1537 A2 courses

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 Managers, directors, executives, and others responsible for leading teams, overseeing projects, and developing new leaders will benefit from this course. Overview Bring about valuable and positive change in those you lead Increase engagement, motivation and morale in your team Enhance performance of individuals and the team Provide an authentic role model that inspires followership Develop others into leaders This course will help students develop authentic leadership qualities that motivate and drive others to reach their full potential, and become the transformational leaders of the future. 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. DEFINING TRANSFORMATIONAL LEADERSHIP * Comparing Leadership Styles * Developing the Attitudes and Beliefs of a Transformational Leader 2. BEING AN AUTHENTIC LEADER * Knowing Who You Are * Fostering Authenticity and Credibility 3. DEMONSTRATING LEADERSHIP PRACTICE * Following the Five Practices of Exemplary Leadership 4. BUILDING ENGAGEMENT AND MOTIVATION * Understanding the Drivers of Employee Engagement * Motivating Like a Transformational Leader 5. OPTIMIZING PERFORMANCE * Coaching for Performance * Supporting Performance through Partnership * Unlocking Potential * Developing and Transforming Careers 6. MENTORING LEADERS * Growing Leaders * Putting Relationships First * Focusing on Character * Capitalizing on Strengths * Showing Optimism and Not Skepticism * Seeking Passion and Success 7. COMMITTING TO TRANSFORMATIONAL LEADERSHIP

Duration 5 Days 30 CPD hours This course is intended for This course is designed for individuals who have basic computer user skills and who are interested in obtaining a job as an entry-level IT technician. This course is also designed for students who are seeking the CompTIA A+ certification and who want to prepare for the CompTIA A+ Core 2 220-1102 Certification Exam. Overview Identify, install and configure Windows Operating System features Perform OS installations and upgrades Identify features and tools of macOS Identify features and tools of Linux OS Summarize security measures and protocols Configure SOHO network security Manage security settings Troubleshoot Windows OS problems Explain change-management best practices Implement workstation backup and recover methods Identify the basics of scripting CompTIA A+ certified professionals are proven problem solvers. They support today?s core technologies from security to cloud to data management and more. CompTIA A+ is the industry standard for launching IT careers into today?s digital world. It is the only industry recognized credential with performance-based items to prove pros can think on their feet to perform critical IT support tasks in the moment. It is trusted by employers around the world to identify the go-to person in end point management and technical support roles. CompTIA A+ is regularly re-invented by IT experts to ensure that it validates core skills and abilities demanded in the workplace. This course follows after the A+ Part 1 course and prepares you for the A+ Core 2 exam 220-1101. Prerequisites While there are no prerequisites for this course, please ensure you have the right level of experience to be successful in this training. LESSON 1: CONFIGURING WINDOWS * Topic 1A: Configure Windows User Settings * Topic 1B: Configure Windows System Settings LESSON 2: MANAGING WINDOWS * Topic 2A: Use Management Consoles * Topic 2B: Use Performance and Troubleshooting Tools * Topic 2C: Use Command-line Tools LESSON 3: IDENTIFYING OS TYPES AND FEATURES * Topic 3A: Explain OS Types * Topic 3B: Compare Windows Editions LESSON 4: SUPPORTING WINDOWS * Topic 4A: Perform OS Installations and Upgrades * Topic 4B: Install and Configure Application * Topic 4C: Troubleshoot Windows OS Problems LESSON 5: MANAGING WINDOWS NETWORKING * Topic 5A: Manage Windows Networking * Topic 5B: Troubleshoot Windows Networking * Topic 5C: Configure Windows Security Settings * Topic 5D: Manage Windows Shares LESSON 6: MANAGING LINUX AND MACOS * Topic 6A: Identify Features of Linux * Topic 6B: Identify Features of macOS LESSON 7: CONFIGURING SOHO NETWORK SECURITY * Topic 7A: Explain Attacks, Threats, and Vulnerabilities * Topic 7B: Compare Wireless Security Protocols * Topic 7C: Configure SOHO Router Security * Topic 7D: Summarize Security Measures LESSON 8: MANAGING SECURITY SETTINGS * Topic 8A: Configure Workstation Security * Topic 8B: Configure Browser Security * Topic 8C: Troubleshoot Workstation Security Issues LESSON 9: SUPPORTING MOBILE SOFTWARE * Topic 9A: Configure Mobile OS Security * Topic 9B: Troubleshoot Mobile OS and App Software * Topic 9C: Troubleshoot Mobile OS and App Security LESSON 10: USING SUPPORT AND SCRIPTING TOOLS * Topic 10A: Use Remote Access Technologies * Topic 10B: Implement Backup and Recovery * Topic 10C: Explain Data Handling Best Practices * Topic 10D: Identify Basics of Scripting LESSON 11: IMPLEMENTING OPERATIONAL PROCEDURES * Topic 11A: Implement Best Practice Documentation * Topic 11B: Use Proper Communication Techniques * Topic 11C: Use Common Safety and Environmental Procedures

4 Days -------------------------------------------------------------------------------- We run weekly open courses for accreditations including CPCS, CSCS Health & Safety, NPORS, IFAP, SMSTS and more. We also offer bespoke training courses or in house training nationwide. -------------------------------------------------------------------------------- Upon arrival at our centres candidates will be inducted to the site by their qualified instructor who will be training them for the day. After registration candidates will be issued with a pack full of information relevant to the category they are being trained in. Included in this pack are theory questions, practical specifications, pre-start check lists, marking sheets and more. We ensure that these materials provided excel the individual to successfully complete their course. We are aware that having good quality machines give candidates a significant advantage when undertaking their training. We endeavour to supply candidates with the highest quality plant training and machinery on our site using a variety of certified suppliers. These machines come equipped with all the health and safety features and include – but are not limited to – JCB, Magni, Merlo, Caterpillar, Thwaits and Manitou. -------------------------------------------------------------------------------- Get in touch with us today to find the right course for you. Our team are on-hand and ready to support you with your construction training requirements.

A two hour machine sewing workshop to create your own bunting. Covering machine sewing basics and hints and tips for a professional finish.

A short workshop to get to know your sewing machine and gain confidence in stitching seams and topstitching. Problem solving and threading up also covered.

3 Days -------------------------------------------------------------------------------- We run weekly open courses for accreditations including CPCS, CSCS Health & Safety, NPORS, IFAP, SMSTS and more. We also offer bespoke training courses or in house training nationwide. -------------------------------------------------------------------------------- Upon arrival at our centres candidates will be inducted to the site by their qualified instructor who will be training them for the day. After registration candidates will be issued with a pack full of information relevant to the category they are being trained in. Included in this pack are theory questions, practical specifications, pre-start check lists, marking sheets and more. We ensure that these materials provided excel the individual to successfully complete their course. We are aware that having good quality machines give candidates a significant advantage when undertaking their training. We endeavour to supply candidates with the highest quality plant training and machinery on our site using a variety of certified suppliers. These machines come equipped with all the health and safety features and include – but are not limited to – JCB, Magni, Merlo, Caterpillar, Thwaits and Manitou. -------------------------------------------------------------------------------- Get in touch with us today to find the right course for you. Our team are on-hand and ready to support you with your construction training requirements.

Let's start an exciting voyage through our online Italian course, covering levels A1, A2, and A2+. Attain fluency in Italian and earn a certification! Enrol today!

Developing a solid foundation in Greek grammar will help you create your own sentences correctly and will also make it easier to improve your communication skills in both spoken and written Greek. So this course has been designed to help you steadily advance with the Greek language. Here, on the Greek Online School Learning Management System (LMS) you will find all the grammar phenomena that you need to know for the A2 Level (basic knowledge) in Greek, the language that influenced all European languages.

Creative and Courageous Conversation about Spiritual Direction in the 21st Century.  In this conversation, we will be pondering  What language can we use to confidently communicate what we offer in fresh and relevant ways? Naomi Gates will be leading this discussion.