1258 Courses

This GRI, IEMA & CPD course is geared for busy professionals who want to understand how to proceed and create a 1st Class GRI Standards Sustainability Report and have a plan for immediate sustainability action without wasting time.

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

Cloud technologies training course description This course provides an introduction to cloud technologies, including, configuration and deployment, security, maintenance, and management. It covers all aspects of cloud computing infrastructure. It will help you to master the fundamental concepts, terminology, and characteristics of cloud computing. . What will you learn Contrast and compare AWS, GCP and Azure. Explain the different cloud services, models and characteristics. Explain cloud virtualization components and options. Explain cloud security options. Describe cloud automation, orchestration, monitoring and performance options. Cloud technologies training course details Who will benefit: Anyone working with or looking to work with cloud technologies. Prerequisites: None. Duration 2 days Cloud technologies training course contents What is the cloud? The Internet Cloud computing Benefits Disadvantages Cloud services IaaS, PaaS, SaaS, others. Cloud service providers AWS, GCP Microsoft Azure, others Cloud architectures Private, public, hybrid others Cloud based delivery The cloud and virtualization Virtual Machines, networks, storage, deployment. Accessing the Virtual Machine Secure cloud environments Security considerations. Data privacy considerations Automation and orchestration Monitoring and performance Performance Cost issues Cost containment

Advanced Kibana training course description This training course is aimed at users who already have some experience with Kibana, who are looking to further their knowledge. What will you learn Lens Timelion Maps Custom Visualisations with Vega Canvas Filters and Controls Drilldown and Dashboards KQSL and ElasticQueries Scripted and RunTime Fields Alerts and Alarms Advanced Kibana training course details Who will benefit: Users who already have some experience with Kibana, who are looking to further their knowledge. Prerequisites: None Duration 1 day Advanced Kibana training course contents Topics Lens Visualisation types (tables,bars,charts) Category breakdown Adding multiple metrics Using formulas in metrics Labels Adding reference layer Limitations Visualise Library Timeseries, Metrics Different types of aggregations Maps GeoMapping Heat Maps Using ES index as data source Visualisation, tool tips Custom Visualisations with Vega Introduction to vega scripting Canvas Widgets and Texts Elasticsearch SQL Canvas Expressions Filters and Controls Dropdown filters Ad-hoc filters Searchbar filters Drilldown Dashboards Linking one dashboard to another KQSL and ElasticQueries Bool Query AND/OR Phrase Part match vs keyword search Wildcard search Scripted and RunTime Fields Creating ad-hoc calculated fields using scripts Performance issues Alerts and Alarms Query Based Formatting output Connector types(email,index,teams etc)

Linux shell scripting training course description A practical introduction to writing scripts using the Bourne shell under any Linux operating system. Applicable for those using the Korn shell as well. What will you learn Read shell scripts. Write shell scripts. Use different types of quotes. Recognise the role of shell scripts within the Linux system. Linux shell scripting training course details Who will benefit: Programmers developing programs under UNIX. Administrators / support personnel who wish to find out more about the workings of Linux or write simple utility programs. Prerequisites: Linux Fundamentals Duration 2 days Linux shell scripting training course contents Review of Linux fundamentals Basic shell scripts What does the shell do? How are commands executed? Different shells. what is a shell script? Comments, creating shell scripts. Variables Setting variables, using variables, set, scope, export, sourcing, environmental variables, read. Positional parameters $0 to $9, $#, $* and others. shift parameter substitution. Control statements The test command The if statement while loops for loops The case statement. Special characters Redirection of errors, here documents, quoting. Arithmetic in shell scripts The expr command. System shell scripts Screen handling The terminfo database, The tput command. Advanced issues (optional session) Shell functions, getopts, xargs, debugging shell scripts, portability issues. Extras in the Korn shell. Optimising shell scripts The time command, performance tips.

APM Project Fundamentals Qualification (PFQ): In-House Training This practical course gives Participants a solid introduction to the fundamentals of project management and to prepare them for the one-hour, multiple-choice exam held at the end of the course. The APM Project Fundamentals Qualification (PFQ) is an entry-level qualification suitable for those who are new to project management and working in a project team, and who wish to understand the standard terminology. The goal of this course is to prepare you to successfully pass the exam. What you will Learn You'll learn how to: Identify project management terminology and context Identify project management processes Identify the roles involved in project management Describe project success criteria and benefits Prepare project documentation Acquire the level of understanding needed to pass the APM PFQ examination Getting Started Introductions Course structure Course goals and objective Project Context Project characteristics Project management processes Business and project context Organizational roles Project Lifecycle Programme and portfolio management Project Concept Phase Stakeholder management Project success and benefits management Business case Benefits People in Projects Leadership and teamwork Communication Project Definition Phase Project management plan Quality management Risk management Scope management Scheduling Resource management Estimating Procurement Project Implementation Phase Change control and configuration management Issue management Information management Project Hand-over and Close-out Phase Hand-over and close-out Post-project review Revision and Exam Revision and practice questions APM PFQ examination

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Management of Risk (M_o_R®) Foundation: In-House Training This M_o_R® Foundation course prepares learners to demonstrate knowledge and comprehension of the four elements of the M_o_R framework: Principles, Approach, Processes, Embedding and Reviewing and how these elements support corporate governance. The M_o_R Foundation Course is also a prerequisite for the M_o_R Practitioner qualification. What you will Learn At the end of the M_o_R Foundation course, participants will gain competencies in and be able to: Describe the key characteristics of risk and the benefits of risk management List the eight M_o_R Principles List and describe the use of the key M_o_R Approach documents Create Probability and Impact scales Define and distinguish between risks and issues Create a Risk Register Create a Stakeholder map Identify the key roles in risk management Use the key techniques and describe specialisms in risk management Undertake the M_o_R Foundation examination Introduction Introduction to the M_o_R course What is a risk? What is risk management? Why is risk management so important? Basic risk definitions The development of knowledge about risk management Corporate governance and internal control Where and when should risk management be applied? M_o_R Principles The purpose of M_o_R principles Aligns with objectives Fits the context Engages stakeholders Provides clear guidance Informs decision-making Facilitates continual improvement Creates a supportive culture Achieves measurable value Risk management maturity models M_o_R Approach Relationship between the documents Risk management policy Risk management process guide Risk management strategy Risk register Issue register Risk response plan Risk improvement plan Risk communications plan M_o_R Process Common process barriers Identify contexts Identify the risks Assess estimate Assess evaluate Plan Implement Communication throughout the process M_o_R Perspectives Strategic perspective Program perspective Project perspective Operational perspective Risk Specialisms Business continuity management Incident and crisis management Health and Safety management Financial risk management Environmental risk management Reputational risk management Contract risk management

Portfolio, Programme, and Project Offices (P3O®) Practitioner: In-House Training P3O® is the AXELOS standard for the design of decision-making processes regarding changes in organizations. P3O provides a guideline for the design of portfolio, programme, and project offices in organizations. The P3O Practitioner Course is an interactive learning experience. The P3O Practitioner-level content provides you with sufficient knowledge and understanding of the P3O guidance to design, implement, manage or work within any component office of a P3O model. It enables participants to successfully complete the associated P30 Practitioner exam and achieve the qualification. In this course, you will be prepared to successfully attempt the P3O Practitioner exam and learn how to implement or re-energize a P3O model in their own organization. What you will Learn At the end of the P3O Practitioner course, you will be able to: Define a business case to get senior management approval for P3O Build a right P3O model to adapt to the organization's needs, taking account of the organization's size and portfolio, programme and project management maturity Identify the elements, roles, and functions deployed in a generalized P3O model Use tools and techniques in running the P3O and advising those who shape the portfolio of programmes and projects Introduction to P3O What is the purpose of P3O? Definitions What are P3Os? Portfolio, programme, and project lifecycles Governance and the P3O Designing a P3O Model Factors that affect the design Design considerations What functions and services should the P3O offer? Roles and responsibilities Sizing and tailoring of the P3O model Why have a P3O? How a P3O adds value Maximizing that value Getting investment for the P3O Overcoming common barriers Timescales Why have a P3O (Extension)? The P3O Business Case The P3O Model Blueprint Vision Statement Demonstrating the Value KPIs The Benefits of Claimed Capabilities Benefit Realisation and Strategic Objectives Benefit Profile How to Implement or Re-Energize a P3O Implementation lifecycle for a permanent P3O Identify Define Deliver Close Implementation lifecycle for a temporary programme or project office Organizational context Definition and implementation Running Closing Recycling How to operate a P3O Overview of tools and techniques Benefits of using standard tools and techniques Critical success factors P3O tools P3O techniques

Management of Risk (M_o_R®) Practitioner: In-House Training The M_o_R® Practitioner course has been designed to provide learners with the opportunity to practice the practical application of the M_o_R method and covers the twelve M_o_R principles: Approach, Process and the basic techniques essential to managing risks using the M_o_R guidance. The purpose of the M_o_R Practitioner qualification is to confirm that the learner has achieved sufficient understanding of how to apply and tailor M_o_R in a scenario situation. What you will Learn At the end of the M_o_R Practitioner course, learners will gain competencies in: M_o_R framework (principles, approach based on risk documentation, process steps, and embedding and reviewing M_o_R principles Outline of M_o_R approach documents (including policy, process guide, and risk communications plan) Risk identification, assessment, and control Embedding and reviewing M_o_R M_o_R organizational perspectives (strategic, program, project, operational) Benefits The M_o_R Practitioner course offers a wide-ranging set of guidelines that will help in the management of risk in a project or program environment. It will help prepare learners for the M_o_R Practitioner Exam. They will feel more confident in approaching risk management after attending the course and will be aware of the use of different techniques that can assist in this task, including: Improved basis for effective strategy formation Reduced time spent fire-fighting and fewer unwelcome surprises Increased likelihood of successful change initiative outcomes Closer internal focus on doing the right things properly Increase in efficient use of resources waste and fraud Better management of contingency resources M_o_R roles and responsibilities M_o_R health check M_o_R maturity model Risk specialisms (including business continuity management) Introduction Introduction to the course What is a risk? What is risk management? Why is risk management so important? Basic risk definitions The development of knowledge about risk management Corporate governance and internal control Where and when should risk management be applied? M_o_R Principles The purpose of M_o_R principles Aligns with objectives Fits the context Engages stakeholders Provides clear guidance Informs decision-making Facilitates continual improvement Creates a supportive culture Achieves measurable value Risk management maturity models M_o_R Approach Relationship between the documents Risk management policy Risk management process guide Risk management strategy Risk register Issue register Risk response plan Risk improvement plan Risk communications plan M_o_R Process Common process barriers Identify - contexts Identify - the risks Assess - estimate Assess - evaluate Plan Implement Communication throughout the process M_o_R Perspectives Strategic perspective Programme perspective Project perspective Operational perspective Risk Specialisms Business continuity management Incident and crisis management Health and Safety management Financial risk management Environmental risk management Reputational risk management Contract risk management