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The Business Value of Risk Management - Risk Management is Not Optional What is value? More to the point, what is business value? If value is in the 'eyes of the beholder,' how can we reach consensus? If we do reach consensus, how do we know it is real value? The answers to these questions are critical because they are the reasons for your portfolio, program, or project. There is a direct correlation between value and performance. This presentation will provide guidance that you can apply to virtually any situation, and address the relationship between risk and business value. This and other IIL Learning in Minutes presentations qualify for PDUs. Some titles, such as Agile-related topics may qualify for other continuing education credits such as SEUs, or CEUs. Each professional development activity yields one PDU for one hour spent engaged in the activity. Some limitations apply and can be found in the Ways to Earn PDUs section that discusses PDU activities and associated policies. Fractions of PDUs may also be reported. The smallest increment of a PDU that can be reported is 0.25. This means that if you spent 15 minutes participating in a qualifying PDU activity, you may report 0.25 PDU. If you spend 30 minutes in a qualifying PDU activity, you may report 0.50 PDU.

48-Hour Knowledge Knockdown! Prices Reduced Like Never Before! Boost Your Career By Enrolling In This Safeguarding Children Bundle To Overcome Your Challenges! 11 in-1 Safeguarding Children Bundle If you aim to enhance your Safeguarding Children skills, our comprehensive Safeguarding Children course is perfect for you. Designed for success, this Safeguarding Children course covers everything from basics to advanced topics in Safeguarding Children. Each lesson in this Safeguarding Children course is crafted for easy understanding, enabling you to become proficient in Safeguarding Children. Whether you are a beginner or looking to sharpen your existing Nursing skills, Safeguarding Children is the ideal choice. With a single payment, you will gain access to the Safeguarding Children course, including 10 premium courses, a QLS Endorsed Hardcopy certificate (for the title course) and 11 PDF certificates for Absolutely free. This Safeguarding Children Bundle Package includes: Course 01: Diploma in Safeguarding Children at QLS Level 5 10 Additional CPDQS Accredited Premium Courses - Course 01: Child Development & Psychology Diploma Course 02: Learning Support Assistant Course 03: Family Law Course 04: Nursery Nurse for Development of Children Course 05: Foster Care Training Course Course 06: Understanding Autism Level 3 Course 07: Challenging Behaviour in Children Course 08: Speech & Language Therapy for Children Course 09: Cognitive Behavioural Therapy (CBT) Practitioner Course 10: Dyslexia Awareness Training With our Safeguarding Children exclusive bundle, you will get PDF Certificate, PDF Transcript and Digital Student ID Card (worth £50) Absolutely FREE. Success becomes a lot simpler with this bundle package, which allows you to monetise your skills. This bundle is appropriate for both part-time and full-time students, and it can be completed at your own pace. This premium bundle of courses helps your professional development by receiving an endorsement from the Quality Licence Scheme and CPDQS Accredited Certificate. You'll be able to practice in your own time and speed. Learning Outcome of Safeguarding Children Recognize signs of child abuse and neglect in various contexts and age groups. Understand legal and ethical responsibilities related to child protection and reporting. Develop effective communication skills to engage with children, families, and professionals. Apply risk assessment and decision-making frameworks to safeguard children's well-being. Collaborate with multi-agency teams to coordinate interventions and support for vulnerable children. Promote a culture of continuous learning and improvement in child safeguarding practices. Why Choose Our Safeguarding Children Course? FREE Safeguarding Children certificate accredited Get a free student ID card with this Bundle Get instant access to this Bundle course. Learn this bundle from anywhere in the world this Bundle is affordable and simple to understand The Safeguarding Children is an entirely online, interactive lesson with voiceover audio Lifetime access to the Safeguarding Children course materials The Safeguarding Children comes with 24/7 tutor support So enrol now in this Safeguarding Children Today to advance your career! Take a step toward a brighter future! Course 01: Diploma in Safeguarding Children at QLS Level 5 Module 1: Laws & Guidance Module 2: Social & Emotional Development Module 3: Personality & Intellectual Development of Children Module 4: Child Abuse Module 5: Sexual Abuse Module 6: The Impact of Domestic Violence & Abuse on Children Module 7: Risks & Risk Assessment Module 8: Responding to Disclosure & Reporting Module 9: Things to Do After Referral Module 10: Safeguarding Trafficked Children Module 11: Infant Mental Health & Early Attachment Module 12: Assessing Need & Providing Early Help Assessment Process You have to complete the assignment questions given at the end of the course and score a minimum of 60% to pass each exam. Our expert trainers will assess your assignment and give you feedback after you submit the assignment. You will be entitled to claim a certificate endorsed by the Quality Licence Scheme after you have completed all of the Diploma in Safeguarding Children at QLS Level 5 exams. CPD 250 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This Safeguarding Children bundle is perfect for highly motivated people who want to improve their technical skills and prepare for the career they want! Requirements No prior background or expertise is required for this Safeguarding Children Course. Career path The Safeguarding Children bundle aims to help you get the job or even the long-awaited promotion of your dreams. Certificates CPD Accredited Certificate Digital certificate - Included Upon passing the Bundle, you need to order to receive a Digital Certificate for each of the courses inside this bundle as proof of your new skills that are accredited by CPD. Diploma in Safeguarding Children at QLS Level 5 Hard copy certificate - Included

Are you ready to embark on an enlightening journey of wisdom with the Business Development bundle, and pave your way to an enriched personal and professional future? If so, then Step into a world of knowledge with our course bundle - Business Development, Leadership & Business Studies. Delve into eight immersive CPD Accredited courses, each a standalone course: Course 01: Business Development Fundementals: Lean Strategies for Business Course 02: Strategic Business Management - Online Diploma Course Course 03: Business Law 2021 Course 04: Business Studies Course 05: Business Analysis Course Level 5 Course 06: Leadership and Management Course Course 07: Accounting and Finance Course 08: Risk Assessment & Management Diploma Traverse the vast landscapes of theory, unlocking new dimensions of understanding at every turn. Let the Business Development, Leadership & Business Studies bundle illuminate your path to wisdom. The Business Development, Leadership & Business Studies bundle offers a comprehensive exploration into a rich tapestry of vast knowledge across eight carefully curated courses. The journey is designed to enhance your understanding and critical thinking skills. Each course within the bundle provides a deep-dive into complex theories, principles, and frameworks, allowing you to delve into the nuances of the subject matter at your own pace. In the framework of the Business Development, Leadership & Business Studies package, you are bestowed with complimentary PDF certificates for all the courses included in this bundle, all without any additional charge. Adorn yourself with the Business Development bundle, empowering you to traverse your career trajectory or personal growth journey with self-assurance. Register today and ignite the spark of your professional advancement! So, don't wait further and join the Business Development, Leadership & Business Studies community today and let your voyage of discovery begin! Learning Outcomes: Attain a holistic understanding in the designated areas of study with the Business Development bundle. Establish robust bases across each course nestled within the Business Development bundle. Decipher intricate concepts through the articulate content of the Business Development bundle. Amplify your prowess in interpreting, scrutinising, and implementing theories. Procure the capacity to engage with the course material on an intellectual and profound level. Become proficient in the art of problem-solving across various disciplines. Stepping into the Business Development bundle is akin to entering a world overflowing with deep theoretical wisdom. Each course within this distinctive bundle is an individual journey, meticulously crafted to untangle the complex web of theories, principles, and frameworks. Learners are inspired to explore, question, and absorb, thus enhancing their understanding and honing their critical thinking skills. Each course invites a personal and profoundly enlightening interaction with knowledge. The Business Development bundle shines in its capacity to cater to a wide range of learning needs and lifestyles. It gives learners the freedom to learn at their own pace, forging a unique path of discovery. More than just an educational journey, the Business Development bundle fosters personal growth, enabling learners to skillfully navigate the complexities of the world. The Business Development bundle also illuminates the route to a rewarding career. The theoretical insight acquired through this bundle forms a strong foundation for various career opportunities, from academia and research to consultancy and programme management. The profound understanding fostered by the Business Development bundle allows learners to make meaningful contributions to their chosen fields. Embark on the Business Development journey and let knowledge guide you towards a brighter future. CPD 80 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Individuals keen on deepening their firm understanding in the respective fields. Students pursuing higher education looking for comprehensive theory modules. Professionals seeking to refresh or enhance their knowledge. Anyone with a thirst for knowledge and a passion for continuous learning. Career path Armed with the Business Development bundle, your professional journey can reach new heights. The comprehensive theoretical knowledge from this bundle can unlock diverse career opportunities across several fields. Whether it's academic research, consultancy, or programme management, the Business Development bundle lays a solid groundwork. Certificates CPD Certificate Of Completion Digital certificate - Included 8 Digital Certificates Are Included With This Bundle CPD Quality Standard Hardcopy Certificate (FREE UK Delivery) Hard copy certificate - £9.99 Hard copy Transcript - £9.99

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This course unveils the crucial synergy between strategy and risk, emphasizing their paramount importance in organizational development. Delve into the strategic plan reviewing process, explore diverse types of strategic analysis, and gain proficiency in using tools for informed decision-making. Equip yourself with the skills to conduct Value Chain Analysis and competitive analysis, fostering a deep understanding of market dynamics. This course is a comprehensive exploration of risk analysis standard tools and models. It covers the strategic plan reviewing process, various types of strategic analysis, and the application of tools in strategic formulation. Participants will navigate the step-by-step process of Value Chain Analysis, gaining insights into competitive advantages. Additionally, the course highlights the benefits of competitive analysis for making informed business decisions. After the successful completion of this course, you will be able: ⦁ Understand the importance of reviewing strategy and risk. ⦁ Demonstrate knowledge of the strategic plan reviewing process and its role in organizational development. ⦁ Identify the different types of strategic analysis and their applications in formulating business strategies. ⦁ Describe the various tools used in strategic analysis. ⦁ Comprehend the step-by-step process of conducting Value Chain Analysis to assess a company's competitive advantage. ⦁ Recognize the benefits of competitive analysis in understanding market dynamics and making informed business decisions. Dive into the realm of risk analysis with precision through our specialized course. Explore industry-standard tools and models meticulously designed to sharpen your ability in evaluating and managing risks effectively. This hands-on program equips you with the expertise needed to employ both quantitative and qualitative analysis methods. Elevate your strategic decision-making by mastering these essential risk analysis frameworks, ensuring you become an invaluable asset in navigating complexities within any professional landscape. Course Structure and Assessment Guidelines Watch this video to gain further insight. Navigating the MSBM Study Portal Watch this video to gain further insight. Interacting with Lectures/Learning Components Watch this video to gain further insight. Risk Analysis Standards, Tools and Models - Part 1 Self-paced pre-recorded learning content on this topic. Risk Analysis Standard Tools And Models Put your knowledge to the test with this quiz. Read each question carefully and choose the response that you feel is correct. All MSBM courses are accredited by the relevant partners and awarding bodies. Please refer to MSBM accreditation in about us for more details. There are no strict entry requirements for this course. Work experience will be added advantage to understanding the content of the course. The certificate is designed to enhance the learner's knowledge in the field. This certificate is for everyone eager to know more and get updated on current ideas in their respective field. We recommend this certificate for the following audience.  1. Risk Analysts 2. Financial Planners 3. Project Managers 4. Compliance Officers 5. Data Scientists Average Completion Time 2 Weeks Accreditation 3 CPD Hours Level Advanced Start Time Anytime 100% Online Study online with ease. Unlimited Access 24/7 unlimited access with pre-recorded lectures. Low Fees Our fees are low and easy to pay online.

Embark on a journey of knowledge with our Surveying Diploma - Level 5 bundle! Our courses are designed to equip learners with the essential skills and knowledge required to excel in the field of surveying. Whether you are a budding surveyor looking to start your career or an experienced professional seeking to expand your skillset, our bundle has something for everyone. The first course in our bundle is QLS-endorsed, and you will receive a QLS hardcopy certificate for free upon completion. This certificate is essential for anyone looking to progress in their surveying career, as it serves as proof of your competence and expertise. With our QLS-endorsed course, you can be confident that you are learning from the best. The remaining 10 courses in our bundle are CPD-QS accredited and cover a range of essential topics, including basics of surveying, quantity surveying, land surveying, building quantity surveying, and more. Our courses will teach you how to manage construction sites effectively, ensure safety, and assess risks. You will also learn about construction cost estimation using Xactimate and RSMeans. By enrolling in our Surveying Diploma - Level 5 bundle, you will gain a comprehensive understanding of surveying principles and practices. You will be equipped with the knowledge and skills required to excel in your surveying career and make a significant impact in the industry. Don't miss this opportunity to boost your career prospects - enrol now! This Surveying Diploma - Level 5 Bundle Package includes: Course 01: Diploma in Surveying Basics at QLS Level 5 10 Premium Additional CPD QS Accredited Courses - Course 01: Quantity Surveying Course Course 02: Land Surveying Course 03: Building Quantity Surveying Course 04: The Role of a Residential Surveyor Course 05: Site Management Course 06: Site Management Safety Training Course 07: Diploma in Construction Industry Scheme (CIS) Course 08: Introduction to Xactimate: Construction Cost Estimation Course 09: Construction Estimation using RSMeans Course Course 10: Risk Assessment Why Prefer This Surveying Diploma - Level 5 Bundle? You will receive a completely free certificate from the Quality Licence Scheme. Option to purchase 10 additional certificates accredited by CPD. Get a free Student ID Card - (£10 postal charges will be applicable for international delivery). Free assessments and immediate success results. 24/7 Tutor Support. After taking this Surveying Diploma - Level 5 bundle courses, you will be able to learn: Gain a comprehensive understanding of surveying principles and practices. Learn how to manage construction sites effectively. Learn about safety measures and risk assessment in construction. Develop skills in construction cost estimation using Xactimate and RSMeans. Acquire knowledge of land and building surveying techniques. Learn how to become a successful residential surveyor. Enhance your skills and knowledge in quantity surveying. ***Curriculum breakdown of Basics of Surveying*** Module 01: Basics of Surveying Module 02: Tools and Techniques of Surveying Module 03: Surveying Instrumentation Module 04: Area Measurement Module 05: Measurement Volumes Module 06: Levelling Module 07: Contouring Module 08: Distance Measurement Module 09: Angles and Directions Module 10: Error and Uncertainty Module 11: Survey Report How is the Surveying Diploma - Level 5 Bundle Assessment Process? You have to complete the assignment questions given at the end of the course and score a minimum of 60% to pass each exam. Our expert trainers will assess your assignment and give you feedback after you submit the assignment. You will be entitled to claim a certificate endorsed by the Quality Licence Scheme after you successfully pass the exams. CPD 250 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This course bundle is ideal for: Budding surveyors looking to start their career in surveying. Experienced surveyors looking to expand their skillset. Individuals seeking to enter the construction industry. Anyone looking to progress in their surveying career. Career path Our courses will prepare you for a range of careers, including: Junior Surveyor - £22k - £28k per annum Surveyor - £28k - £40k per annum Senior Surveyor - £40k - £60k per annum Commercial Manager - £45k - £85k per annum Project Manager - £45k - £80k per annum Director of Surveying - £80k - £120k+ per annum Certificates Diploma in Surveying Basics at QLS Level 5 Hard copy certificate - Included After successfully completing the course, you can order an original hardcopy Certificate of Achievement endorsed by the Quality Licence Scheme. This certificate will be delivered to your home, free of charge. To obtain the additional Quality Licence Scheme Endorsed Certificate, you will need to pay the corresponding fee based on the level of the courses: Level 1: £59 Level 2: £79 Level 3: £89 Level 4: £99 Level 5: £119 Level 6: £129 Level 7: £139 CPD QS Accredited Certificate Digital certificate - £10 Upon successfully completing the Bundle, you will need to place an order to receive a PDF Certificate for each course within the bundle. These certificates serve as proof of your newly acquired skills, accredited by CPD QS and will cost you £10 for each course. Also, the certificates are recognised throughout the UK and internationally. CPD QS Accredited Certificate Hard copy certificate - £29 International students are subject to a £10 delivery fee for their orders, based on their location.

This Diploma in Safeguarding Children at QLS Level 5 course is endorsed by The Quality Licence Scheme and accredited by CPDQS (with 150 CPD points) to make your skill development & career progression more accessible than ever! ou have been working as a teacher for a few years and you are concerned about the wellbeing of some of your students. You want to gain the knowledge and skills to identify and respond to child abuse and neglect. The Safeguarding Children at QLS Level 5 course can provide you with the necessary training to ensure the safety and protection of the children under your care. Are you looking for a course that can help you protect children from harm? The Safeguarding Children at QLS Level 5 is an essential course for anyone who works with children. It covers laws, guidance, and risk assessment, as well as responding to disclosure and reporting. You will also learn about child abuse, sexual abuse, and the impact of domestic violence on children. The course will equip you with the skills and knowledge to provide early help and support to children and their families. By completing this course, you will develop a deep understanding of the social and emotional development of children, as well as their personality and intellectual development. You will learn about the importance of infant mental health and early attachment and how to assess need and provide early help. You will also gain the skills to safeguard trafficked children and respond appropriately to disclosures of abuse or neglect. After this course, you will be able to learn: Understand laws and guidance related to safeguarding children Identify risks and assess them appropriately Respond effectively to disclosure of abuse or neglect Recognise the impact of domestic violence and abuse on children Provide early help and support to children and families Safeguard trafficked children and vulnerable young people Why Prefer This Safeguarding Children at QLS Level 5 Course? Opportunity to earn a certificate endorsed by the Quality Licence Scheme & another accredited by CPDQS which is completely free. Get a free student ID card! (£10 postal charge will be applicable for international delivery) Innovative and engaging content. Free assessments 24/7 tutor support. Take a step toward a brighter future! *** Course Curriculum *** Here is the curriculum breakdown of the Safeguarding Children at QLS Level 5 course: Module 01: Laws and Guidance Module 02: Social and Emotional Development Module 03: Personality and Intellectual Development of Children Module 04: Child Abuse Module 05: Sexual Abuse Module 06: The Impact of Domestic Violence and Abuse on Children Module 07: Risks and Risk Assessment Module 08: Responding to Disclosure and Reporting Module 09: Things to Do after Referral Module 10: Safeguarding Trafficked Children Module 11: Infant Mental Health and Early Attachment Module 12: Assessing Need and Providing Early Help Assessment Process You have to complete the assignment questions given at the end of the course and score a minimum of 60% to pass each exam. Our expert trainers will assess your assignment and give you feedback after you submit the assignment. You will be entitled to claim a certificate endorsed by the Quality Licence Scheme after you have completed all of the Diploma in Safeguarding Children at QLS Level 5 exams. CPD 150 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This Safeguarding Children course is for: Teachers, teaching assistants, and childcare providers Social workers and other child protection professionals Healthcare workers, including doctors and nurses Youth workers and volunteers Police officers and law enforcement personnel Anyone who works with or around children Requirements No prior background or expertise is required. Career path The Safeguarding Children course will boost your CV and aims to help you get the job or even the long-awaited promotion of your dreams. Like as: Child Protection Social Worker: Avg. Salary £35,000 Childcare Manager: Avg. Salary £28,000 Youth Worker: Avg. Salary £21,000 Police Officer: Avg. Salary £24,000 Early Years Practitioner: Avg. Salary £17,000 School Counsellor: Avg. Salary £25,000 Certificates CPDQS Accredited Certificate Digital certificate - Included Diploma in Safeguarding Children at QLS Level 5 Hard copy certificate - Included Show off Your New Skills with a Certificate of Completion After successfully completing the Diploma in Safeguarding Children at QLS Level 5, you can order an original hardcopy certificate of achievement endorsed by the Quality Licence Scheme and also you can order CPDQS Accredited Certificate that is recognised all over the UK and also internationally. The certificates will be home-delivered, completely free of cost.

Child Protection Course This Child Protection Course is designed to equip you with the essential knowledge and skills needed to become an expert in child care and risk assessment. This course will give you all the practical knowledge & credentials that you need to excel in your new role. Our Child Protection course will give you a broad grasp of the subject. The course provides specific modules that break down each topic and guarantee that all of our students have an outstanding and complete learning experience. Why Choose Child Protection Course from Us Self-paced course, access available from anywhere. Easy to understand, high-quality study materials. Course developed by industry experts. Automated and instant assessment results. 24/7 support via live chat, phone call or email. Free PDF certificate as soon as completing the course. Courses We Offer Course 01: Child Protection Course Course 02: Level 4 Diploma in Child Psychology Child Protection Course The course will also educate you about different types of child abuse, risk identification, and assessing children's needs, among other things. You will also be taught how to properly illustrate the policies. After finishing the course, you will receive a professional certificate and learn from industry professionals. Learning Outcomes After completing this Child Protection course, you will be able to: Describe the fundamentals of child protection and risk assessment. Know the UK laws & legislation of child protection. Identify and prevent different types of child abuse. Explain risk assessment. Know about initial decision making. Prepare a child protection record. Certificate of Completion You will receive a course completion certificate for free as soon as you complete the Child Protection Course. Child Protection Course 49:00 1: Child Protection Course 49:00 PDF Level 4 Diploma in Child Psychology 2:14:00 2: Level 4 Diploma in Child Psychology 2:14:00 PDF Who is this course for? Child Protection Course This Child Protection course is for anyone who enjoys learning new skills. Requirements Child Protection Course There are no specific requirements for Child Protection course because it does not require any advanced knowledge or skills. Students who intend to enrol in Child Protection course must meet the following requirements: Good command of the English language Must be vivacious and self-driven Basic computer knowledge A minimum of 16 years of age is required Career path Child Protection Course This Child Protection course will assist you in obtaining a job in the relevant field and advancing your career. After completing this course, you will be able to pursue a variety of job opportunities. This also improves your ability to be considered for job promotions. Certificates Reed Courses Certificate of Completion Digital certificate - Included Will be downloadable when all lectures have been completed.

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