Duration 2 Days 12 CPD hours This course is intended for Operations managers, account representatives, customer service staff, help desk and technical support, and anyone working directly with customer will benefit from this course. Overview Define customer service in relation to both internal and external customers Recognize how your attitude affects customer service Identify your customer\'s needs Generate repeat business with outstanding customer service Build goodwill through in-person customer service Provide outstanding customer service over the phone Connect with customers through online tools Deal effectively with difficult situations This course offers practical tools and techniques to win clients, create loyal advocates for your business, and deliver excellent customer service. Private classes on this topic are available. We can address your organization?s issues, time constraints, and save you money, too. Contact us to find out how. 1. Customer Service - A Baseline Recognizing Your Customers Understanding Your Role in Customer Service 2. Developing A Customer Service Mind-Set Leveraging Your First Impression Feeling Positively About Customers Mastering Moods and Emotions 3. Identifying Customer Needs Understanding the Customer\'s Situation Avoiding Assumption and Prejudgment Meeting Basic Needs Seeking to Exceeding Expectations Building Repeat Relationships 4. Connecting with the Customer Achieving Authenticity through Body Language Responding Effectively to Problems Mastering Online Etiquette Seeking Customer Feedback 5. Dealing with Difficult Situations Effectively Addressing Complaints De-escalating Anger Establishing Common Ground Remaining Calm, Respectful and Objective 6. Effectively Addressing Complaints Creating a Memorable Customer Experience Additional course details: Nexus Humans Providing Outstanding Customer Service training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the Providing Outstanding Customer Service course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.
Duration 2 Days 12 CPD hours This course is intended for Professionals who manage teams and desire to understand what leads to conflict, help peacefully navigate team members through potentially antagonistic situations, encourage and empower others to disagree respectfully and productively, and effectively manage disputes between team members will benefit from this course. Overview Identify and manage sources of conflict Define an effective strategy to deal with conflict Implement a process to manage conflict situations Build civility in the workplace In this course, students will learn to recognize the warning signs that precede quarrels and how to mitigate their impact, as well as constructive ways to harness the differences between team members and shift them toward productive, positive outcomes. Private classes on this topic are available. We can address your organization?s issues, time constraints, and save you money, too. Contact us to find out how. 1. Understanding conflict Identifying the Causes of Conflict Harnessing the Benefits of Conflict Resolving Conflict Understanding the Key People in Conflict Resolution 2. Civility in the Workplace Recognizing Uncivil Behavior Reaping the Benefits of Civil Behavior Working with Difficult People Identifying and Avoiding Incivility Creating, Implementing, and Enforcing a Civility Policy 3. Conflict Resolution Process Making an Effective Atmosphere Developing Mutual Understanding Focusing on individual and Shared Needs Getting to the Root Cause Generating Options Building a Solution 4. Conflict Resolution Strategies Differentiating Resolution Strategy Versus Process Recognizing the Advantages and Disadvantages to Collaborating, Competing, Compromising, and Avoiding Additional course details: Nexus Humans Constructive Conflict Management training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the Constructive Conflict Management course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.
Duration 2 Days 12 CPD hours This course is intended for Professionals desiring to be able to communicate clearly and concisely in their writing will benefit from this course. Overview Awareness of common spelling and grammar issues in business writing. Basic concepts in sentence and paragraph construction. Basic structure of agendas, email messages, business letters, business proposals, and business reports. Collaborative writing techniques, tools and best practices Tips and techniques to use when deciding the most appropriate format to use for agendas, email messages, business letters, business proposals, and business reports In this course, you will learn the essential skills needed to organize your thoughts and select the best words and phrases to clearly convey them in writing. Private classes on this topic are available. We can address your organization?s issues, time constraints, and save you money, too. Contact us to find out how. 1. Working With Words Monitoring Spelling, Grammar, and Verb Tense Creating a Reference Sheet 2. Constructing Sentences Recognizing Sentence Parts Classifying Sentence Type Increasing Readability with Punctuation 3. Creating Paragraphs The Three Basic Components Organization Methods 4. Finding Facts Identifying and Using Key Resources Fact-Finding and Information Gathering 5. Collaborative Writing Clarifying the Objective Collaborative Writing Strategies and Patterns 6. Types of Collaborative Business Writing Applying Different Construction Techniques Cut & Paste, Puzzle, Sequential Summative Integrating Construction 7. Collaborative Tools and Processes Planning and Revision Creating Outlines and Storyboards Building Team Cohesion 8. Writing Meeting Agendas Choosing an Agenda Format Structuring and Writing the Agenda 9. Writing E-Mails, Reports and Proposals Addressing Your Message Using Proper Grammar and Defining Acronyms Structuring, Formatting, and Writing Your Report Additional course details: Nexus Humans Writing for the Business Professional training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the Writing for the Business Professional course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.
Duration 2 Days 12 CPD hours This course is intended for The target audience for the DevSecOps Foundation course are professionals including: Anyone involved or interested in learning about DevSecOps strategies and automation Anyone involved in Continuous Delivery toolchain architectures Compliance Team Business managers Delivery Staff DevOps Engineers IT Managers IT Security Professionals, Practitioners, and Managers Maintenance and support staff Managed Service Providers Project & Product Managers Quality Assurance Teams Release Managers Scrum Masters Site Reliability Engineers Software Engineers Testers Overview You will learn: The purpose, benefits, concepts, and vocabulary of DevSecOps How DevOps security practices differ from other security approaches Business-driven security strategies and Best Practices Understanding and applying data and security sciences Integrating corporate stakeholders into DevSecOps Practices Enhancing communication between Dev, Sec, and Ops teams How DevSecOps roles fit with a DevOps culture and organization In this course, students will gain a solid understanding of how DevSecOps provides business value, enhancing your business opportunities, and improving corporate value. The core DevSecOps principles taught can support an organizational transformation, increase productivity, reduce risk, and optimize resource usage. This course explains how DevOps security practices differ from other approaches then delivers the education needed to apply changes to your organization. Participants learn the purpose, benefits, concepts, vocabulary and applications of DevSecOps. Most importantly, students learn how DevSecOps roles fit with a DevOps culture and organization. At the course?s end, participants will understand ?security as code? to make security and compliance value consumable as a service. This course prepares you for the DevSecOps Foundation (DSOF) certification. Realizing DevSecOps Outcomes Origins of DevOps Evolution of DevSecOps CALMS The Three Ways Defining the Cyberthreat Landscape What is the Cyber Threat Landscape? What is the threat? What do we protect from? What do we protect, and why? How do I talk to security? Building a Responsive DevSecOps Model Demonstrate Model Technical, business and human outcomes What?s being measured? Gating and thresholding Integrating DevSecOps Stakeholders The DevSecOps State of Mind The DevSecOps Stakeholders What?s at stake for who? Participating in the DevSecOps model Establishing DevSecOps Best Practices Start where you are Integrating people, process and technology and governance DevSecOps operating model Communication practices and boundaries Focusing on outcomes Best Practices to get Started The Three Ways Identifying target states Value stream-centric thinking DevOps Pipelines and Continuous Compliance The goal of a DevOps pipeline Why continuous compliance is important Archetypes and reference architectures Coordinating DevOps Pipeline construction DevSecOps tool categories, types and examples Learning Using Outcomes Security Training Options Training as Policy Experiential Learning Cross-Skilling The DevSecOps Collective Body of Knowledge Preparing for the DevSecOps Foundation certification exam Additional course details: Nexus Humans DevSecOps Foundation (DevOps Institute) training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the DevSecOps Foundation (DevOps Institute) course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.
ILM Level 3 Award in Effective Coaching – 5 day Accredited training course delivered in Nottingham 5 day course delivered in 5 x 1 day deliveries at one day per month. Ideal for those who are required to coach others within their organisation either as a line manager or where coaching forms part of their job role. Participants must have access to at least one coachee during the course to undertake a minimum of four hours of coaching outside of the course days
Duration 2 Days 12 CPD hours This course is intended for Professionals desiring to develop meaning engagement strategies to better connect with leadership, peers, and clients. JOB ROLES: Personal Development Leader of Teams/Projects Leader of Managers/Departments Leader of Organizational Strategy Overview Develop better strategies in preparation and execution with audiences of all kinds Engage audience members more deeply and intently Optimize ability to prepare delivery, style, and transparency in sharing information Deliver your message with more clarity, purpose, and passion Create deeper meaning in who you are as a leader for others What?s the difference between good engagement and incredible engagement? How do you know when your audience, employees, or teammates are committed to everything you say and do? The answer is Authentic Engagement. When you notice amazing leaders, you will notice they possess all seven of these traits, regardless of whether they have been in the profession twenty years or twenty weeks. This course is the map toward shaping the next wave of leaders, regardless of style, audience, or modality! The question is: Are you ready to embark on your voyage? In this course, you will learn how to authentically engage others, build a more purposeful message that resonates, and learn the strategies to gain stronger engagement and input back from the people you work with. Private classes on this topic are available. We can address your organization?s issues, time constraints, and save you money, too. Contact us to find out how. 1. The CYA Model of Preparation Preparing Your Content Learning the 4-Square to Holistic Content Delivery Getting Ready for the Seven C?s for Engagement Preparing for Yourself and Audience 2. Preparing Yourself and The Power of Your Delivery Understanding the Power of Delivery and Style Learning when to be Transparent in your Approach Understanding How You Shine Remotely vs. Face-to-Face Understanding Your Command Knowing What and When to Change Your Approach Building Better Efficacy and Confidence 3. Capturing, Building, and Connecting with the People You Engage Learning the Differences between Surface-Level Engagement and Deeper Connection Understanding the Four Levels of Audience to Build Relationships Developing Captivation Techniques with Engagement Establishing Clarity through Depth and Alignment Connecting Deeper and Establishing Trust 4. Going Beyond for Completeness Looking to the Future of Engagement, Technology, and Leadership Plotting Your Next Course for Delivery Using the Anchor Guide to Renew Your Approach Mapping the Next Steps Additional course details: Nexus Humans Mastering Meaningful Engagement training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the Mastering Meaningful Engagement course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.
Duration 2 Days 12 CPD hours This course is intended for The target audience for the DevOps Foundation course includes Management, Operations, Developers, QA and Testing professionals such as: Individuals involved in IT development IT operations or IT service management. Individuals who require an understanding of DevOps principles. IT professionals working within, or about to enter, an Agile Service Design Environment The following IT roles: Automation Architects, Application Developers, Business Analysts, Business Managers, Business Stakeholders, Change Agents, Consultants, DevOps Consultants, DevOps Engineers, Infrastructure Architect, Integration Specialists, IT Directors, IT Managers, IT Operations, IT Team Leaders, Lean Coaches, Network Administrators, Operations Managers, Project Managers, Release Engineers, Software Developers, Software Tester/QA, System Administrators, Systems Engineers, System Integrators, Tool Providers. Overview The learning objectives for DevOps Foundation include an understanding of: DevOps objectives and vocabulary Benefits to the business and IT Principles and practices including Continuous Integration, Continuous Delivery, testing, security and the Three Ways DevOps relationship to Agile, Lean and ITSM Improved workflows, communication and feedback loops Automation practices including deployment pipelines and DevOps toolchains Scaling DevOps for the enterprise Critical success factors and key performance indicators Real-life examples and results The DevOps Foundation course provides a baseline understanding of key DevOps terminology to ensure everyone is talking the same language and highlights the benefits of DevOps to support organizational success. Learners will gain an understanding of DevOps, the cultural and professional movement that stresses communication, collaboration, integration, and automation to improve the flow of work between software developers and IT operations professionals. This course prepares you for the DevOps Foundation (DOFD) certification. Exploring DevOps Defining DevOps Why Does DevOps Matter? Core DevOps Principles The Three Ways The First Way The Theory of Constraints The Second Way The Third Way Chaos Engineering Learning Organizations Key DevOps Practices Continuous Testing, Integration, Delivery, Deployment Site Reliability & Resilience Engineering DevSecOps ChatOps Kanban Business and Technology Frameworks Agile ITSM Lean Safety Culture Learning Organizations Continuous Funding Culture, Behaviors & Operating Models Defining Culture Cultural Debt Behavioral Models Organizational maturity models Automation & Architecting DevOps Toolchains CI/CD Cloud, Containers, and Microservices AI and Machine Learning Automation DevOps Toolchains Measurement, Metrics, and Reporting The Importance of Measurement DevOps Metrics - Speed, Quality, Stability, Culture Change lead/cycle time Value Driven Metrics Sharing, Shadowing and Evolving DevOps in the Enterprise Roles DevOps Leadership Organizational Considerations Getting Started Challenges, Risks, and Critical Success Factors Additional course details: Nexus Humans DevOps Foundation (DevOps Institute) training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the DevOps Foundation (DevOps Institute) course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.
Course Information Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. Apply risk management techniques to audit planning Plan and conduct computerised system audits Assess system validation documentation to verify compliance Evaluate data integrity and security issues Prepare for regulatory inspection. The course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Understand the vulnerabilities of computerised systems Learn how to create a compliance checklist Link system development with good business practice. Is this course for you? Auditors Audit programme managers Individuals subject to audits. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:45 Why We Validate and Regulatory Trends 10:30 Break 10:45 Audit Overview, High Level Process and Scheduling 11:30 System Lifecycle 12:30 Lunch 13:15 Exercise 1 - Audit Scheduling 14:45 Exercise 1 - Feedback 15:15 Break 15:30 Validation Deliverables 16:30 Risk Assessments 17:30 Close of Day 1 Day 2 09:00 Supplier Assessment 10:30 Break 10:45 Exercise 2 - Planning a Supplier Audit 12:00 Exercise 2 - Feedback 12:30 Lunch 13:15 Exercise 3 - Auditing a Computerised System Validation Package 15:30 Break 15:45 Exercise 3 - Feedback 16:30 Change Control 17:15 Close of Day Day 3 09:00 Infrastructure Qualification 09:45 Maintaining a Validated State - Operational Processes 11:00 Break 11:15 Exercise 4 - Auditing Systems in Operational Use 12:45 Lunch 13:30 Exercise 4 - Feedback 14:15 Exercise 5 - Auditing Trail Review 15:30 Break 15:45 Exercise 5 - Feedback 16:15 Course Objectives Summary and Any Additional Questions 16:45 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. 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. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote 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 19 Points Development Level Develop
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
Duration 2 Days 12 CPD hours This course is intended for Professionals who want to develop or strengthen their leadership position will benefit from this course. Overview Enhance your leadership effectiveness through your message Communicate with greater openness and authenticity Craft compelling messages that connect people to purpose Engage, motivate, and inspire others to embrace change Apply your leadership voice to increase your impact and influence Leaders inspire followership in others. Whether speaking conversationally or presenting before a group, a powerful leadership message delivered with impact and focused on the needs of the audience, can motivate and energize others. Private classes on this topic are available. We can address your organization?s issues, time constraints, and save you money, too. Contact us to find out how. 1. Leading with Authenticity Adopting a Structured Approach Linking Authenticity and Awareness Enhancing Self-Awareness Applying the Johari Window 2. Your Leadership Voice Becoming an Authentic Leader Assessing Key Competencies Defining Your Leadership Purpose 3. A Compelling Vision Crafting Your Vision for Change Clarifying Goals and Outcomes 4. Crafting Your Message Speaking with Credibility, Emotion, and Logic Leading from Anywhere Applying Techniques for Engaging Others Engaging Through Storytelling 5. Delivering Your Message Bridging Different Thinking Flexing Communication Styles Adjusting for Style and Impact 6. Reviewing Your Results Reviewing and Adjusting Taking an Iterative Approach Repeating, Reiterating, and Building Support