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We deliver Workplace PAT Testing Courses across most of the UK to assist businesses with Compliance. We also work with Bridges into Work and ReACT in association with Careers Wales and the Welsh Government to offer work based skills which some Candidates could be eligible for Government funding.

Overview This training course is structured around the ISO 31000:2009 framework, principles and processes. It will also demonstrate how to develop internal control mechanisms and explain how to measure risk in terms of probability and potential impact, at the same time as ensuring that the organisation complies with increasingly strict international standards of corporate governance.

Enhance your knowledge in coal power plant life cycle management and flexible operations with EnergyEdge. Learn about decommissioning, preservation, repurposing, and recommissioning.

Transport Compliance, Audits, Health and Safety, HGV compliance, PSV compliance, Compliance, Templates, Toolbox Talk, Professional Development, Assistance, Operator Licence assistance,

Elevate your expertise in LNG terminal operations safety through our classroom training course. Energyedge provides industry-leading expertise and guidance.

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

About this Training Course Reservoir engineering methods, data and models are used in the E&P business to describe and optimise hydrocarbon recovery. This 5 full-day course addresses reservoir engineering concepts and methods to enable cross-disciplinary team work and the smooth exchange of ideas and experience. In this course, participants will gain an in-depth understanding of the fundamentals of reservoir engineering and a broad range of modern reservoir engineering principles and practices for reservoir development and production, including the estimation of oil and gas reserves. The topics covered in this course will be illustrated with practical and actual field cases. Some self-study or reading will be required from participants. Training Objectives By the end of this course, participants will be able to: Describe use of permeability and fluid saturation in reservoir engineering. Explain the assessment of hydrocarbon resources and recoverable reserves estimation. Understand analysis and modelling of fluid behaviour. Explain oil and gas reservoir performance. Describe material balance methods in oil and gas reservoirs. Understand design and analysis of well tests. Understand analysis and production of producing wells and forecasting methods. Describe fluid displacement at the pore and reservoir scale. Explain reservoir simulation approaches. Describe tools for handling the uncertainty in reservoir analysis. Describe various recovery methods from primary to enhanced recovery. Target Audience This course is intended for professionals with prior technical or engineering exposure to exploration and production activities. Targeted participants include geoscientists, production engineers, petrophysicists and petroleum engineers involved with exploration and development of oil & gas reservoirs. The course will also benefit petroleum engineering team leaders as well as IT staff and support staff who work with reservoir engineering, development and production departments. Course Level Basic or Foundation Trainer Your expert course leader is an independent Reservoir Engineering Consultant, providing project consultancy and reservoir engineering training for global customers. He retired from Shell in 2012 and during the last years of his Shell career, he held the Senior Reserves Consultant for the Middle East and Reservoir Engineering Discipline Lead positions. He is a seasoned Petroleum Engineering professional, with global experience in Shell companies and joint ventures (NAM, SSB, SCL, PDO, SKDBV). His technical expertise is in reserves and resource management, reservoir engineering quality assurance, and staff development as well as carbonate reservoirs, modelling and reservoir simulation.  PROFESSIONAL EXPERIENCE 2012 to date Independent Reservoir Engineering Consultant Petroleum and reservoir engineering advice, training and services. Reservoir engineering training for major oil companies, engineering firms and other global customers. Assurance of SPE and SEC reserves compliance. Participation in SPE reserves and resources estimation Advanced Technology Workshops both as an organising committee member and as session speaker.   2008 - 2012 Shell International E&P, the Hague, the Netherlands Senior Reserves Consultant for Shell business units and joint ventures in the Middle East Region Assurance of SEC and SPE compliance of reserves and resources. Industry publications and conference contributions a.o. SPE guidelines on probabilistic reserves estimation.   2006 - 2008 Shell E&P Technology Solutions, Rijswijk, the Netherlands Reservoir Engineering Discipline Lead Responsible for Reservoir Engineering in global projects and for staff planning and development (over 60 international Reservoir Engineers).   2001 - 2005 Centre for Carbonate Studies, SQU, Oman / Shell International E&P Applications and Research / Shell Representative Office Oman   Petroleum Engineering Manager PE Manager in the Carbonate Research Centre, a joint venture between Sultan Qaboos University in Oman and Shell International. Industrial research projects and teaching on recovery aspects of carbonate reservoir development.   1997 - 2000 Shell International E&P, Rijswijk, the Netherlands Principal Reservoir Engineer Coordination of the NOV subsurface team in Shell Kazakhstan Development BV in 2000. Leading role in Shell Gamechanger project on natural gas hydrates. Acting Shell Group Reserves Co-ordinator in 1997-1998. Facilitation of workshops with government shareholders, including discussions on sensitive reserves issues (BSP Petroleum Unit Brunei, PDO Oman, SPDC government Nigeria).   1992 - 1996 Shell Training Centre, Noordwijkerhout, the Netherlands Reservoir Engineering Programme Training Director Advanced PE training events, QA/QC, design and delivery of courses to Shell staff.   1985 - 1992 Shell International, SIPM, the Hague, The Netherlands Senior Reservoir Engineer Reservoir simulation, integrated reservoir modelling and gas field development and major contributor to the Shell internal Gas Field Planning Tool development. Full field reservoir simulation projects supporting Field Development Plans, operational strategies and unitisation negotiations for Shell Group Operating Companies in the United Kingdom, New Zealand and Egypt.   1984 - 1985 Geological Survey of the Netherlands, Ministry of Economic Affairs Reservoir Engineering Section Head Responsible for Petroleum Engineering advice on oil and gas licences to the Ministry of Economic Affairs. First-hand experience with a government view on resource management.   1976 - 1984 NAM, Assen, The Netherlands and SSB/SSPC, Miri, Malaysia Wellsite Operations Engineer / Operational Reservoir Engineer POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information post training support and fees applicable Accreditions And Affliations