Clinical skills, HCAs, Nurses, Chronic disease
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
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.
The latest mind body research gives us profound insights into the effects on mental health of 'physical' factors, including breathwork and time in Nature, new ways to improve mental and physical health, and more… This wide-ranging day will deepen your knowledge of the mind-body system and the impact ‘physical factors’ can have on our emotions, state of mind and memory – with additional ways to help people quickly and effectively… Accredited CPD: 6 hours 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 Having a deeper understanding of the latest research into the effects on mental health of ‘physical’ factors – such as movement and exercise, time in Nature, ‘breathwork’ and real-time connection with others – enables us to tailor powerful therapeutic interventions and deliver more informed psycho-education. This jam-packed day also covers the physiology of responses such as ‘freeze, fight or flight’, the effects of physical activity on emotional, mental, memory and brain health, why stress can become chronic, the many ways we can activate our innate capacity to restore calm through our breath and attention, why these relaxation techniques work and what they do for us physically. The findings you will explore on the workshop have implications for many areas of mental health, even addiction, and give us additional ways to help people resolve many difficulties quickly and effectively, as well as improve overall health. The HG approach recognises that meeting our emotional needs and using our resources well are key to good mental health – yet the impact of ‘physical’ factors on our emotions and state of mind can be just as profound. Even though our physical needs may appear obvious – a healthy diet, regular physical exercise etc – we know that most of the chronic diseases sweeping through the Western World are linked to “lifestyle”, indicating that many people are not actually meeting their physical needs in healthy balanced ways – despite the vast array of information available to them. Finding clarity about how best to meet our own physical needs can also help us maintain our capacity to help others. Throughout the day, Dr Andrew Morrice, a practising GP, draws on both 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). We will sift the sense from the nonsense, and see the fundamentals behind the buzzwords and trends, making it easier to think clearly about our own health as well as that of our patients or clients… Really insightful course with an amazing way into practical applications of the HG concepts...ALIYA DRAKE, HG THERAPIST What will you learn How the now well-known human ‘needs and resources’ relate to our evolutionary past, and physical lives The many ways physical movement affects the functioning of the mind and our emotions A deeper look into the physiology of emotional responses, such as ‘fight, flight, freeze’ and their impact on health Greater knowledge of the fundamentals of how we can find calm – and the very many ways these can be used to help people New information from the latest mind/body research that has implications for therapeutic lifestyle changes Also covered: What is ‘health’? And how do we get it? Key practices to support your own health, as well as your clients’ How to avoid the unhelpful psychology and aversive ‘pattern match’ that many of us have when it comes to ‘exercise’ Whether we can really be addicted to exercise and if so why? A deeper understanding about the role of “Green Space” in mental health Increased knowledge of the ways in which physical changes in the body contribute to emotional distress The many ways in which movement and physical activity are connected with mental health How thinking and moving, memory and place are inextricably linked Why stress becomes chronic (long-lasting) Greater clarity about the role some emotions play in creating physical ill health – and the powerful ways in which other emotional states promote health (including the key role of oxytocin) The science of the relaxation and oxytocin responses, and how these relate to many types of addiction, including smoking Organising ideas to understand how 6 different types of relaxation practice relate to each other A practical exploration of the many ways the relaxation response can be activated through breath and attention – including a new technique for dealing with panic Why some people may have come to believe that ‘the breathing’ can’t or won’t help them Summaries of the role of diet and sleep on our health – along with the factors considered today in ‘Therapeutic Lifestyle Change’ 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 What is health and how do we 'get it'? 10.45am Discussion over tea/coffee 11.15am The physiology of fear and calm 12.45pm Lunch (included) 1.30pm The physiology of rapport (and other topics) 2.45pm Discussion over tea/coffee 3.00pm Physical domains of mental health 4.00pm Day ends Who is this course suitable for? This course is open to anyone interested in mental and/or physical health If you enjoyed the original 1-day Mind-Body Connection course and would like time to explore in more detail the themes covered in the first half of that course, this new 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 ‘Food, Mood and Sleep’. 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 Our extensively proven course delves into the essential stages of process and system auditing. Gain invaluable insights and direction in auditing systems and processes, spanning across global and local organisational levels. This course will assist delegates with: A practical approach for the development and conduct of process and system audits An enhanced understanding of key system audit principles, preparation, design and conduct Increased expertise, efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Share knowledge and experiences. By the end of the course delegates will be better able to: Design and plan more effectively to achieve their process and systems audit objectives and add value to their organisation Improve the effectiveness, focus and credibility of the audit programme Understand the key system audit principles, preparation, design and conduct Develop system audit tools to ensure more effective audit conduct and outcome Create audit strategies utilising risk management principles Prepare for inspections. Tutors Tutors will be comprised of (click the photos for biographies): Allison Jack Executive Director, Bristol Myers Squibb Rocio Castellanos Director, Pfizer Ltd Guy Houben G(C)LP Auditor, Janssen Pharmaceutical Companies of Johnson & Johnson Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introductions, Expectations/Challenges/Experiences A discussion to explore the range of approaches to the conduct of systems audit. 09:30 Introducing Systems Audit What is a system? Why conduct system audits? Advantages, disadvantages and challenges. 10:20 Break 10:35 Systems Audit Design and Planning Identifying the customer, setting objectives, development of the audit plan and audit tools, plans for the audit report. 12:00 Designing System Audit Tools 12:45 Lunch 13:30 System Audit Plan - Exercise 14:00 Introduction to Case Studies The objectives of the case studies are defined and process and outputs described. 14:15 Case Studies - Session 1 A first opportunity for work on case studies. Defining objectives and scope and understanding the requirements of the audit client. 15:00 Break 15:20 Case Studies - Session 1 continued 16:30 Case Studies - Feedback 17:00 Close of Day 1 Day 2 09:00 Simple System Audit Example - Introduction The objectives of the case studies are defined and process and outputs described. 09:10 Case Studies - Session 2 - A Simple System Audit Example An example of system audit applied to a simple system. 10:30 Break 10:45 A Simple System Audit Example - Case Study Feedback 11:30 Strategy Audit programme planning. 12:15 Lunch 13:00 Case Studies - Session 3 Work on delegate's case studies. 14:30 Break 14:45 Case Studies - Session 3 - Feedback 15:15 Closing remarks 15:30 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 14 Points Development Level Develop