"Empower educators and healthcare professionals with evidence-based teaching strategies and practical assessment methods through our 'Promoting Best Practice in Teaching and Assessing Medicines Management' course. Ensure safe and competent medication administration practices among healthcare learners. Enroll now."
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
Comprehensive Training for Aspiring Laser Aesthetic Technicians Our laser courses are meticulously designed to offer a complete understanding of laser procedures. We guide you through three levels of training - foundation, intermediate, and advanced - ensuring you are ready to start treating clients in just a few weeks. With the VTCT NVQ Level 4 Certificate in Laser, IPL (Intense Pulse Light) and Skin Rejuvenation, you'll be able to provide high-quality, safe, and effective laser hair removal treatments. This advanced qualification is perfect for beauty therapists and medical specialists who are passionate about aesthetics and want to expand their skillset. Hands-On Laser Hair Removal Training During your training, you'll learn to conduct thorough consultations, analyze hair and skin types, identify Fitzpatrick skin types, determine the number of sessions required, set machine parameters, perform patch tests, conduct full treatments, and provide aftercare advice. We deliver our training through a blend of online learning modules and in-person practical sessions. You'll be able to witness professional live treatment demonstrations and gain hands-on experience under the guidance of our expert tutors. The Laser Hair Removal Course is meticulously tailored for practitioners aspiring to expand their service offerings, or for those seeking to enhance their skills within larger clinics or hospital settings. The list includes aestheticians, beauty therapists, healthcare professions such as doctors, dentists, dental nurses and nurse prescribers.
Supervising first aid for mental health: What will you learn? You’ll be surprised by how much you enjoy this 2-day course. I always make sure the learning process is engaging, interactive and stimulating — so you won’t be bored. Most importantly, the training course gives you a fascinating insight into a subject that’s often brushed under the carpet. This is a safe space to speak. Provided you feel comfortable to do so, there’s plenty of opportunity to open up and share your own experiences. It’s a flexible course, and I’m always happy to tailor the content. If there’s an aspect of mental health or addiction you’d like to know more about, please just ask. Here’s the course content Defining mental health, and understanding the stigma surrounding it Factors which affect mental health Roles and responsibilities of a first aider Outline of advice — What to say to someone with a suspected mental health condition Listening without judgement Knowing when to contact the emergency services Identifying signs of stress, and how stress can be managed Alcohol and drug abuse — Its effects, and the consequences for someone’s work and personal life Applying a first aid action plan How to implement a positive mental health culture in the workplace Identifying signs and symptoms of depression, suicide, psychosis, anxiety, self-harm, eating disorders, PTSD, personality disorders, bipolar and schizophrenia Do bear in mind, this course can’t teach you how to diagnose and treat a mental health condition. That’s the responsibility of a healthcare professional. However, you’ll know where to signpost an individual who needs professional help. You’ll leave with the knowledge and confidence to approach, reassure and support someone when they need it most. Group sessions (min 6 people, max 16): £245 per person
This 6-hour qualification provides learners with the knowledge to recognise a range of mental health conditions, how to start a supportive conversation and when and how to signpost a person to seek appropriate professional help.
This training enables users to administer oxygen safely and effectively, for casualties with breathing difficulties. Delegates will learn how and when to administer oxygen to a casualty and the safety concerns with carrying, storing and administering it. This course is suitable for qualified First Aiders, Emergency First Aiders, dental practitioners and dental care professionals, nurses, healthcare professionals and others working in an environment where oxygen is available for casualty welfare.
Emergency Paediatric First Aid delivered by healthcare professionals - Educating through Experience
Awareness of first aid for mental health: What will you learn? You’ll be surprised by how much you enjoy the 4-hour session. I always make sure the learning process is engaging, interactive and stimulating — so you won’t be bored. Most importantly, it’s a fascinating insight into a subject that’s often brushed under the carpet. It’s a flexible course, and I’m always happy to tailor the content. If there’s an aspect of mental health or addiction you’d like to know more about, please just ask. Here’s the 4-hour course content: Defining mental health, and understanding the stigma surrounding it Factors which affect mental health Roles and responsibilities of a first aider Outline of advice — What to say (and not to say) to someone with a suspected mental health condition Listening without judgement Knowing when to contact the emergency services Identifying signs of stress, and how stress can be managed How to implement a positive mental health culture in the workplace Identifying signs and symptoms of depression, suicide, psychosis, anxiety, self-harm, eating disorders Do bear in mind, this course can’t teach you how to diagnose and treat a mental health condition. That’s the responsibility of a healthcare professional. However, you’ll know where to signpost an individual who needs professional help. You’ll leave with the knowledge and confidence to approach, reassure and support someone when they need it most.
Complementing the ‘Zones of Regulation’, or as a stand alone self regulation technique, Snappy Tappy® provides a practical and accessible method for children and young people to modify/calm the emotions they are feeling ‘in the moment’ or ‘after the event’, to help them feel LESS; • anxious • angry • fearful • frustrated • overwhelmed • shame • hurt or any other emotion which is distracting them, pre occupying them or preventing them being ‘in the green zone’ or in a balanced emotional state. Snappy Tappy® which is an adaptation of Emotional Freedom Techniques (EFT) is an evidence- based modality. It is often referred to as Tapping by practitioners and users because that is what we do. Tapping works with the body’s internal energy systems similar to Acupuncture. However, where Acupuncture uses needles, Tapping uses stimulation of the meridians using gentle finger tapping pressure, while simultaneously focussing on the current difficulty. This dual attention helps your brain process whatever might be troubling you. Snappy Tappy® training takes place over two sessions both 3-4 hours long. The initial training introduces the background to Tapping, examines other adaptations of EFT and gets you ready for your own Snappy Taps and case studies. These are then reviewed 2 months later and you’re on your way to helping children and young people with Snappy Tappy®. Your licence is valid for 1 calendar year and can be renewed following a yearly check in and CPD. Meet the trainer: Miriam is the author and creator of Snappy Tappy® and uses daily in her workplace within education. This position allows for reflection and change, and also a wealth of ideas to help you be the most effective in helping children and young people around you. This course is for all educators and healthcare professionals that work with children, including children with special needs. Get in touch for an informal chat to see how Snappy Tappy® is going to equip you to help others. snappytappyEFT@gmail.com Miriam Frier 07967 705973