from the auditee. 09:45 Live Audit Role Play Auditor and auditee behaviours are explored and strategies developed for successful audit interactions. 10:15 Break 10:35 Audit Closing Meeting An exploration of audit closing meetings. 11:00 Workshop 4 - Audit Observations and Preparing for the Closing Meeting Reviewing and categorising your observations and getting ready to present your case. 11:45 Workshop 4 - Feedback 12:30 Audit Reports The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed. 13:00 Lunch 13:45 Workshop 5 - Audit Reports and Follow-up Mechanisms for promoting effective corrective and preventive action. Critical review of an audit report example. 14:30 Workshop 5 - Feedback 14:55 Corrective and Preventive Action and Follow-up The auditor's role in monitoring responses to audit and the corrective and preventive actions promised is explored. 15:20 Panel Session An opportunity to get answers to outstanding questions. 15:30 Close of Course Extra Information Course material Course material will be available in PDF format for delegates attending this course. 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. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. CPD Points 14 Points Development Level Develop
Join our one-day professional training course in Manual Lymphatic Drainage (MLD), a unique massage technique known for its detoxifying, calming, and pain-relieving benefits, in addition to boosting the immune system. Despite its profound effects, it's straightforward to master with guidance from our skilled instructors. The massage technique is particularly useful for the treatment of lymphoedema and swelling that is often seen in response to cancer treatments such as radiotherapy. It's specialised pumping technique can be used to prevent or treat lymphoedema and improve lymph drainage. Join our professional one-day Manual Lymphatic Drainage (MLD) Practitioner course to master a massage technique renowned for its therapeutic benefits, including detoxification, relaxation, pain relief, and immune support. With expert tutors, learn this effective, gentle method to address a range of conditions, from lymphoedema to stress. Our focused, small-class setting ensures personalised instruction, making our training center a top choice in the UK for developing advanced skills in MLD. Why Choose Our Training? Immediate Impact:Learn treatments that offer visible results from the first session. High Demand Skills: Master a technique with growing client demand, ensuring your services are always in demand. Expert Instructors: Benefit from hands-on training by industry leaders with in-depth experience in aesthetic medicine. Course prerequisites This course is suitable for: No previous experience is necessary NVQ Level 3 in beauty therapy, ITEC or HND is desirable Qualifications in sports massage or full body massage is desirable Course structure You are required to complete 20 hours of theory study via our accessible e-learning portal and 4 practical hours onsite. All courses are kept intimate with a maximum of 6 learners to a class. Areas covered within the course: Explore the anatomy and roles of the lymphatic system, focusing on its components such as lymphocytes, tissues, vessels, nodes, ducts, capillaries, and the spleen, to understand its crucial role in immunity and fluid balance. Key lymph nodes located throughout the body. Overview of the blood vessels of head and neck Relationship between blood and lymph History of Manual Lymphatic Drainage Massage Contraindication to Manual Lymphatic Draining Massage treatment Guidance on manual lymphatic drainage massage techniques, detailing the four foundational strokes and other methods. These techniques are designed to be versatile, allowing for application across any body part and integration into existing massage practices
The 2-day Coaching and Mentoring for Managers course is designed for organisations that want their managers and team leaders to apply practical coaching and mentoring skills in everyday work situations in order to develop the performance of those they are responsible for, as well as improving communication within the business. Previous attendees have included chief executives, general managers, and HR managers, right through to production line supervisors and office staff. In fact, anybody that has to work as part of a team and relies on other people's efforts will benefit from this programme. Course Syllabus The syllabus of the Coaching and Mentoring for Managers course is comprised of four modules, covering the following: Module One Introduction to Coaching and Mentoring Exploding the myths surrounding coaching Benefits of coaching and mentoring The role of a coach and mentor How to avoid everyday interference that takes your time away from coaching people to achieve results How motivation works The difference between mentoring, coaching, directing, supporting & delegating, and learning when it is necessary to apply them Why coaching is an action orientated partnership purely focused on measurable results Coaching and mentoring outcomes Module Two Managing a Coaching Session The most important skills of a business coach The key characteristics of a good coach How to ask powerful coaching questions Opportunity to role-play using the STAR/GROW model Module Three Mentoring in Action Mentoring suggestions The first meeting Between first and second meetings The second meeting The Experiential learning cycle Model discussions Frequent questions asked by Mentors Duration of mentoring End of relationships Module Four Putting Learning into Practice Building a bank of great coaching questions Demonstration of what has been taught in a live coaching/mentoring meeting Individual feedback from a professional coach Creating SMART action plans Getting started as a work coach/mentor Group review and feedback on new learning Action steps for new coaches Scheduled Courses Unfortunately this course is not one that is currently scheduled as an open course, and is only available on an in-house basis. Please contact us for more information.
Immerse Medical are experienced at teaching first aid to young people within the educational sector. We have designed this workshop style programme specifically for those in KS3/4. The sessions are fun, engaging and focus on fundamental life saving skills. Using interactive gamification, students gain hands on experience, which they will draw upon in real life medical emergencies. These sessions are perfect as part of phase 2 of National Citizenship Service (NCS) and Duke of Edinburgh (DofE) Awards. Key points Meets national curriculum secondary education guidelines– We’ve designed this programme to exceed the requirements of the 2020 guidelines. Training by doctors, nurses and paramedics – We have years of experience working on the front line of emergency medicine; giving us real world knowledge and skills in managing injured or unwell people. Latest equipment & technology – We utilise technology enhanced learning to provide a realistic opportunity to practice fundamental life saving skills in a safe environment. More than first aid – While participating in this workshop young people will also develop their ability to work as part of team, communicate effectively and think critically in high pressure situations leading to an overall increase in personal confidence. Check out the skills included in the videos below. First Aid Courses For Young People Programmes and sessions for young people focusing on how to keep each other safe and what to do if something goes wrong. Sessions are designed with age and national curriculum in mind, from 1 hour tasters to sessions for large groups, perfect as part of NCS and Duke of Edinburgh programmes. Our training for young people is fun, engaging and focuses on fundamental life saving skills. All courses can be delivered at our training centre in Poole, Dorset or we can deliver on-site across Bournemouth, Poole, Dorset, Hampshire and the South of England.
Course Information Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines. How is this course run? Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys. What will I learn? A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments Solid grounding in quality assurance activities aligned with regulatory standards Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues Clarity on the roles and responsibilities inherent to clinical trials auditing Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents A nuanced understanding of regulatory inspectors' activities Expanded professional networks to propel your auditing career forward. Benefits include: A clear understanding of the role of the auditor under Good Clinical Practice improved audits Improved Good Clinical Practice compliance for your clinical trials. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of Good Clinical Practice. Tutors Tutors will be comprised of (click the photos for biographies): Rosemarie Corrigan EVP Global Quality, Worldwide Clinical Trials Cathy Dove Director and Owner, Dove Quality Solutions Julie Kelly Associate Director, Clinical Quality Assurance, Corcept Therapeutics Susana Tavares Director of Research Quality Assurance, - Programme Please note timings may be subject to alteration. Day 1 12:30 Registration 13:00 Welcome and Objectives for the first day of the course 13:30 Laying the Foundations Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 14:30 Break 15:00 Patient Protection Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise. 16:05 Workshop 1 - Case Study on Informed Consent 16:45 End of Day Questions and Answers 17:00 Close of Day Day 2 08:50 Questions and Answers from Day 1 09:00 Effective Site Audits The procedures involved in selecting and setting up audits at investigator sites. 09:40 Workshop 1 - Planning the Effective Audit 10:30 Break 10:45 Source Data Verification The need for and purpose of verifying data. 11:25 Workshop 2 - Source Data Verification 12:30 Lunch 13:30 IMP Management The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction. 14:15 Critical Document Audits The conduct of other study specific audits including protocols, databases and reports. 15:00 Break 15:15 Non-compliance Determining the acceptability of data. 16:00 Fraud - Fact or Fiction? How to identify fraud and its consequences 16:45 End of Day Questions and Answers 17:00 Close of Day Day 3 08:50 Questions and Answers from Days 1 and 2 09:00 Auditing Third Parties A review of audits of contract research organisations. 10:00 System Audits The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 10:45 Break 11:00 Workshop 3 - Process Mapping 11:45 Effective Audits Where theory meets reality. 12:30 Lunch 13:20 Audit Reports - Closing the Loop An examination of the processes which follow the evidence gathering phase of the audit. 14:20 Workshop 4 - Audit Reports Audit reports, corrective and preventive action. 15:00 Break 15:10 Regulatory Inspection Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 15:55 Final Questions and Answers 16:10 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. 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. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote 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 17 Points Development Level Develop