Management of Value (MoV®) Foundation This interactive MoV® Foundation course provides a modular and case-study-driven approach to learning Management of Value (MoV). The core knowledge is structured and comprehensive; and well-rounded modules cover the methodology and various techniques. A case study is used to help appreciate the relevance of MoV in its practical application. What you will Learn Upon completion of an MoV course candidates should be able to discuss and explain: The main processes and techniques used within MoV and the reasons for using them How MoV may be applied at portfolio, program, project and operational levels The differences in applying MoV at different stages in a project and the expected outputs from a MoV Study at each stage The circumstances under which MoV should be used The concept of value and how value may be improved The main benefits arising from the use of MoV Approaches for implementing MoV How to respond to external and internal influences The principles of embedding MoV into an organization The key topics in document checklists, the toolbox, health check, organizational maturity and individual competence. Upon successful completion of this course, you will be able to: Organize and contribute constructively to a Management of Value (MoV) Study Demonstrate a knowledge of MoV principles, processes, approach and environment Analyse a company, program or project to establish its organizational value; includes identification and weighting of Value Drivers Pass the AXELOS MoV Foundation Examination Introduction to value management and MoV Value and Value Management Capabilities, Outcomes, Benefits and Disbenefits What is Value? What is Management of Value (MoV)? Why use MoV? Where use MoV? When MoV should be used? What using MoV involve? Selected MoV benefits Relationship with other AXELOS Global Best Practices and Models How MoV fits with other AXELOS Global Best Practice Guides MoV principles Align with organization's objectives Focus on functions and required outcomes Balance the variables to maximise value Apply throughout the investment decision Tailor MoV to suit the subject Learn from experience and improve Assign clear roles and responsibilities and build a supportive culture MoV processes Frame the programme or project Gather information Analyse information Process information Evaluate and select Develop Value Improving Proposals Implement and share outputs MoV techniques Function Analysis Function Analysis System Technique (FAST) Traditional (or classic) FAST Technical FAST Customer FAST Value Trees Measuring value Value profiling (a.k.a. value benchmarking) Simple multi-attribute rating technique (a.k.a. SMART) Value index Value metrics Value for money (VfM) ratio Value Engineering / Analysis Common techniques used in MoV Analysis of information Benchmarking Process Mapping Root Cause Analysis Discounted Cash Flow Analysis Generating Ideas Brainstorming Evaluation and option selection Option Selection Matrix Idea selection Allocation to Categories Idea Selection Matrix Weighting techniques Paired Comparisons Points Distribution Developing VIPs Developing Proposals Cost Benefit Analysis Building Decisions Implementing VIPs Implementation Plans Feedback Following up Tracking Benefits Approach to Implementation Generic approach to MoV implementation Plan the MoV activities Understand and articulate value Prioritize value Improve value Quantify value Monitor improvements in value Learn lessons Environmental factors Portfolio Considerations Programme considerations Project considerations Operational Considerations Embedding MoV into an organization Benefits of Embedding MoV into an organization MoV Policy MoV Policy Composition Embedding MoV into an organisation Key steps Suggested MoV Management Structure Overcoming barriers We do it anyway It takes up too much time We can't afford to make the changes What's in it for me? Don't fix it if it ain't broke Fixed returns on investment MoV products Briefing Meeting Agenda (A.1) Communications Checklist (A.2) Equipment list for an Effective Study/Workshop (A.3) Invitation to join the Study Team (A.4) Option Evaluation Matrix (A.5) Plan the Study (A.6) Recording Idea Selection (A.7) Reporting Study outputs (A.8) Scoping the Study (A.9) Study or Workshop Handbook (A.10) Value-Improvement Proposal Forms (A.11) Value Improvement Tracking Report (A.12) MoV toolbox MoV health check and maturity model P3M3 Maturity Model MoV Maturity Model (aligned with P3M3)
We communicate daily in many ways, including email, phone, text, Zoom, Teams, Google Meets, Slack, and even that old-fashioned thing, what was it now... oh yes, talking face-to-face. But, when we look at communication closely and really drill down into what we are doing in conjunction with how our brain works (neuroscience), how internal, organisational, and social politics control what we believe we can say, how hierarchical positioning impacts our honesty and how the lack of psychological safety means we say what we know others want to hear rather than what they need to hear…. It is oh so complicated! This workshop not only explores the concept of excellent communication, but we also want to hear what you believe it is too. We also delve into how organisational culture influences our perception of speaking up. Factors that hinder open and honest communication, and we work collaboratively towards removing these barriers to achieve a communication style that fosters trust and transparency, creating psychological safety. This workshop is particularly relevant to our Emotional Intelligence workshop (EI and Me). We firmly believe that developing emotional intelligence is the key to unlocking Clean Communication, a skill that is crucial for all of us, regardless of our roles and responsibilities, so that we thrive in our professional environment. If you want to see if we are correct, why not have us facilitate a workshop for you and see what you get by the end of it? LENGTH - Normally, one day. But please contact us to discuss your specific needs, or we can offer advice. NEXT WORKSHOP START - Please ask for more information as we deliver bespoke closed events for your people at your location or a mutually suitable location. WORKSHOP DELIVERY - The best environment for this workshop is face-to-face, but we can facilitate this workshop online. Suitability - Who should attend? Who Should Attend and Why? Who? - Perhaps think of this another way… who shouldn’t attend to ensure we can attain Clean Communication? There’s your answer. Why? - Every person needs to understand what we are saying above about how we get trapped in this organisational formatting which changes how we communicate and how it prevents us from communicating cleanly. EVERY organisation has this, despite what our values profess. And 'Values', that’s a whole other story. Workshop Content Using the 'Moccasin Approach'® to clean our personal and organisational communication LaPD’s Communication Cycle and what we must consider. (Can you work out what the ? represent above? Accountability and Responsibility raises its head in Communication. It has to. Bias, unconscious bias and its impacts on our communication. The conundrum of communicating with others and their styles (The TRAP). How would my perfect Manager/Leader communicate with me? Nonverbal communication (body language), rapport, Clean Communication. Negative communication can go viral (Self-Fulfilling Prophecy). Reflections, findings and goals (individual and team). Meeting our workshop objectives by listing five areas for development. Workshop delivery and venue This workshop is usually one day in duration, and it focuses solely on how we communicate with each other. It can also be a two-day event incorporating aspects of Emotional Intelligence (EI) with group, and individual activities to allow discussions about the various communication we need in your organisation. When you consider the content we deliver, we are sure you will understand why we always prefer to deliver our workshops, courses and programmes face-to-face. Face-to-face workshops and courses can be held at a location of your choice or, if you wish, a central UK location, such as the Macdonald Burlington Hotel in Birmingham, located directly across from the Birmingham New Street train station. We can deliver our workshops, courses and programmes online, although this will mean splitting elements into manageable learning events to suit the online environment.
DASA DevOps Professional: Enable and Scale: In-House Training DevOps embodies both cultural changes and practices through which organizations can facilitate the IT functions of software development (Dev) and software operation (Ops). The DevOps movement advocates automation and phase-based monitoring practices. Its objectives include: Decreasing development cycles · Increasing deployment frequency Improving the reliability of releases Developing a closer alignment with business objectives The DASA DevOps Professional: Enable and Scale course (formerly known as DevOps Practitioner) is designed to provide individuals with the core education necessary to put DevOps into practice. With the help of DevOps theory, pragmatic examples and exercises, and interactive group discussions, the course will help you understand how to apply the necessary skills to practice DevOps. Building on the knowledge learned on theFundamentals course (the 'why'), you will learn the 'how'. The DevOps Professional: Enable and Scale course focuses on improving the skill set of the DASA competency model, which includes competencies like Courage, Teambuilding, DevOps Leadership, and Continuous Improvement. On completion of the DASA DevOps Professional: Enable and Scale training and passing the exam, the certification is awarded. What you will Learn At the end of this program, you will be able to: Explain the importance of DevOps culture and the aspects that can influence it Explain why courage, teambuilding, leadership, and continuous improvement are required in a DevOps environment Explain why courage is essential to enable trust, honesty, and experimentation Identify and evaluate different types of behavior in a DevOps environment Recognize the signals indicating impediments and/or team dysfunctions Describe how to form good DevOps teams and assess their maturity List the effects of happiness and motivation on team performance Identify how leaders encourage feedback and transparency Discuss the factors that leaders can influence to build trust Explain how and why leaders promote a 'safe to fail' environment Analyze value streams to improve throughput and flow Facilitate the tools for continuous improvement: structured problem-solving workshops, Story Mapping sessions, and retrospectives TEAMBUILDING Teambuilding is about understanding the other's point of view, collaboration, mutual accountability, common purpose, and the ability to integrally support the service/product. Design Teams Characteristics of a DevOps team Skills of a DevOps Team Self-organization and autonomy Rules to consider when designing DevOps teams Build Teams Effects of happiness and motivation on performance Feedback Creating high-performance teams Governance Governance within teams and between multiple teams Governance between organizations DevOps contracts DEVOPS LEADERSHIP This module describes how to facilitate teams to high performance, DevOps behavior, transparency, and a service lifecycle mindset. Build Culture Creating the right environment and providing vision and purpose Stimulating the right behavior Servant leadership: giving control, supporting, and inspiring Create Purpose Defining and aligning purpose Purpose of having a purpose Alignment versus autonomy Be a Servant Leader Give control to the team Inspire and support the team Focus on Success Output versus outcome Measuring and steering COURAGE The Courage module is about coaching courageous behavior, proactivity, reflection, trust, open discussions, experimentation, fail fast, and the courage to change. Build Courage The importance of courage Courage in relationship with leadership and feedback Enabling courage at the team level Dealing with failure Think Different Courage day to day Encourage critical thinking Techniques to promote courageous behavior VALUE CUSTOMER-CENTRIC ACTION This module describes the important aspects that are relevant to identify and deliver the required and expected value for all relevant stakeholders. Aspects of Value and Managing Expectations The different aspects of value Stakeholder management Customer collaboration and using customer feedback How to do prioritization CONTINUOUS IMPROVEMENT Continuous improvement describes the importance of a Kaizen mindset, quality at the source, first time right, knowledge-sharing, and the ability to adapt. Build Flow Understanding the importance of flow Using Lean to optimize flow Kaizen as a mindset Radical change versus Kaizen Using Pull to optimize flow Continuous Improvement Tools Kaizen Event Value Stream Mapping Visual Management Retrospective Daily Standup Five Times Why
DASA DevOps Professional: Enable and Scale DevOps embodies both cultural changes and practices through which organizations can facilitate the IT functions of software development (Dev) and software operation (Ops). The DevOps movement advocates automation and phase-based monitoring practices. Its objectives include: Decreasing development cycles · Increasing deployment frequency Improving the reliability of releases Developing a closer alignment with business objectives The DASA DevOps Professional: Enable and Scale course (formerly known as DevOps Practitioner) is designed to provide individuals with the core education necessary to put DevOps into practice. With the help of DevOps theory, pragmatic examples and exercises, and interactive group discussions, the course will help you understand how to apply the necessary skills to practice DevOps. Building on the knowledge learned on theFundamentals course (the 'why'), you will learn the 'how'. The DevOps Professional: Enable and Scale course focuses on improving the skill set of the DASA competency model, which includes competencies like Courage, Teambuilding, DevOps Leadership, and Continuous Improvement. On completion of the DASA DevOps Professional: Enable and Scale training and passing the exam, the certification is awarded. What you will Learn At the end of this program, you will be able to: Explain the importance of DevOps culture and the aspects that can influence it Explain why courage, teambuilding, leadership, and continuous improvement are required in a DevOps environment Explain why courage is essential to enable trust, honesty, and experimentation Identify and evaluate different types of behavior in a DevOps environment Recognize the signals indicating impediments and/or team dysfunctions Describe how to form good DevOps teams and assess their maturity List the effects of happiness and motivation on team performance Identify how leaders encourage feedback and transparency Discuss the factors that leaders can influence to build trust Explain how and why leaders promote a 'safe to fail' environment Analyze value streams to improve throughput and flow Facilitate the tools for continuous improvement: structured problem-solving workshops, Story Mapping sessions, and retrospectives TEAMBUILDING Teambuilding is about understanding the other's point of view, collaboration, mutual accountability, common purpose, and the ability to integrally support the service/product. Design Teams Characteristics of a DevOps team Skills of a DevOps Team Self-organization and autonomy Rules to consider when designing DevOps teams Build Teams Effects of happiness and motivation on performance Feedback Creating high-performance teams Governance Governance within teams and between multiple teams Governance between organizations DevOps contracts DEVOPS LEADERSHIP This module describes how to facilitate teams to high performance, DevOps behavior, transparency, and a service lifecycle mindset. Build Culture Creating the right environment and providing vision and purpose Stimulating the right behavior Servant leadership: giving control, supporting, and inspiring Create Purpose Defining and aligning purpose Purpose of having a purpose Alignment versus autonomy Be a Servant Leader Give control to the team Inspire and support the team Focus on Success Output versus outcome Measuring and steering COURAGE The Courage module is about coaching courageous behavior, proactivity, reflection, trust, open discussions, experimentation, fail fast, and the courage to change. Build Courage The importance of courage Courage in relationship with leadership and feedback Enabling courage at the team level Dealing with failure Think Different Courage day to day Encourage critical thinking Techniques to promote courageous behavior VALUE CUSTOMER-CENTRIC ACTION This module describes the important aspects that are relevant to identify and deliver the required and expected value for all relevant stakeholders. Aspects of Value and Managing Expectations The different aspects of value Stakeholder management Customer collaboration and using customer feedback How to do prioritization CONTINUOUS IMPROVEMENT Continuous improvement describes the importance of a Kaizen mindset, quality at the source, first time right, knowledge-sharing, and the ability to adapt. Build Flow Understanding the importance of flow Using Lean to optimize flow Kaizen as a mindset Radical change versus Kaizen Using Pull to optimize flow Continuous Improvement Tools Kaizen Event Value Stream Mapping Visual Management Retrospective Daily Standup Five Times Why
Duration 2 Days 12 CPD hours This course is intended for The target audience for the CASM course is Anyone interested in learning about Agile and Scrum from a products and process perspective Process owners and process designers Developers who are interested in helping make processes more agile Managers who are looking to bridge multiple practices into a DevOps environment Employees and managers responsible for designing, re-engineering or improving process Consultants guiding their clients through process improvement and DevOps initiatives Internal and external suppliers Process stakeholders Overview The learning objectives for Certified Agile Service Manager (CASM) include an understanding of: What does it mean to 'be agile?' The Agile Manifesto, its core values, and principles Agile concepts and practices including ITSM, Kanban, Lean and DevOps Learn about SCRUM from a product and process perspective Agile thinking and values into service management Scrum roles, artifacts, and events as it applies to both products and processes The two aspects of Agile Service Management: Agile Process Improvement-ensuring processes are lean and deliver 'just enough' control Agile Process Design-applying Agile practices to process design projects This course provides an introduction to Agile Service Management, the application, and integration of agile thinking into service management processes and process design projects. Agile thinking improves IT?s effectiveness and efficiency and enables IT to continue to deliver value in the face of changing requirements. This course prepares you for the Certified Agile Service Manager (CASM) certification. Why Agile Service Management? Challenges Today What is IT Service Management? What is Agile? Agile Manifesto and Principles What Does It Take To Be Agile? Agile Service Management What is Agile Service Management? Agile Service Management Goals, Objectives and Benefits Two Aspects: Agile Process Engineering & Agile Process Improvement Leveraging Related Guidance DevOps ITIL Site Reliability Engineering Lean Scrum Agile Service Management Roles Relationship to Scrum roles Agile Practice Owner Agile Service Management Team Agile Service Manager Agile Process Engineering Agile Processes How Processes Deliver Value Waterfall vs Agile Process Engineering Relationship to Scrum Events & Artifacts Minimum Viable Process Microprocess Architectures Service Management Architecture Agile Service Management Artifacts Practice Backlog Spring Backlog Increment Agile Service Management Events Planning The Sprint Sprint Planning Process Standups Sprint Review Sprint Retrospective Agile Process Improvement Why Process Improvement is Important Process Improvement Goals Process Improvement Reviews Sustaining Improvements Automation
Better Business Cases™ Foundation: Virtual In-House Training Better Business Cases™ is based on the Five Case Model - which is the UK government's best practice approach to structuring spending proposals and making effective business decisions. Using this best practice approach will allow organizations to reduce unnecessary spending and improve the decision-making process which gives you a greater chance of securing necessary funding and support for initiatives. The goal of the foundation course is to enable participants to work effectively with a team to develop a strong business case in their work environment. What You Will Learn At the end of this program, you will be able to: Describe the philosophy and the underlying rationale of the Five Case Model Identify different types of business case, their purpose, who is responsible for them Recognize when the different types are required in the development of a spending proposal Develop the business case in relation to other recognized and recommended best practices for programme and project management Overview of the Five Case Model Five key components of a business case and the order in which they are presented Three key stages in the development of a spending proposal Definition of a programme / project and the key differences between programmes and projects Purpose of a Business Justification Case (BJC) and in what circumstances it should be considered Purpose of a Strategic Outline Case (SOC) Purpose of an Outline Business Case (OBC) Purpose of a Full Business Case (FBC) Relationship between policies, strategies, programmes, and projects and their deliverables Developing the Strategic Case Purpose and core content of a Strategic Case Purpose of SMART robust spending objectives and the key objectives for spend: economy, efficiency, effectiveness, re-procurement, and statutory or regulatory compliance Four main categories of benefits criteria and the parties involved in their development Three key categories of risk Purpose of identifying constraints and dependencies Difference between direct and indirect benefits Developing the Economic Case Purpose and core content of an Economic Case Purpose of critical success factors and the key critical success factors based upon the Five Case Model Purpose of the long list options and how to generate options and undertake SWOT analysis Minimum of four short-list options, how they are derived, and what they should include (Reference Project / Public Sector Comparator [PSC]) Difference between the preferred way forward and the preferred option Purpose, objectives, key participants, and outputs of Workshop Stage 2 - identifying and assessing the options Rules that should be followed for the treatment of costs and benefits Key differences between economic appraisals and financial appraisals Factors considered when selecting the preferred option Developing the Commercial Case Purpose and core content of a Commercial Case Guiding principles when apportioning risk between the contractual parties Purpose of payment mechanisms Purpose of Step 9 in the development framework: Contracting for the deal Developing the Financial Case Purpose and core content of a Financial Case The financial statements required for all projects The possible impacts to consider Developing the Management Case Purpose and core content of a Management Case Purpose of a programme / project management strategy, framework, and plan Purpose of a change management strategy, framework, and plan Purpose of a benefits realization strategy, framework, and register / plan Purpose of a risk management strategy, framework and register / plan Purpose of a post programme / project evaluation strategy, framework, and plan
Management of Portfolios (MoP®) Foundation: Virtual In-House Training In this MoP® Foundation course, participants will acquire the sufficient knowledge and understanding of the principles, cycles, practices, techniques, roles, responsibilities, documents, and organizational context within which portfolio management operates. MoP helps organizations ensure if the investments are done in the right change initiatives and implementing them correctly. This is achieved by: Prioritizing the programs and projects in terms of their contribution to the organization's strategic objectives and overall level of risk Managing the programs and projects consistently to ensure efficient and effective delivery Maximizing the benefit by providing the greatest return from the investment made What You Will Learn Individuals certified at the MoP Foundation level will be able to: Define the scope and objectives of portfolio management and how it differs from program and project management List the benefits of applying portfolio management Explain the context it operates in List the principles upon which successful portfolio management is based on List the different approaches to implement MoP List the factors required to maintain the progress and assess the success of portfolio management State the purpose and key content of the major portfolio documents Define the scope of key portfolio management roles Introduction: MoP Scenario Background of the Methodology The MoP Principles Senior Management Commitment Governance Alignment Strategy Alignment Portfolio Office Energized Change Culture The MoP Definition Cycle Roles and Responsibilities The MoP Delivery Cycle Management control Benefits management Financial management Risk management Stakeholder engagement Organizational governance Resource management The MoP Framework Recap
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