421 Confidence courses in Cambridge

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

The Level 3 International Foundation Diploma for Higher Education Studies (L3IFDHES) is usually a one-year pre-university qualification that provides students with an entry route to an overseas university. The L3IFDHES prepares students with the essential English language skills, key transferable study skills, cultural knowledge, and chosen specialisms that universities feel bridges the gap between high school and undergraduate study. In January 2023 we offer pathways in business and higher finance. With agreements in place with over 70 universities across the globe, students’ can progress with confidence to a higher education course for further study. Entry Requirements For entry onto the NCC Education Level 3 International Foundation Diploma for Higher Education Studies (L3IFDHES) qualification students must have successfully completed secondary school education. Students must also meet the English language entry requirements of: • IELTS minimum score of 4.5 or above OR • GCE ‘O’ Level English D7 or above Alternatively, a student can take the free NCC Education Higher English Placement Test which is administered by our Accredited Partner Centre’s.

I am able to travel to you to help you develop your partnership with your horse. I specialise in developing confidence in both horse and rider both on the flat and over fences. As a list 5 BD Dressage judge I can help you with test riding for BD Intro, Prelim and Novice tests. I can help with BE 90, 100 & Novice tests. As I am training for list 4 I can also help you with Elementary BD and Intermediate BE The times listed are a general guide of my availability. If you would prefer a time that is not listed please select the time that is closest to you preference, the message me via Email, WhatsApp or Facebook to see if we can arrange a better time for you. Instructions Make sure we have access to an arena, with a poop scoop and poles if you want them.

The course is designed to help improve your understanding of the legal requirements, the theoretical and practical principles for both the initial verification and certification of an electrical installation, further your knowledge and practical skills in the testing and inspection of a range of existing electrical installations, and help improve your understanding of the legal requirements, the theoretical and practical principles for the periodic inspect and testing and certification of an electrical installation.

The First Aid at Work qualification is the most comprehensive of all our first aid qualifications, and covers a wide range of skills which can be used within a workplace first aid situation, including: assessing the scene, managing an unresponsive casualty, CPR, heart attacks, choking, head and spinal injuries, fractures, anaphylaxis, plus much more.

Immediate life support, first aid

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.

Embark on a journey to become a workplace hero with our comprehensive one-day Pediatric First Aid course. This dynamic and engaging training program is designed to equip you with the essential skills and knowledge needed to handle emergency situations confidently and effectively.

The 2-hour Baby & Child First Aid class covers CPR, Choking, Bumps, Burns, Breaks, Bleeding, Febrile Seizures and Meningitis & Sepsis Awareness and will give everyone who attends the peace of mind they deserve.

Our *NEW* Mini First Aid Baby Proofing class is our second class, designed for parents and carers of babies and children over 3 months. It can be taken after our 2 hour Baby and Child First Aid class, or in isolation for those parents who are starting their weaning journey, or have a baby on the move!