5 Quantitative Methods 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

Understand the needs and benefits arising from a structured project risk management approach, the process and supporting methods for identifying analysing and responding to risks. Course overview Duration: 2 day (13 hours) Our Project Risk Management course addresses risk management throughout the project lifecycle. This course is designed for project staff, including project leaders, sponsors, project team members, support staff and functional staff involved in project activity. The workshop is especially suited to teams working on bids, feasibility and project start up. The workshop covers the need and benefits arising from a structured project risk management approach, the process and supporting methods for identifying analysing and responding to risks, human behavioural factors affecting risk management performance, and organisational interfaces and governance requirements. Objectives  By the end of the course you will be able to: Describe success factors and benefits arising from effective risk management Explain human behaviour factors affecting risk management Establish the project context and conduct an initial risk assessment Define an appropriate strategy and produce a risk management plan Define risk identification strategies and apply appropriate identification methods Identify and record important risk information including ownership Establish risk probability and impact levels; produce probability impact charts and severity time charts Establish exposure levels and contingency requirements Explain the principles of quantitative analysis Define and evaluate response options Implement effective risk management process control Content Principles of risk management Terminology Purpose Success factors Benefits and overall process Human factors that impact on risk management Initiate Analyse and determine context factors relevant to risk management Develop a robust risk management strategy for the life of the project How to conduct an initial risk assessment and define an outline strategy Identification Development of a risk identification strategy Appropriate methods and their strengths and weaknesse Determine an appropriate strategy and identify risks in a given case study Animating text Slide titles Bullet points Applying animation to Slide Master Assessment Methods commonly used for assessing and prioritising risks Evaluating exposure and contingency requirement Demonstration of quantitative methods and exercises to assess risks and contingency levels Planning and implementing responses Appropriate methods for responding to risks Defining implementation and control plans Assigning ownership Defining appropriate plans Conducting net benefits analysis and examining effectiveness Manage process Organisational interfaces and specific requirements to ensure appropriate controls Improvements and compliance with governance requirements

About this Virtual Instructor Led Training (VILT) This 4 half-day Virtual Instructor Led Training (VILT) course presents the principles and best practices of portfolio management in the upstream (E&P) oil and gas industry. The VILT course is equally valuable for small independents, large integrated international companies and national oil companies. The VILT course consists of presentations, case studies, illustrative practical exercises and syndicate discussions. Particular emphasis is given to pragmatic portfolio management approaches and solutions which can be implemented swiftly without recourse to major investments in planning and portfolio management software. The VILT course will draw on examples from your expert course leader's 35+ years' experience in the oil and gas industry as an explorationist, upstream vice-president and management consultant. The VILT course handout will comprise softcopy slides used in the presentation and a softcopy workbook for the exercises. Participants will gain proficiency in portfolio management techniques, understand how and why to undertake this activity and be able to apply key concepts directly in the business of their teams / divisions. The VILT course will be presented over 4 half-days, using Microsoft Teams or Zoom and a proprietary set of VILT tools. Participants will be asked to complete a pre course questionnaire (PCQ) addressing their objectives and experience, and attend a session to familiarise themselves with VILT tools before course commencement.     Training Objectives To present the tools, concepts and principles of portfolio management To define the quantitative metrics which are used to describe projects in a portfolio To understand the benefits of portfolio management at different stages of the upstream business: in strategy development, opportunity screening, business development, drilling prospects, conducting appraisal of discoveries and developing fields To put portfolio management in the organisational context by describing the role of the portfolio management team and examining how value assurance (quality control) is best conducted on portfolio data for projects and assets To demonstrate how portfolio management contributes to improved business performance By the end of the VILT course, participants will understand: Key concepts and principles of portfolio management How to design a simple portfolio database and describe complex projects in a small number of objective metrics How to segment the portfolio into meaningful units How to use portfolio data in making business choices and decisions at the strategic and tactical levels The extent to which it is meaningful and reasonable to make comparisons across different portfolio segments How the portfolio management team can support the wider business in decision-making Target Audience This VILT course is specially designed for exploration and development geoscientists, E&P economists and finance staff, and E&P managers. Both technical and non-technical staff will benefit from the concepts presented. Companies are encouraged to send participants from different functions and seniority levels to gain great benefits especially those which would like to implement the concepts presented in this VILT course. Course Level Basic or Foundation Training Methods The VILT course will be delivered online in 4 half-day sessions comprising 4 hours per day, with 2 breaks of 10 minutes per day. The VILT course will be presented in an interactive workshop format that allows for discussion. Course Duration: 4 half-day sessions, 4 hours per session (16 hours in total). Trainer Your expert course leader draws on more than 35 years of experience managing, reviewing and directing projects in all aspects of the exploration business: from exploration business development (new ventures), through prospect maturation and drilling, to the appraisal of discoveries. He has more than 30 years' experience with Shell International, followed by 10 years consulting to NOCs in Asia Pacific, Africa and South America and independent oil companies in the United Kingdom, continental Europe and North America. Other than delivering industry training, he has worked on projects for oil & gas companies of all sizes, including independents, national oil companies and (super)-majors, private equity firms, hedge funds and investment banks, and leading management consulting firms. He is an alumnus of Cambridge University. He has M.A and Ph.D. degrees in geology and is a Fellow of the Geological Society of London as well as a respected speaker on management panels at international conferences. Professional Experience Management consultancy & executive education: Advice to investment banks, businesses and major consulting firms. Specialist expertise in upstream oil & gas, with in depth experience in exploration strategy, portfolio valuation and risk assessment. Leadership: Managed and led teams and departments ranging from 3 - 60 in size. Provided technical leadership to a cadre of 800 explorationists in Shell worldwide. Member of the 12-person VP team leading global exploration in Shell, a $3 bln p.a. business and recognised as the most effective and successful among its industry peers. Accountability & decision-making: Accountable for bottom-line results: in a range of successful exploration ventures with budgets ranging from $10's million to $100's million. Made, or contributed to, complex business decisions / investments, taking into account strategic, technical, commercial, organisational and political considerations. Corporate governance: Served as non-executive director on the Boards of the South Rub al Khali Company (oversight of gas exploration studies and drilling in Saudi Arabia) and SEAPOS B.V. (exploration deep-water drilling and facilities management). Technical & operations: Skilled in exploration opportunity evaluation, the technical de risking of prospects, portfolio analysis and managing the interface between exploration and well engineering activities. Unparalleled knowledge of the oil and gas basins of the world, and of different operating regimes and contractual structures, ranging from Alaska, Gulf of Mexico and Brazil, through to the Middle East, former Soviet Union, Far East and Australia. Safety: Following an unsatisfactory audit, became accountable for safety performance in Shell's exploration new ventures. Through personal advocacy and leadership of a small team, delivered pragmatic and effective HSE systems, tools and staff training / engagement and a dramatically improved safety record. R&D: Experience in the 3 key roles in R&D: scientific researcher, research manager, and 'customer' for R&D products. After re-defining Shell's exploration R&D strategy, led the re-structuring of the R&D organization, its interface with 'the business' and approaches to deployment and commercialization. Strategy: Accomplished at formulating competitive strategies in business, R&D and technology deployment, translating them into actionable tactics and results. Defined the exploration strategy of PDO (a Shell subsidiary in Oman) and latterly of Shell's global exploration programme. Professional education, behavioural/motivational coaching: Experienced in organisational re-design, change management, leadership education and talent development. Commercial skills: Personally negotiated drilling compensation claims, educational contracts and E&P contracts, with values of $5 million to $100+ million. 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 about post training coaching support and fees applicable for this. Accreditions And Affliations

P600 is an introductory one-day LEV course

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