Do you want to prepare for your dream job but strive hard to find the right courses? Then, stop worrying, for our strategically modified Financial Management and Financial Modeling bundle will keep you up to date with the relevant knowledge and most recent matters of this emerging field. So, invest your money and effort in our 33 course mega bundle that will exceed your expectations within your budget. The Financial Management and Financial Modeling related fields are thriving across the UK, and recruiters are hiring the most knowledgeable and proficient candidates. It's a demanding field with magnitudes of lucrative choices. If you need more guidance to specialise in this area and need help knowing where to start, then StudyHub proposes a preparatory bundle. This comprehensive Financial Management and Financial Modeling bundle will help you build a solid foundation to become a proficient worker in the sector. This Financial Management and Financial Modeling Bundle consists of the following 30 CPD Accredited Premium courses - Course 01:Financial Consultant Training Course 02:Making Budget & Forecast Course 03:Business Model Canvas for Business Plan Course 04:Dealing With Uncertainity: Make Budgets and Forecasts Course 05:Financial Modeling Using Excel Course 06:Debt Management - Online Course Course 07:Forensic accounting Course 08:Pension UK Course 09:GDPR Course 10:Excel Pivot Tables for Data Reporting Course 11:Personal Productivity Course Course 12:Time Management Training - Online Course Course 13:Sage 50 Accounts Course 14:Financial Statements Fraud Detection Training Course 15:Anti-Money Laundering (AML) Training Course 16:Document Control Course 17:Corporate & Strategic Communication Skills for Managers Course 18:Excel Vlookup, Xlookup, Match and Index Course 19:Financial Reporting Course 20:Learn to Read, Analyse and Understand Annual Reports Course 21:Accounting Basics Course 22:Bookkeeper Training Course Course 23:Xero Accounting and Bookkeeping Online Course 24:Quickbooks Online Course 25:Financial Management Course 26:Commercial Law Course 27:UK Tax Accounting Course 28:Cost Control & Project Scheduling Course 29:Dynamic Excel Gantt Chart and Timelines Course 30:Understanding Financial Statements and Analysis 3 Extraordinary Career Oriented courses that will assist you in reimagining your thriving techniques- Course 01: Career Development Plan Fundamentals Course 02: CV Writing and Job Searching Course 03: Interview Skills: Ace the Interview Learning Outcome This tailor-made Financial Management and Financial Modeling bundle will allow you to- Uncover your skills and aptitudes to break new ground in the related fields Deep dive into the fundamental knowledge Acquire some hard and soft skills in this area Gain some transferable skills to elevate your performance Maintain good report with your clients and staff Gain necessary office skills and be tech savvy utilising relevant software Keep records of your work and make a report Know the regulations around this area Reinforce your career with specific knowledge of this field Know your legal and ethical responsibility as a professional in the related field This Financial Management and Financial Modeling Bundle resources were created with the help of industry experts, and all subject-related information is kept updated on a regular basis to avoid learners from falling behind on the latest developments. Certification After studying the complete training you will be able to take the assessment. After successfully passing the assessment you will be able to claim all courses pdf certificates and 1 hardcopy certificate for the Title Course completely free. Other Hard Copy certificates need to be ordered at an additional cost of •8. CPD 330 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Ambitious learners who want to strengthen their CV for their desired job should take advantage of the Financial Management and Financial Modeling bundle! This bundle is also ideal for professionals looking for career advancement. Please Note: Studyhub is a Compliance Central approved resale partner for Quality Licence Scheme Endorsed courses. Requirements To participate in this course, all you need is - A smart device A secure internet connection And a keen interest in Financial Management and Financial Modeling Career path Upon completing this essential Bundle, you will discover a new world of endless possibilities. These courses will help you to get a cut above the rest and allow you to be more efficient in the relevant fields.
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Quality Guarantee: Promising training excellence, satisfaction gurantee Accredited by CPD UK & Quality License Scheme Tutor Support Unlimited support via email, till you complete the course Recognised Certification: Accepted by thousands of professional bodies Start Anytime With 1 year access to the course materials Online Learning Learn from anywhere, whenever you want Why Integrative Process - Sustainable Building Design Course right for you? Whether you are self-taught and you want to fill in the gaps for better efficiency and productivity, this Integrative Process - Sustainable Building Design course will set you up with a solid foundation to become a confident building designer or architecture and develop more advanced skills. This comprehensive Integrative Process - Sustainable Building Design course is the perfect way to kickstart your career in the field of sustainable building design. This course will give you a competitive advantage in your career, making you stand out from all other applicants and employees. As one of the leading course providers and most renowned e-learning specialists online, we're dedicated to giving you the best educational experience possible. This course is crafted by industry expert, to enable you to learn quickly and efficiently, and at your own pace and convenience. Integrative Process - Sustainable Building Design Course Details Accredited by CPD certificates are accepted by thousands of professional bodies and government regulators here in the UK and around the world. Many organisations look for employees with CPD requirements, which means, that by doing this course, you would be a potential candidate in your respective field. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. Course Curriculum Introduction Course Introduction Introduction to Integrative Process Integrative process at work LEED & Integrative process LEED BD+C Integrative process credit Who should take this course? This comprehensive Integrative Process - Sustainable Building Design course is suitable for anyone looking to improve their job prospects or aspiring to accelerate their career in this sector and want to gain in-depth knowledge of sustainable building design. Entry Requirements There are no academic entry requirements for this Integrative Process - Sustainable Building Design course, and it is open to students of all academic backgrounds. As long as you are aged seventeen or over and have a basic grasp of English, numeracy and ICT, you will be eligible to enrol. Assessment Method On successful completion of the course, you will be required to sit an online multiple-choice assessment. The assessment will be evaluated automatically and the results will be given to you immediately. Certification Endorsed Certificate from Quality Licence Scheme After successfully passing the MCQ exam you will be eligible to order the Endorsed Certificate by Quality Licence Scheme. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. It will give you a competitive advantage in your career, making you stand out from all other applicants and employees. There is a Quality Licence Scheme endorsement fee to obtain an endorsed certificate which is £65. Certificate of Achievement from Lead Academy After successfully passing the MCQ exam you will be eligible to order your certificate of achievement as proof of your new skill. The certificate of achievement is an official credential that confirms that you successfully finished a course with Lead Academy. Certificate can be obtained in PDF version at a cost of £12, and there is an additional fee to obtain a printed copy certificate which is £35. FAQs Is CPD a recognised qualification in the UK? CPD is globally recognised by employers, professional organisations and academic intuitions, thus a certificate from CPD Certification Service creates value towards your professional goal and achievement. CPD-certified certificates are accepted by thousands of professional bodies and government regulators here in the UK and around the world. Are QLS courses recognised? Although QLS courses are not subject to Ofqual regulation, they must adhere to an extremely high level that is set and regulated independently across the globe. A course that has been approved by the Quality Licence Scheme simply indicates that it has been examined and evaluated in terms of quality and fulfils the predetermined quality standards. When will I receive my certificate? For CPD accredited PDF certificate it will take 24 hours, however for the hardcopy CPD certificate takes 5-7 business days and for the Quality License Scheme certificate it will take 7-9 business days. Can I pay by invoice? Yes, you can pay via Invoice or Purchase Order, please contact us at info@lead-academy.org for invoice payment. Can I pay via instalment? Yes, you can pay via instalments at checkout. How to take online classes from home? Our platform provides easy and comfortable access for all learners; all you need is a stable internet connection and a device such as a laptop, desktop PC, tablet, or mobile phone. The learning site is accessible 24/7, allowing you to take the course at your own pace while relaxing in the privacy of your home or workplace. Does age matter in online learning? No, there is no age limit for online learning. Online learning is accessible to people of all ages and requires no age-specific criteria to pursue a course of interest. As opposed to degrees pursued at university, online courses are designed to break the barriers of age limitation that aim to limit the learner's ability to learn new things, diversify their skills, and expand their horizons. When I will get the login details for my course? After successfully purchasing the course, you will receive an email within 24 hours with the login details of your course. Kindly check your inbox, junk or spam folder, or you can contact our client success team via info@lead-academy.org
Quality Guarantee: Promising training excellence, satisfaction gurantee Accredited by CPD UK & Quality License Scheme Tutor Support Unlimited support via email, till you complete the course Recognised Certification: Accepted by thousands of professional bodies Start Anytime With 1 year access to the course materials Online Learning Learn from anywhere, whenever you want Why Sustainable Thinking For Green Buildings Course right for you? Whether you are self-taught and you want to fill in the gaps for better efficiency and productivity, this Sustainable Thinking For Green Buildings course will set you up with a solid foundation to become a confident architecture and develop more advanced skills. This comprehensive Sustainable Thinking For Green Buildings course is the perfect way to kickstart your career in the field of green buildings. This course will give you a competitive advantage in your career, making you stand out from all other applicants and employees. As one of the leading course providers and most renowned e-learning specialists online, we're dedicated to giving you the best educational experience possible. This course is crafted by industry expert, to enable you to learn quickly and efficiently, and at your own pace and convenience. Sustainable Thinking For Green Buildings Course Details Accredited by CPD certificates are accepted by thousands of professional bodies and government regulators here in the UK and around the world. Many organisations look for employees with CPD requirements, which means, that by doing this course, you would be a potential candidate in your respective field. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. Course Curriculum Introduction Course Introduction Introduction Systems Thinking Life Cycle Approach Integrative process Sustainable thinking at work Who should take this course? This comprehensive Sustainable Thinking For Green Buildings course is suitable for anyone looking to improve their job prospects or aspiring to accelerate their career in this sector and want to gain in-depth knowledge of green buildings. Entry Requirements There are no academic entry requirements for this Sustainable Thinking For Green Buildings course, and it is open to students of all academic backgrounds. As long as you are aged seventeen or over and have a basic grasp of English, numeracy and ICT, you will be eligible to enrol. Assessment Method On successful completion of the course, you will be required to sit an online multiple-choice assessment. The assessment will be evaluated automatically and the results will be given to you immediately. Certification Endorsed Certificate from Quality Licence Scheme After successfully passing the MCQ exam you will be eligible to order the Endorsed Certificate by Quality Licence Scheme. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. It will give you a competitive advantage in your career, making you stand out from all other applicants and employees. There is a Quality Licence Scheme endorsement fee to obtain an endorsed certificate which is £65. Certificate of Achievement from Lead Academy After successfully passing the MCQ exam you will be eligible to order your certificate of achievement as proof of your new skill. The certificate of achievement is an official credential that confirms that you successfully finished a course with Lead Academy. Certificate can be obtained in PDF version at a cost of £12, and there is an additional fee to obtain a printed copy certificate which is £35. FAQs Is CPD a recognised qualification in the UK? CPD is globally recognised by employers, professional organisations and academic intuitions, thus a certificate from CPD Certification Service creates value towards your professional goal and achievement. CPD-certified certificates are accepted by thousands of professional bodies and government regulators here in the UK and around the world. Are QLS courses recognised? Although QLS courses are not subject to Ofqual regulation, they must adhere to an extremely high level that is set and regulated independently across the globe. A course that has been approved by the Quality Licence Scheme simply indicates that it has been examined and evaluated in terms of quality and fulfils the predetermined quality standards. When will I receive my certificate? For CPD accredited PDF certificate it will take 24 hours, however for the hardcopy CPD certificate takes 5-7 business days and for the Quality License Scheme certificate it will take 7-9 business days. Can I pay by invoice? Yes, you can pay via Invoice or Purchase Order, please contact us at info@lead-academy.org for invoice payment. Can I pay via instalment? Yes, you can pay via instalments at checkout. How to take online classes from home? Our platform provides easy and comfortable access for all learners; all you need is a stable internet connection and a device such as a laptop, desktop PC, tablet, or mobile phone. The learning site is accessible 24/7, allowing you to take the course at your own pace while relaxing in the privacy of your home or workplace. Does age matter in online learning? No, there is no age limit for online learning. Online learning is accessible to people of all ages and requires no age-specific criteria to pursue a course of interest. As opposed to degrees pursued at university, online courses are designed to break the barriers of age limitation that aim to limit the learner's ability to learn new things, diversify their skills, and expand their horizons. When I will get the login details for my course? After successfully purchasing the course, you will receive an email within 24 hours with the login details of your course. Kindly check your inbox, junk or spam folder, or you can contact our client success team via info@lead-academy.org
In the captivating world of modern science, there exists a gateway to understanding the intricate workings of life at its most fundamental level. Delve into the microscopic universe with our comprehensive online journey, where every click opens doors to new realms of knowledge. From the mysterious realm of Bacteriology to the captivating intricacies of Immunology, embark on an odyssey that promises to enlighten and empower. Key Features: CPD Certified Free Certificate from Reed CIQ Approved Developed by Specialist Lifetime Access Within these digital halls of learning, discover the secrets of viruses, from the enigmatic DNA entities to the elusive RNA strands, each holding keys to unlocking nature's mysteries. Traverse through the labyrinthine landscapes of Parasites and Fungi, and learn to navigate the delicate balance between their existence and ours. Engage with the arsenal of Antifungal Medicines and Antibiotics, understanding their vital role in combating the unseen threats that lurk in the shadows. And as the journey unfolds, delve into the realms of Sexually Transmitted Diseases, gaining insights that transcend mere understanding, leading to informed action and empowered decision-making. In this online haven of intellectual exploration, seize the opportunity to broaden horizons and deepen understanding. Enrich your mind and equip yourself with knowledge that transcends boundaries, opening doors to new possibilities and unlocking the secrets of the unseen world around us. Join us on this exhilarating voyage, where curiosity meets enlightenment, and every discovery brings us closer to the essence of life itself. Course Curriculum Module 01: Introduction to Microbiology Bacteriology Viruses DNA Viruses Positive-Strand RNA Viruses Negative-Strand RNA Viruses Module 02: Parasites Fungi Antifungal Medicines Immunology Antibiotics Sexually Transmitted Diseases Learning Outcomes: Identify different types of microbes and their characteristics accurately. Understand the structure and function of bacteria and viruses comprehensively. Analyze the role of parasites and fungi in microbiological contexts. Demonstrate knowledge of immunology principles and their applications effectively. Evaluate the mechanism of action of antibiotics and antifungal medicines critically. Recognize the transmission and management of sexually transmitted diseases proficiently. CPD 10 CPD hours / points Accredited by CPD Quality Standards Module 01: 1:18:13 1: Introduction to Microbiology 12:44 2: Bacteriology 18:16 3: Viruses 11:19 4: DNA Viruses 14:11 5: Positive-Strand RNA Viruses 12:05 6: Negative-Strand RNA Viruses 09:38 Module 02: 1:09:46 7: Parasites 09:07 8: Fungi 08:16 9: Antifungal Medicines 10:23 10: Immunology 18:34 11: Antibiotics 10:45 12: Sexually Transmitted Diseases 11:41 13: CPD Certificate - Free 01:00 Who is this course for? Biology enthusiasts seeking specialised knowledge. Healthcare professionals expanding their expertise. Students pursuing careers in medical research. Individuals interested in laboratory-based careers. Anyone fascinated by the microscopic world of pathogens. Career path Microbiologist Laboratory Technician Clinical Research Associate Infection Control Practitioner Pharmaceutical Sales Representative Public Health Officer Certificates Digital certificate Digital certificate - Included Reed Courses Certificate of Completion Digital certificate - Included Will be downloadable when all lectures have been completed.
In the captivating world of modern science, there exists a gateway to understanding the intricate workings of life at its most fundamental level. Delve into the microscopic universe with our comprehensive online journey, where every click opens doors to new realms of knowledge. From the mysterious realm of Bacteriology to the captivating intricacies of Immunology, embark on an odyssey that promises to enlighten and empower. Key Features: CPD Certified Free Certificate from Reed CIQ Approved Developed by Specialist Lifetime Access Within these digital halls of learning, discover the secrets of viruses, from the enigmatic DNA entities to the elusive RNA strands, each holding keys to unlocking nature's mysteries. Traverse through the labyrinthine landscapes of Parasites and Fungi, and learn to navigate the delicate balance between their existence and ours. Engage with the arsenal of Antifungal Medicines and Antibiotics, understanding their vital role in combating the unseen threats that lurk in the shadows. And as the journey unfolds, delve into the realms of Sexually Transmitted Diseases, gaining insights that transcend mere understanding, leading to informed action and empowered decision-making. In this online haven of intellectual exploration, seize the opportunity to broaden horizons and deepen understanding. Enrich your mind and equip yourself with knowledge that transcends boundaries, opening doors to new possibilities and unlocking the secrets of the unseen world around us. Join us on this exhilarating voyage, where curiosity meets enlightenment, and every discovery brings us closer to the essence of life itself. Course Curriculum Module 01: Introduction to Microbiology Bacteriology Viruses DNA Viruses Positive-Strand RNA Viruses Negative-Strand RNA Viruses Module 02: Parasites Fungi Antifungal Medicines Immunology Antibiotics Sexually Transmitted Diseases Learning Outcomes: Identify different types of microbes and their characteristics accurately. Understand the structure and function of bacteria and viruses comprehensively. Analyze the role of parasites and fungi in microbiological contexts. Demonstrate knowledge of immunology principles and their applications effectively. Evaluate the mechanism of action of antibiotics and antifungal medicines critically. Recognize the transmission and management of sexually transmitted diseases proficiently. CPD 10 CPD hours / points Accredited by CPD Quality Standards Module 01: 1:18:13 1: Introduction to Microbiology 12:44 2: Bacteriology 18:16 3: Viruses 11:19 4: DNA Viruses 14:11 5: Positive-Strand RNA Viruses 12:05 6: Negative-Strand RNA Viruses 09:38 Module 02: 1:09:46 7: Parasites 09:07 8: Fungi 08:16 9: Antifungal Medicines 10:23 10: Immunology 18:34 11: Antibiotics 10:45 12: Sexually Transmitted Diseases 11:41 13: CPD Certificate - Free 01:00 Who is this course for? Biology enthusiasts seeking specialised knowledge. Healthcare professionals expanding their expertise. Students pursuing careers in medical research. Individuals interested in laboratory-based careers. Anyone fascinated by the microscopic world of pathogens. Career path Microbiologist Laboratory Technician Clinical Research Associate Infection Control Practitioner Pharmaceutical Sales Representative Public Health Officer Certificates Digital certificate Digital certificate - Included Reed Courses Certificate of Completion Digital certificate - Included Will be downloadable when all lectures have been completed.
Description: The world can sometimes be a genuinely distressing place for many reasons. It's impossible to get rid of stress completely. However, you can learn some of the tips and tricks to enable you to adapt or overcome at whatever point you keep running into it. Learn about how to deal with stress in your life including at the work environment. You will learn stress awareness, management, and prosperity in this online course bundle. In this course, students will have more understanding of what stress is and gain more strategies for how to manage stress. You will be equipped with necessary skills, information, and knowledge of stress related issues and stress management. Who is this course for? This course would be ideal for anyone who needs to understand stress management. Senior/junior managers, directors, administrators, customer service professionals and technical staff. Entry Requirement: This course is available to all learners, of all academic backgrounds. Learners should be aged 16 or over to undertake the qualification. Good understanding of English language, numeracy and ICT are required to attend this course. Assessment: At the end of the course, you will be required to sit an online multiple-choice test. Your test will be assessed automatically and immediately so that you will instantly know whether you have been successful. Before sitting for your final exam, you will have the opportunity to test your proficiency with a mock exam. Certification: After you have successfully passed the test, you will be able to obtain an Accredited Certificate of Achievement. You can however also obtain a Course Completion Certificate following the course completion without sitting for the test. Certificates can be obtained either in hard copy at the cost of £39 or in PDF format at the cost of £24. PDF certificate's turnaround time is 24 hours, and for the hardcopy certificate, it is 3-9 working days. Why choose us? Affordable, engaging & high-quality e-learning study materials; Tutorial videos/materials from the industry leading experts; Study in a user-friendly, advanced online learning platform; Efficient exam systems for the assessment and instant result; The UK & internationally recognized accredited qualification; Access to course content on mobile, tablet or desktop from anywhere anytime; The benefit of career advancement opportunities; 24/7 student support via email. Stress Management Basics Introduction 00:15:00 Recognizing your stress Levels & triggers 01:00:00 Why do these changes occur frequently? 00:15:00 What does stress do to you? 00:15:00 Beware! Before seeking medical attention 00:30:00 Medical stress solutions analyzing 00:30:00 The importance of stress management 01:00:00 Other things that might help in Stress Management 00:30:00 The Uses of Herbs and supplements in stress Management for stress relief 01:00:00 Conclusion 00:15:00 Applying Reiki Method What Is Reiki? 01:00:00 Learning about Reiki 01:00:00 Sides Effects of Reiki 01:00:00 Reiki Healing Health Benefits 01:00:00 Reiki And Creative Problem Solving 00:30:00 Essential Benefits Of Reiki 01:00:00 Strengthen Your Reiki Energy 01:00:00 Additional Treatment Advantages Of Reiki 01:00:00 What to Expect from Reiki Practice 01:00:00 Drawbacks of Not Using Reiki 01:00:00 Wrapping Up 00:15:00 Advanced Techniques What Is Stress? 00:30:00 Causes Of Stress 01:00:00 The Effects Of Stress 00:30:00 Recognise The Warning Signs 00:15:00 Lingering Stress 00:15:00 Stress And Panic Attacks 00:30:00 Solutions On Living A Stress-Free Life 01:30:00 Conclusion 00:15:00 Mock Exam Mock Exam- Stress Management Bundle Course 00:30:00 Final Exam Final Exam- Stress Management Bundle Course 00:30:00 Certificate and Transcript Order Your Certificates and Transcripts 00:00:00
If you wish to grow your fitness business with maximum profit in minimal time, this online course can make all the difference between success and failure! This course is best suited to anyone looking to market their fitness business online and gain a comprehensive understanding of the market's landscape. In this course, we will introduce you with a few tested and trusted approaches for maximising profits in the relevant sector. Don't just leave wondering how to achieve the dream lifestyle you're chasing! Enrol in this course today and expand your fitness empire to achieve your goals. Learning Outcomes Create valuable promotion packages at bargain prices that cannot be ignored by your clients Understand your own value proposition and what expand your client base Discover ways to get yourself noticed by the targeted audience online Have a better understanding of Client Avatar Creation (CAC) Get plenty of tips and tricks for building your fitness business Develop your knowledge of how and where to attract clients Learn to close the deal and understand the principles of persuasion Unveil the secrets that keep clients happy and wanting more Quit wasting time and money in guessing how to grow your business Leave well-equipped with information on the business side to health and fitness Marketing Your Fitness Business Online Introduction 00:10:00 Module 1: Understanding your own value proposition. 00:10:00 Module 2: Testing you Value Proposition 00:15:00 Module 3: What does your client Avatar look like? Client Avatar Creation (CAC) 00:40:00 Module 4: Where does your Avatar hang out? You need to hang out with them 00:10:00 Module 5: How much can your Avatar afford? - create a price list & know your prices! 00:15:00 Module 6: Creating Value & your Brand, make your Avatar need you 00:15:00 Module 7: Where do you attract clients? 00:30:00 Module 8: Ways to Get Yourself Noticed 01:00:00 Module 9: Top Tips for Building you Fitness Business 00:15:00 Module 10: Closing the deal & the principles of persuasion. 00:20:00 Module 11: Teaching Classes and Personal Training Online 00:20:00 Module 12: Keeping clients happy and wanting more 00:05:00
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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