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
ð« Preventing Electric Shock Online Training: Keep Yourself and Others Safe! Are you concerned about the risks of electric shock in your workplace or daily life? Look no further! Our Preventing Electric Shock Online Training course is your ultimate solution to mastering the art of electrical safety. With our comprehensive curriculum and expert-led guidance, you'll gain the knowledge and skills needed to prevent electric shock incidents and create a safer environment for yourself and others. ð Benefits of Taking Our Course: Enhanced Safety Awareness: Learn to identify potential electrical hazards and implement preventive measures to minimize the risk of electric shock. Confidence in Handling Electrical Equipment: Gain the confidence to handle electrical equipment safely, reducing the likelihood of accidents and injuries. Compliance with Safety Regulations: Understand the importance of compliance with safety regulations and standards, ensuring legal and ethical workplace practices. Empowerment to Protect Others: Equip yourself with the knowledge to educate and empower others about electrical safety, fostering a culture of safety awareness. Peace of Mind: Enjoy peace of mind knowing that you have the skills to prevent electric shock incidents and protect yourself and your colleagues from harm. ð¤ Who is this for? Our Preventing Electric Shock Online Training course is ideal for: Employees: Whether you work in construction, manufacturing, or any other industry, understanding electrical safety is essential for workplace well-being. Homeowners: Safeguard your home and loved ones by learning how to identify and mitigate electrical hazards in your household. Students: Electrical safety is relevant to students studying engineering, construction, or any field involving electrical systems. ð ï¸ Career Path: Upon completing our course, you'll be equipped with valuable skills that can enhance your career prospects in various industries, including: Electrical Engineering: Gain a competitive edge in the field of electrical engineering by demonstrating your commitment to safety and expertise in preventing electric shock incidents. Occupational Health and Safety: Pursue opportunities in occupational health and safety roles, where your knowledge of electrical safety will be highly valued. Facilities Management: Secure positions in facilities management, where your understanding of electrical safety can contribute to creating safer work environments. ð FAQ: Q: Is this course suitable for beginners? A: Absolutely! Our course is designed to cater to learners of all levels, from beginners to experienced professionals. We provide comprehensive training that covers the basics of electrical safety and gradually progresses to more advanced topics. Q: How long does it take to complete the course? A: The duration of the course varies depending on your pace of learning. On average, learners complete the course within a few hours, but you can take as much time as you need to absorb the content thoroughly. Q: Will I receive a certificate upon completion? A: Yes! Upon successfully completing the course, you'll receive a certificate of completion that validates your newfound knowledge and skills in preventing electric shock incidents. Q: Is the course content updated regularly? A: Yes, we strive to ensure that our course content is up-to-date with the latest industry standards and best practices. We regularly review and update the content to reflect any changes or advancements in the field of electrical safety. Q: Can I access the course materials on any device? A: Absolutely! Our course is accessible on various devices, including computers, tablets, and smartphones. You can learn anytime, anywhere, at your convenience. ð Don't Wait! Enroll Now and Empower Yourself with Electrical Safety Knowledge! Take the first step towards a safer workplace and a more secure future by enrolling in our Preventing Electric Shock Online Training course today. Together, let's prevent accidents, protect lives, and create a culture of safety awareness. Your safety journey begins now! ðð Course Curriculum Module 1 Introduction to Electric Shock Prevention Introduction to Electric Shock Prevention 00:00 Module 2 Electrical Hazards and Precautions Electrical Hazards and Precautions 00:00 Module 3 Electrical Equipment Safety Electrical Equipment Safety 00:00 Module 4 Electrical Safety Training for Employees Electrical Safety Training for Employees 00:00 Module 5 Electrical Safety for Managers and Supervisors Electrical Safety for Managers and Supervisors 00:00 Module 6 Electrical Safety for Office and Non-Technical Workers Electrical Safety for Office and Non-Technical Workers 00:00
Any business which involves food preparation and handling must adhere to legislation and regulation with regards to safety and hygiene. Make sure your workplace or employer is compliant by completing the Level 1 Food Hygiene and Safety course, which covers everything from cross-contamination and temperature control to cleaning and disinfection. You will also learn how to maintain a clean, healthy kitchen, with lessons delivered through videos, PDFs and online assessments. Why choose this course Earn an e-certificate upon successful completion. Accessible, informative modules taught by expert instructors Study in your own time, at your own pace, through your computer tablet or mobile device Benefit from instant feedback through mock exams and multiple-choice assessments Get 24/7 help or advice from our email and live chat teams Full Tutor Support on Weekdays Course Design The course is delivered through our online learning platform, accessible through any internet-connected device. There are no formal deadlines or teaching schedules, meaning you are free to study the course at your own pace. You are taught through a combination of Video lessons Online study materials Mock exams Multiple-choice assessment Certification After the successful completion of the final assessment, you will receive a CPD-accredited certificate of achievement. The PDF certificate is for £9.99, and it will be sent to you immediately after through e-mail. You can get the hard copy for £15.99, which will reach your doorsteps by post. Who is this course for? Level 1 Food Hygiene and Safety is suitable for anyone who want to gain extensive knowledge, potential experience and professional skills in the related field. This is a great opportunity for all student from any academic backgrounds to learn more on this subject.
This half-day Suicide First Aid Lite training course gives learners the knowledge and tools to understand that suicide is one of the most preventable deaths and some basic skills can help someone with thoughts of suicide stay safe from their thoughts and stay alive.
Fire Marshal Training (UK) - Level 3 CPD Certified Course offers essential skills and knowledge for individuals aiming to take on the critical role of fire marshals within various industries. This training is paramount in ensuring the safety and well-being of occupants in buildings by effectively managing fire risks and executing evacuation procedures. With stringent safety regulations in place, the demand for qualified fire marshals remains robust in the UK. The sector has witnessed a steady increase in demand, with a 10% rise in the number of trained fire marshals required across diverse sectors such as hospitality, healthcare, and commercial establishments. Pursuing this certification not only enhances one's employability but also contributes to safeguarding lives and property. On average, professionals holding Fire Marshal Training certification can expect to earn between £22,000 to £30,000 annually in the UK, depending on factors such as experience and location. Don't miss the opportunity to embark on a fulfilling career path while making a significant impact on fire safety standards. Key Features This Fire Marshal Training (UK) - Level 3 CPD Certified Course Includes : This Fire Marshal Training Course is CPD Certified Free Certificate Level 3 Diploma Developed by Specialist Lifetime Access Course Curriculum Fire Marshal Training (UK) - Level 3 CPD Certified Course : Module 01: Fundamentals of Fire Safety Module 02: Fire Warden Introduction Module 03: Preventive Responsibilities Module 04: Emergency Tasks and Attributes Module 05: Fire Safety Protocols Module 06: Evacuation Tactics Module 07: Regulatory Compliance and Risk Assessment Learning Outcomes Fire Marshal Training (UK) - Level 3 CPD Certified Course: Identify fire hazards and apply basic safety protocols. Demonstrate understanding of fire warden roles and responsibilities. Execute preventive duties to minimise fire risks effectively. Exhibit emergency response skills and essential qualities during crises. Implement approved fire safety measures in diverse settings. Develop comprehensive evacuation strategies adhering to regulations and risk assessment. Certification After completing this Fire Marshal Training (UK) - Level 3 CPD Certified course, you will get a free Certificate. CPD 10 CPD hours / points Accredited by The CPD Quality Standards (CPD QS) Who is this course for? Fire Marshal Training (UK) - Level 3 CPD Certified Individuals seeking fire safety certification for workplace responsibilities. Employees designated or aspiring to be fire wardens. Safety officers and managers responsible for preventive measures. Personnel involved in emergency response planning and execution. Facilities management professionals ensuring fire safety compliance. Career path Fire Marshal Training (UK) - Level 3 CPD Certified Fire Warden Coordinator - £30K to 45K/year. Facilities Compliance Specialist - £25K to 40K/year. Fire Marshal - £25K to 35K/year. Health and Safety Officer - £30K to 40K/year. Emergency Response Coordinator - £28K to 38K/year. Fire Safety Inspector - £32K to 42K/year. Risk Assessment Specialist - £28K to 38K/year. Certificates Certificate of Completion Digital certificate - Included Will be downloadable when all lectures have been completed.
Embark on a journey to become a workplace hero with our comprehensive one-day 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.
Gain essential first aid skills and knowledge with our Emergency First Aid at Work Course. Learn how to manage incidents effectively, provide first aid, and respond to various injuries and medical conditions. Suitable for individuals in various workplaces and those interested in workplace safety.
Embark on a journey to become a workplace hero with our comprehensive one-day 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.