Overview Internet is the main source of marketing today and Digital Marketing along with Social Media Marketing helps the business to stay alive in the digital world. Earlier companies use to spend a lot of money on traditional ways of marketing and still, they were not able to reach global clients. With the existence of Digital marketing, they are able to break the barriers to reaching global clients. With the use of Social Media Marketing and Digital Marketing organisations are able to reach every corner of the world and also it is very cost-effective. Digital Marketing encompasses various channels like Search Engine Optimisation, Social Media Marketing like usage of Facebook, Facebook marketing, Ad Words, and Email Campaigns and is list is longer. All these tools are used to cover global marketing. No matter where you are located in the world, your product can reach clients anywhere in the world. This course will help develop innovative social media strategies, and to boost brand awareness with rich content. With the effective analysis of campaign results, you'll be on track to exceed sales targets and advance your career with the latest social media marketing techniques.
About this training course The smart meter or smart grid represents the next-generation electrical power system. This system uses information, data & communication technology within generation, delivery and consumption of electric energy. This 4-day course will equip you with the innovations that are shaping the power generation and distribution systems and will cover topics ranging from Smart Metering Architecture, Cybersecurity, Smart Grid Systems and Power Line Communications. Training Objectives By participating in this course, you will be able to: Comprehend the Smart Grid and Smart Meters architecture Review latest trends and challenges within the Smart Grid Technology Perform analysis on smart electronic meters Comply with regulatory and metering standards Recognize the importance of cybersecurity in smart grids Maximize efficiency, reliability, and longevity of your smart meters and equipment Gain valuable insights into power quality and harmonics Target Audience This course will greatly benefit the following groups but not limited to: Smart Grid managers and engineers Smart Meters managers and engineers Power plant managers Outage managers Maintenance and operations engineers Power regulatory personnel Transmission managers and engineers Distribution managers and engineers IT managers Renewable energy managers and engineers Course Level Basic or Foundation Intermediate Training Methods The training instructor relies on a highly interactive training method to enhance the learning process. This method ensures that all participants gain a complete understanding of all the topics covered. The training environment is highly stimulating, challenging, and effective because the participants will learn by case studies which will allow them to apply the material taught in their own organization. Course Duration: 4 days in total (28 hours). Training Schedule 0830 - Registration 0900 - Start of training 1030 - Morning Break 1045 - Training recommences 1230 - Lunch Break 1330 - Training recommences 1515 - Evening break 1530 - Training recommences 1700 - End of Training The maximum number of participants allowed for this training course is 25. This course is also available through our Virtual Instructor Led Training (VILT) format. Trainer Your expert course leader is a professional engineer with extensive experience in power system studies, substation design field-testing, and EHS programs settings for Mining and Electrical Utilities sectors. He was formally the Engineering Manager at GE Canada in Ontario. He received his M.Sc. in electrical engineering from the University of New Brunswick and his MBA from Laurier School of Business in Waterloo. He has managed and executed more than 150 engineering projects on substation design EMF audits and power system studies and analyses, EMF audits and grounding audits, for major electrical utilities, mines, oil and gas, data centers, industrial and commercial facilities in Canada and the U.S. He is a certified professional engineer in the provinces of Ontario and Alberta. He has various IEEE publications, has served as a technical reviewer for many IEEE journals in power systems and control systems, and is the chair of the Industry Application Chapter (IAS) for IEEE Toronto Section. He remains a very active member for the IEEE substation committee of IEEE Std. 81 ground testing (WGE6) and IEEE Std. 80 ground design (WGD7). A certified electrical safety trainer by GE Corporate and a Canadian Standard Association (CSA) committee member at the mining advisory panel for electrical safety, he also taught many technical courses all over Canada to industrial customers, electrical consultants as well as to electrical utilities customers. Highlighted Projects: Various Power System Studies for 345/230 kV Stations - Nova Scotia Power (EMERA) RF audits for Telecom tower and antennas - Cogeco/Rogers Mobile Power System analysis - Powell Canada Structural/Geotechnical Design and upgrades - Oakville Hydro Underground Cables testing and sizing - Plan Group Relay programming and design optimization - Cenovus Canada Different Arc Flash Analysis and BESS Design - SNC Lavalin Environmental site assessment (ESA) Phase I/II for multiple stations - Ontario Electromagnetic compatibility (EMC) assessment for Toronto LRT expansion - MOSAIC Battery energy storage system (BESS) installation at City of London - Siemens Canada EMF audits for 500 kV Transmission Lines - Hydro One EMF audits for 500 kV Transmission Lines - Hydro Quebec AC interference for 138 kV line modeling and mitigations - HBMS Mine 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
About this training course Artificial lift systems are an important part of production operations for the entire lifecycle of an asset. Often, oil and gas wells require artificial lift for most of the life cycle. This 5-day training course offers a thorough treatment of artificial lift techniques including design and operation for production optimization. With the increasing need to optimize dynamic production in highly constrained cost environments, opportunities and issues related to real-time measurements and optimization techniques needs to be discussed and understood. Artificial lift selection and life cycle analysis are covered. These concepts are discussed and reinforced using case studies, quizzing tools, and exercises with software. Participants solve examples and class problems throughout the course. Animations and videos reinforce the concepts under discussion. Understanding of these important production concepts is a must have to exploit the existing assets profitably. Unique Features: Hands-on usage of SNAP Software to solve gas-lift exercises Discussion on digital oil field Machine learning applications in gas-lift optimization Training Objectives After the completion of this training course, participants will be able to: Understand the basics and advanced concepts of each form of artificial lift systems including application envelope, relative strengths, and weaknesses Easily recognize the different components from downhole to the surface and their basic structural and operational features Design and analyze different components using appropriate software tools Understand challenges facing artificial lift applications and the mitigation of these challenges during selection, design, and operation Learn about the role of digital oilfield tools and techniques and their applications in artificial lift and production optimization Learn about use cases of Machine learning and artificial intelligence in the artificial lift Target Audience This training course is suitable and will greatly benefit the following specific groups: Production, reservoir, completion, drilling and facilities engineers, analysts, and operators Anyone interested in learning about selection, design, analysis and optimum operation of artificial lift and related production systems will benefit from this course. Course Level Intermediate Advanced Training Methods The training instructor relies on a highly interactive training method to enhance the learning process. This method ensures that all participants gain a complete understanding of all the topics covered. The training environment is highly stimulating, challenging, and effective because the participants will learn by case studies which will allow them to apply the material taught in their own organization. Course Duration: 5 days in total (35 hours). Training Schedule 0830 - Registration 0900 - Start of training 1030 - Morning Break 1045 - Training recommences 1230 - Lunch Break 1330 - Training recommences 1515 - Evening break 1530 - Training recommences 1700 - End of Training The maximum number of participants allowed for this training course is 20. This course is also available through our Virtual Instructor Led Training (VILT) format. Prerequisites: Understanding of petroleum production concepts. Each participant needs a laptop/PC for solving class examples using software to be provided during class. Laptop/PC needs to have a current Windows operating system and at least 500 MB free disk space. Participants should have administrator rights to install software. Trainer Your expert course leader has over 35 years' work-experience in multiphase flow, artificial lift, real-time production optimization and software development/management. His current work is focused on a variety of use cases like failure prediction, virtual flow rate determination, wellhead integrity surveillance, corrosion, equipment maintenance, DTS/DAS interpretation. He has worked for national oil companies, majors, independents, and service providers globally. He has multiple patents and has delivered a multitude of industry presentations. Twice selected as an SPE distinguished lecturer, he also volunteers on SPE committees. He holds a Bachelor's and Master's in chemical engineering from the Gujarat University and IIT-Kanpur, India; and a Ph.D. in Petroleum Engineering from the University of Tulsa, USA. Highlighted Work Experience: At Weatherford, consulted with clients as well as directed teams on digital oilfield solutions including LOWIS - a solution that was underneath the production operations of Chevron and Occidental Petroleum across the globe. Worked with and consulted on equipment's like field controllers, VSDs, downhole permanent gauges, multiphase flow meters, fibre optics-based measurements. Shepherded an enterprise-class solution that is being deployed at a major oil and gas producer for production management including artificial lift optimization using real time data and deep-learning data analytics. Developed a workshop on digital oilfield approaches for production engineers. Patents: Principal inventor: 'Smarter Slug Flow Conditioning and Control' Co-inventor: 'Technique for Production Enhancement with Downhole Monitoring of Artificially Lifted Wells' Co-inventor: 'Wellbore real-time monitoring and analysis of fracture contribution' Worldwide Experience in Training / Seminar / Workshop Deliveries: Besides delivering several SPE webinars, ALRDC and SPE trainings globally, he has taught artificial lift at Texas Tech, Missouri S&T, Louisiana State, U of Southern California, and U of Houston. He has conducted seminars, bespoke trainings / workshops globally for practicing professionals: Companies: Basra Oil Company, ConocoPhillips, Chevron, EcoPetrol, Equinor, KOC, ONGC, LukOil, PDO, PDVSA, PEMEX, Petronas, Repsol, , Saudi Aramco, Shell, Sonatrech, QP, Tatneft, YPF, and others. Countries: USA, Algeria, Argentina, Bahrain, Brazil, Canada, China, Croatia, Congo, Ghana, India, Indonesia, Iraq, Kazakhstan, Kenya, Kuwait, Libya, Malaysia, Oman, Mexico, Norway, Qatar, Romania, Russia, Serbia, Saudi Arabia, S Korea, Tanzania, Thailand, Tunisia, Turkmenistan, UAE, Ukraine, Uzbekistan, Venezuela. Virtual training provided for PetroEdge, ALRDC, School of Mines, Repsol, UEP-Pakistan, and others since pandemic. 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
Looking for career-focused practical filmmaking? Do you want to learn more about the work of different departments in film and get hands-on filmmaking experience before deciding on your career path? Screen and Film School Brighton’s Professional Diploma is a 9-month part-time course designed to provide you with the essential skills required to successfully operate in the UK film and TV industry today. The course allows you to specialise in one field or become a self-sufficient freelancer such as a shooting producer director, editor, production coordinator or content creator.
Schema Therapy Package: Break Free from Old Patterns, Cultivate Emotional Well-being Discover the transformative potential of Schema Therapy with Miss Date Doctor’s specialized package. Schema therapy integrates cognitive-behavioural techniques with elements of psychodynamic therapy, aiming to identify and modify long-standing patterns or schemas that contribute to emotional and interpersonal difficulties. Under the guidance of our skilled therapists, you’ll explore deep-rooted patterns and learn to challenge and change unhelpful behaviors and beliefs. As you break free from old patterns, you’ll cultivate emotional well-being and create healthier relationships. Uncover your true self and experience profound personal growth with the Schema Therapy package. 3 X1 hour session https://relationshipsmdd.com/product/schema-therapy-package/
About this training course This 5-days comprehensive training course provides not only an introduction into the issues associated with the development of the pipeline transportation of CO2 from its Capture, it's transportation, storage and usage but also provides an in depth understanding of the issues to be considered in the development, design and operations of these pipelines. The theme throughout this training course is CO2 Flow Assurance and Innovative Technologies. Each training day will consist of lectures in the morning and a hands-on workshop in the afternoon. The workshop allows the participants to appreciate the design process associated with CO2 transport and its operations. Various software will be available during the workshop to predict thermo hydraulics and associated phase flows through CO2 pipelines and the attached infrastructure. Further software to assess surge and environmental safety will also be available. The CO2 pipeline design approach will consider an integrated solution through modelling the CO2 capture system as well as the host storage facility. The participants will have a total appreciation of the methodology required to develop a CO2 transportation system and have an understanding of all of the Flow Assurance, risks, and operating issues and technology requirements. Training Objectives After the completion of this training course, participants will be able to: Understand the process required and identify data to analyse Flow Assurance for CO2 pipeline transport Review and Identify the Flow Assurance issues required to be evaluated for CO2 pipeline transport design and operations methodology. These include; Hydrates, Slugging, Corrosion, Scaling, Fluid Phase Behaviour and transient conditions Establish the studies to be undertaken for each area of CO2 transport including 'Rules of Thumb' and software to be used Comprehend the need for innovative methods and the technologies to mitigate Flow Assurance issues and the need for economics considerations Appreciate the need for an integrated analysis of the CO2 transport system from the CO2 capture to the host storage facility Gain an appreciation of the emerging and enabling technologies for CO2 transport and storage application Dive deeper into the operational strategies requirements to mitigate Flow Assurance issues Target Audience This training course is suitable and will greatly benefit the following specific groups: Reservoir Engineers Flow Assurance Engineers Thermodynamics Engineers Process and Chemical Engineers Pipeline Engineers Facilities Engineers Control and Subsea Engineers working in the Oil and Gas industries Engineers in other disciplines may attend that require an appreciation of CO2 pipeline transport Control and Subsea Engineers working in the Oil and Gas industries Engineers in other disciplines may attend that require an appreciation of CO2 pipeline transport Course Level Intermediate Training Methods The training instructor relies on a highly interactive training method to enhance the learning process. This method ensures that all participants gain a complete understanding of all the topics covered. The training environment is highly stimulating, challenging, and effective because the participants will learn by case studies which will allow them to apply the material taught in their own organization. Course Duration: 5 days in total (35 hours). Training Schedule 0830 - Registration 0900 - Start of training 1030 - Morning Break 1045 - Training recommences 1230 - Lunch Break 1330 - Training recommences 1515 - Evening break 1530 - Training recommences 1700 - End of Training Course delivery: The maximum number of participants allowed for this training course is 20. A basic understanding of thermo-hydraulics would be advantageous. Morning Lectures and afternoon hands-on practical workshop. Special features: PC-based simulation software demonstration Workshop for hands-on training Course References & Additional resources: 'CO2 Transport from Capture to Storage and Usage', 1st Edition Handouts Pre & Post Assessment Trainer Your expert course leader is a renowned specialist in flow assurance management for the oil & gas field developments. His expertise enables him to support the operating and contracting companies as well as financial institutions regarding due diligence on offshore development investment decisions and associated operational system risks. Technical assessment of fields for acquisition and production enhancement opportunity. He possesses specialist expertise in evaluating difficult pipeline fluids transport such as Ethylene, Carbon Dioxide and Hydrogen through feasibility studies and technical reviews for clients. He has an exceptional academic background and natural leadership abilities are supported by practical experience of diverse projects worldwide, along with numerous publications at key conferences and publication of four books. Particular interests in developing novel and innovative technologies for subsea applications to solve difficult flow assurance problem areas and improve field development economics. He has worked on major industry projects including; Concorde aircraft fuelling system, the Channel Tunnel aerodynamics and the first deep water oil field development (Foinaven) in the West of Shetland. He is also currently developing a renewable energy solar farm and carbon neutral energy crop (Miscanthus) for domestic and commercial power generation application. He has developed in-house resources including specialist oil & gas field development evaluation software for subsea and onshore field infrastructure development options including; costing and financial analysis, reservoir viability, flow assurance assessment, subsea processing and boosting technologies, flow induced vibrations, surge analysis, heat transfer and chemical injection systems. Patents: · Subsea Seabed Power Generation for Depleting Gas fields Using Renewable Energy · Gas to Liquids Absorption Technology (GTLA) for subsea and onshore Flow Assurance applications · Subsea Gas Compressor System using pigs and liquid pumps · Pressure Boosting using water injection pumps · B&W Mentor subsea multi-phase meter · Surge suppression using a contained gas method for pipeline systems 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
About this training course This 5-days comprehensive training not only an introduction into the issue associated with the development of oil and gas fields but also provides an in depth understanding of the issues to be considered in the development of these fields. The theme throughout this training course is Flow Assurance and Innovative Technologies. Each day consists of lectures in the morning and a hands-on workshop in the afternoon. The workshop allows the participants to appreciate the design process associated with field developments. Various software will be available during the workshop to predict Multiphase flows through wells, pipelines and risers, as well as evaluating reservoir production profiles using alternative technologies to develop reservoirs. Further software to assess Surge and environmental safety will also be available. The field design approach will consider an integrated solution through modelling the reservoir decline, wells, flowlines, risers and the host facility. The participants will have a total appreciation of the methodology required to develop offshore oil and gas fields and have an understanding of all of the Flow Assurance issues and technology requirements. Training Objectives After the completion of this training course, participants will be able to: Understand the process required and identify data to analyse Flow Assurance for oil and gas fields. Examine and Identify the Flow Assurance issues required to be evaluated for oil and gas fields design. These include; Wax, Hydrates, Slugging, Corrosion, Sand Erosion, Scaling and Surge. Establish the studies to be undertaken for each area of Flow Assurance including 'Rules of Thumb' and software to be used. Prioritize the need for innovative methods and the technologies to solve Flow Assurance issues and the need for economics considerations. Appreciate the need for an integrated analysis of the oil and fields from the reservoir to the host processing facility. Gain an appreciation of the emerging and enabling technologies for offshore fields application. Dive deeper into the operational strategies requirements to mitigate Flow Assurance issues. Target Audience This training course is suitable and will greatly benefit the following specific groups: Reservoir Engineers Flow Assurance Engineers Thermodynamics Engineers Process and Chemical Engineers Pipeline Engineers Facilities Engineers Control and Subsea Engineers working in the Oil and Gas industries Engineers in other disciplines may attend that require an appreciation of Flow Assurance Course Level Intermediate Training Methods The training instructor relies on a highly interactive training method to enhance the learning process. This method ensures that all participants gain a complete understanding of all the topics covered. The training environment is highly stimulating, challenging, and effective because the participants will learn by case studies which will allow them to apply the material taught in their own organization. Course Duration: 5 days in total (35 hours). Training Schedule 0830 - Registration 0900 - Start of training 1030 - Morning Break 1045 - Training recommences 1230 - Lunch Break 1330 - Training recommences 1515 - Evening break 1530 - Training recommences 1700 - End of Training Course delivery: This course is limited to a maximum of 20 participants only. A basic understanding of thermo-hydraulics would be advantageous. Morning Lectures and afternoon hands-on practical workshop. Special features: PC-based simulation software demonstration Workshop for hands-on training Course References & Additional resources: 'Flow Assurance for Oil and Gas Fields Production Transport', 1st Edition Handouts Pre & Post Assessment Trainer Your expert course leader is a renowned specialist in flow assurance management for the oil & gas field developments. His expertise enables him to support the operating and contracting companies as well as financial institutions regarding due diligence on offshore development investment decisions and associated operational system risks. Technical assessment of fields for acquisition and production enhancement opportunity. He possesses specialist expertise in evaluating difficult pipeline fluids transport such as Ethylene, Carbon Dioxide and Hydrogen through feasibility studies and technical reviews for clients. He has an exceptional academic background and natural leadership abilities are supported by practical experience of diverse projects worldwide, along with numerous publications at key conferences and publication of four books. Particular interests in developing novel and innovative technologies for subsea applications to solve difficult flow assurance problem areas and improve field development economics. He has worked on major industry projects including; Concorde aircraft fuelling system, the Channel Tunnel aerodynamics and the first deep water oil field development (Foinaven) in the West of Shetland. He is also currently developing a renewable energy solar farm and carbon neutral energy crop (Miscanthus) for domestic and commercial power generation application. He has developed in-house resources including specialist oil & gas field development evaluation software for subsea and onshore field infrastructure development options including; costing and financial analysis, reservoir viability, flow assurance assessment, subsea processing and boosting technologies, flow induced vibrations, surge analysis, heat transfer and chemical injection systems.
An evening of Shamanic healing, plant medicine and live music to heal and grow. We invite you to attend an evening of shamanic healing, plant medicine and live music to heal and grow. We are excited to share three powerful medicines from the Amazon with you - Rapé, Sananga and Cacao. There will be adequate time for you to sit with the effects of each medicine while we sing and play to guide you on your journey. You are welcome to simply listen and enjoy the ceremony or if you would like to join in and sing, play or dance, you are welcome to! The Plant Medicines Cacao is known as the "food of the gods.” It has been used for centuries in ceremonial settings to open the heart, connect with our inner essence, and clear stagnant emotional energy from the body. Sip on a warm cup of ceremonial Cacao, prepared with intention and love, as it takes you on a journey and guides you back to your heart. Rapé is a powerful shamanic medicine renowned for its purifying and grounding properties. It is snuff made from tobacco and other medicinal or sacred trees which is applied by being blown into each nostril. Our team will offer individual servings of high-quality Rapé, made by indigenous tribes. You will have the opportunity to choose the strength of your dose, allowing you to navigate this sacred medicine at your own pace. The application of Rapé immediately focuses the mind, stops its chattering, and creates space. It helps release emotional, physical, and spiritual illness and eases negativity and confusion, facilitating clarity, alignment, and a profound connection with yourself. Sananga is a traditional Brazilian medicine used for both spiritual and physical healing. Sananga possesses the ability to clear blocked energies, offering emotional, spiritual, and physical release. The plant-based eye drops are said to enhance eyesight and have long been used by indigenous tribes to prevent and treat ocular diseases like glaucoma, cataracts, near-sightedness, and blindness. Sananga is also commonly used to treat skin diseases, infections, arthritis, cancer, and to clear a person of what is called panema - anxiety, depression, bad luck, negative energies and laziness. This powerful plant guides us towards the roots of our challenges and provides guidance on our healing journey. Preparation You are advised to fast (just water) for at least one hour before the ceremony and avoid any heavily processed or fried foods during the day. Please wear comfortable clothing. If you would like to bring a guitar, drum, shaker or other instrument to play, please do. Price The ticket price for this event is on a sliding scale. Please pay what you can afford. Your Facilitator: Melissa is a renowned Sound Healer, Life Coach, Tantric Practitioner, and Psychedelic Retreat Facilitator. With a passion for empowering individuals, Melissa offers transformative one-on-one coaching sessions and leads workshops and retreats in the areas of Self Healing, Sexual Mastery, and Psychedelics. Melissa's background as a Lawyer brings a unique perspective to her approach. She is grounded and non-dogmatic and empowers her clients to balance their beliefs with a healthy amount of critical thinking and discernment. In her work as a retreat leader, Melissa creates safe and supportive environments for individuals to explore the transformational power of Ayahuasca. With her deep love and respect for shamanic traditions, Melissa guides participants through profound inner experiences, facilitating healing, self-discovery, and personal growth. Her commitment to personal and collective transformation have earned her recognition as a leading figure in her respective fields. Her comprehensive approach, combining ancient wisdom with modern techniques, empowers individuals to transcend their limitations, unlock their potential, and live lives of purpose and fulfilment. Find us on social media: @numinity.collective Join our Whatsapp Group for new event updates.
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