150 Clinical Practitioner courses

Course Information Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. Is this course for you? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. This course will give you: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) Insight into the seamless integration of GCLP within clinical programmes (GCP) Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Access to a seasoned panel of speakers with extensive expertise A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. Engage in: Lively discussions to foster ideas Problem-solving sessions targeting specific challenges Detailed exploration of specific aspects within the realms of GCP and GCLP. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Louise Handy Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 Safety and Ethical Consideration Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 Break 10:55 Organisation and Personnel Responsibilities within GCP and the Laboratory The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 Staff Training and Training Records Personnel records of training and competency assessments are discussed. 11:45 Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 Lunch 13:15 Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 Workshop 1 - Feedback 14:15 Computer Systems Validation Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 Trial Protocols, Analytical Plans During this session we examine the purpose, content, control and change of these important documents. 15:30 Break 15:45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 Workshop 2 - Feedback 17:00 Close of Day Day 2 09:00 Conduct of the Work and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 Deviation Management The expectations around deviations and CAPA are discussed. 10:15 Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. 10:45 Break 11:00 Workshop 3 - Feedback 11:30 Source Data, Data Integrity, Records and Reports The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. 12:45 Lunch 13:30 Workshop 4 - Feedback 14:00 Quality Audit The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 Risk Management How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 Break 15:30 Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 Panel Session This panel session will address any outstanding issues raised by the delegates. 16:15 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

Course Description Training will cover detailed anatomy and physiology of the lymphatic and associated vascular system, pathology of lymphoedema and chronic oedema and the different stages and types of lymphoedema. Please note: Your training will be delivered through a blended learning format. With our blended learning format, you will have the opportunity to complete the theoretical components of your training at your own pace. In addition to the online learning, we offer clinical skills training on scheduled workshop dates. This hands-on training will allow you to put your theoretical knowledge into practice and develop the necessary skills to excel in your field. Our experienced instructors will guide you through each step of the training, ensuring that you are fully prepared and confident in your abilities. Once you have completed your clinical skills training, you will receive your certification, validating your skills and knowledge. Please note price includes VAT Our Comprehensive Lymphoedema Training Course  Course Summary Join us on our blended learning training programme especially designed for certified healthcare professionals working within clinical settings.   By the end of the course, you will have a thorough understanding of the anatomy and physiology of the lymphatic system, enabling you to holistically assess and diagnose a patient with lymphoedema. You will be able to design and implement an appropriate research and evidence based individualised management strategy selecting from a range of therapies and new innovations. You will be competent in the field of Decongestive Lymphatic Therapy including Multi Component Bandaging (MCB) and the latest knowledge and research in Fluoroscopy Guided - Manual Lymphatic Drainage (FG-MLD®) Entry Requirements This training is suitable for: All certified healthcare professionals. Such as Medics, Registered General Nurses, Physiotherapists, Radiographers, Occupational therapists, Osteopaths and Chiropractors Learning Format Your course is made up of a blended learning format meaning your content and modules will be taught via live interactive webinars, through self-guided independent study and face to face clinical skills workshops. So, whether you're learning style is social, solitary, visual, kinesthetic, auditory or a combination we have a learning style to help you get the best out of the course. We hope that you make the most out of the tools that are available to you throughout the course but don't worry if you are not the most "tech-savvy", we have real people on hand to help you every step of the way. Assessment Criteria All students will undergo a series of course specific formative & summative assessments. Throughout the course you will be assessed through observation of practical tasks, written assessments, assignments, research and online tests. Course Contents You will gain knowledge, skills and techniques in: Compression Exercise Skincare & Wound Healing Garments Multi-Component Bandaging Assessment & Treatment of Oedema Anatomy & Pathways of the Upper & Lower Limb FG-MLD® Technique Tissue Dielectric Constant Head & Neck, Midline & Genital Oedema.   Training will also cover innovations and consideration for clinical practice. Course Inclusions As part of your training pack, LTA will provide all training support materials required to undertake the course.   Such as but not limited to: Corporate Sponsored Bandaging Pack LymphBalls™ Latest LTA Research & Development articles Lymphoedema supporting literature Access to in-house LTA training & demonstration videos Learning management platform (CANVAS) profile & course content Snacks & Refreshments throughout your practical skills workshops Dedicated support from the LTA training team Course Certification The benefits of an LTA certification means you can; Display FG-MLD® Certified and LTA Cert. logo on your marketing material Write LTA Cert. after your name Wear your qualification badge Practice MLD to further enhance outcomes Use an innovative technique and ensure effective treatment programmes Receive training and support from Jane Wigg & Team Access the latest developments in Lymphoedema care Have access to a private FG-MLD® Therapist FB Page Recertification To maintain your LTA Therapist Certification, a 2-day recertification is required after 12 months after your initial training, and you will be required to attend a 1-day recertification every 2 years thereafter to maintain your certification of practice.

GCP Good Clinical Practice

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

These topics are available as individual sessions or we can deliver all three as a full day’s training for Registered Practitioners. Facilitated by registered clinicians with extensive experience.

Course Information Join us for a two-day immersive course crafted to equip participants with an in-depth understanding of remote audit methodologies. Delve into the nuances between remote and face-to-face audits, dissecting their respective strengths and limitations. Through practical scenarios tailored for remote audit conduct, this course stands as an essential counterpart to our on-site audits course The Auditing Course. Who Should Attend: Applicable across various domains of regulated research and development, this course proves invaluable in contexts requiring a quality system for audit. Participants with firsthand audit experience stand to gain the most benefit from this programme. Expanding on Previous Learning: This course extends its relevance to all forms of audits and further amplifies concepts explored in RQA's suite of research quality assurance courses, including: 'Research Quality Assurance for Good Laboratory Practice,' 'Good Clinical Practice Auditing – Principles and Practice,' and 'Good Manufacturing Practice for Investigational Medicinal Products.' Benefits include improved: Understand the processes of planning, conducting, reporting and follow-up of audits Recognising the importance of personal approach in developing positive audit outcomes Ability to analyse evidence and present logical audit findings Appreciate the importance of audit in continuing improvement. This course is structured to encourage delegates to: Discuss and develop ideas Solve problems Exchange information. 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 Programme Please note timings may be subject to alteration. Day 1 09:00 Course Registration 09:15 Welcome and Introductions 09:35 Introduction to Audits 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. 10:05 Introduction to Remote Audits Presentation to introduce the major differences between face-to-face audits and remote audits. The major elements of audits will be examined to determine where there may be differences. 10:30 Break 10:45 Workshop 1 - Remote Audits This workshop will examine participants experience or understanding of the differences between face-to-face and remote audits. 11:15 Workshop 1 - Feedback 11:35 Audit Preparation The essential steps in preparation for audits will be discussed with emphasis on remote audits. 12:05 Workshop 2 - Remote Audit Preparation Factors relating to the preparation for remote audits will be considered in discussion groups. 12:35 Workshop 2 - Feedback 12:50 Lunch 13:30 Audit Logistics Preparation for the audit includes many arrangements other than the audit content. 14:00 Workshop 3 - Audit Logistics Delegates will discuss some of the issues that may occur during the set up and conduct of remote audits and how to resolve them. 14:30 Workshop 3 - Feedback 14:45 Break 15:00 The Opening Meeting Presentation regarding the importance and content of the opening meeting. 15:20 Workshop 4 - Opening Meeting Delegates will consider the practicalities of arranging and conducting an opening meeting. 15:45 Workshop 4 - Feedback 16:10 Audit Conduct Tools Practical advice on preparation of some of the tools that will be valuable in the conduct of audits. 16:40 Questions and Answers An overview of the first day and a chance to ask questions 17:00 Close of Day Day 2 09:00 Reflections on Day 1 Recap on the topics covered and a chance for delegates to raise points. 09:15 Gathering Evidence Presentation on challenges of gathering evidence and conducting interviews during remote audits. 09:45 Workshop 5 - Remote Interviews Scenarios of different remote interviews will be played and delegates assess the strengths and weaknesses of each approach. 10:15 Break 10:30 Creating Audit Findings Ideas regarding how to create good audit findings will be discussed during this short presentation. 10:50 Workshop 6 - Creating Audit Findings Delegates will be provided with examples of evidence from an audit. They will discuss these and create their audit findings for presentation at the closing meeting. 11:35 The Closing Meeting The content and conduct of the closing meeting will be discussed. 11:55 Workshop 7(a) - Preparing for the Closing Meeting The findings from workshop 6 will be reviewed and a Lead Auditor selected to provide feedback in workshop 7(b) 12:15 Workshop 7(b) - The Closing Meeting The Lead Auditor from each group will hold a meeting to present the results (role play). 12:45 Lunch 13:30 The Audit Report This presentation will cover not only the essential contents of the audit report but also how to write the report in a manner that will generate the most positive reaction. 14:00 Workshop 8 - The Audit Report Delegates will be provided with an audit report from an audit conducted remotely and will conduct a peer review of the report in their breakout groups. 15:00 Workshop 8 - Feedback 15:20 Break 15:35 Audit Closure Presentation on how to conclude the audit with reference to post-audit activities. 15:55 Open Forum 16:30 Close of Course Extra Information 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.  

The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.

Laser, Facial and Beauty

I’ll share a case of visual hallucinations, showing how an existential-phenomenological approach helps understand their meaning and purpose. We aim to explore the lived experiences on irregular perceptions of reality with an open mind. Each Saturday includes: a live dialogue between Prof. Ernesto Spinelli and an International Existential Therapist; a moment to share your thoughts and feelings with the teachers; and a final integration facilitated by Bárbara Godoy. This series of ten dialogues set out to explore the multifaceted dimentions and complexities associated with Existential Therapies. It attempts to engage with various interpretations of insanity through the lens of patients often painful, confounding, and deeply unsettling life experiences. Hallucination- between Prof. Ernesto Spinelli and Prof. Simon du Ploc “The phenomenon of hallucination has been a subject of debate for centuries. It has been suggested that its function was one of revelation or prophesy, and those who hallucinated were often considered to have a ‘sacred’ affliction. In recent times, their function, at least in the West since the Age of Reason, has been often been reduced to primary indicators of schizophrenia and other forms of psychosis. Lumped into the ‘core phenomena’ of schizophrenia, the concern is not so much what they are, or what they mean to the client, or even their content, but their treatment and control. I will present an excerpt from my own clinical practice with a client who presented with distressing visual hallucinations. This piece of work illustrates how approaching such irregular perceptions of reality from an existential-phenomenological perspective can provide a way of understanding their meaning and purpose within a client’s lived experience. I will suggest that such an approach also enables us to take a creative position regarding wider notions of sanity and madness, a position which enables us to navigate a path between, on the one hand, the medical model which typically focusses on reduction and management of hallucinations, and on the other hand, a Laingian view of hallucination as a route to ‘hyper-sanity’. Adopting such a path may enable us to work more confidently with clients when they present with unusual or disturbing perceptions.” Prof. Simon du Ploc. Prof. Simon du Plock is Senior Research Fellow at the Metanoia Institute, London. He was Head of the Faculty of Post-Qualification and Professional Doctorates at the Institute from 2007 to 2020, in which role he directed counselling psychology and psychotherapy research doctorates jointly with Middlesex University. He is a Fellow of the Royal Society for Medicine, a Foundation Member with Senior Practitioner Status of the BPS Register of Psychologists Specialising in Psychotherapy, and a Member of the BPS Register of Applied Psychology Practice Supervisors. He has been a BPS Chartered Counselling Psychologist and UKCP Registered Psychotherapist since 1994. He has authored nearly one hundred journal papers and book chapters on existential therapy, and he has co-edited Existential Analysis, the Journal of the British Society for Existential Analysis, since 1993. He was an editor of the 2019 Wiley World Handbook of Existential Therapy. He has lectured and trained internationally, and in 2006 he was made an Honorary Member of the East European Association for Existential Therapy in recognition of his contribution to cooperation between West and East Europe in the development of existential psychotherapy. His clinical and research interests include phenomenological research methodology, clinical and research supervision, existential pedagogy, and working with issues of addiction and dependency. Prof. Ernesto Spinelli was Chair of the Society for Existential Analysis between 1993 and 1999 and is a Life Member of the Society. His writings, lectures and seminars focus on the application of existential phenomenology to the arenas of therapy, supervision, psychology, and executive coaching. He is a Fellow of the British Psychological Society (BPS) as well as an APECS accredited executive coach and coaching supervisor. In 2000, he was the Recipient of BPS Division of Counselling Psychology Award for Outstanding Contribution to the Profession. And in 2019, Ernesto received the BPS Award for Distinguished Contribution to Practice. His most recent book, Practising Existential Therapy: The Relational World 2nd edition (Sage, 2015) has been widely praised as a major contribution to the advancement of existential theory and practice. Living up to the existential dictum that life is absurd, Ernesto is also the author of an on-going series of Private Eye novels. Date and Time: Saturday 15 November from 2 pm to 3 pm – (UK time) Individual Dialogue Fee: £70 Venue: Online Zoom FULL PROGRAMME 2025: 25 January “Knots” with Prof. Ernesto Spinelli and Bárbara Godoy 22 February “Healing” with Dr. Michael Guy Thompson and Prof. Ernesto Spinelli 22 March “Difference” with Prof. Tod DuBose and Prof. Ernesto Spinelli 12 April “Polarisation” with Prof. Kirk Schneider and Prof. Ernesto Spinelli 3 May “Character” with Prof. Robert Romanyshyn and Prof. Ernesto Spinelli 21 June “Opening” with Dr. Yaqui Martinez and Prof. Ernesto Spinelli 19 July “Meaning” with Dr. Jan Resnick and Prof. Ernesto Spinelli 25 October “Invention” with Dr. Betty Cannon and Prof. Ernesto Spinelli 15 November “Hallucination” with Prof. Simon du Plock and Prof. Ernesto Spinelli 13 December “Hysteria” with Bárbara Godoy and Prof. Ernesto Spinelli Read the full programme here > Course Organised by:

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data in applications for marketing approval. The International Council for Harmonisation's guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice. In this short course we describe the ICH’s role in the harmonisation of regulations, introduce its guideline E6, and set out the principles of GCP.