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Process Safety Management & Engineering Applications

By EnergyEdge - Training for a Sustainable Energy Future

About this Training Course This 5 full-day course covers all the main elements of IChemE's Process Safety Competency framework: culture, knowledge and competence, engineering and design, human factors, systems and procedures, and assurance. Participants will achieve at least the second level of competence 'Basic Application', which is defined as 'Performs fundamental and routine tasks. Requires occasional supervision. Increased functional expertise and ability. Works with others.' This course examines the interrelation of the various techniques of process safety for analysing and managing process hazards in the hydrocarbon and chemical processing industries. There is a particular emphasis on engineering design aspects with extensive participation in individual and group exercises, tutored exercises and video case studies throughout the course to underpin key learning points. The learning is consolidated in a comprehensive case study and requires collaboration between members of each syndicate. This course has been reviewed and approved by the Institution of Chemical Engineers. IChemE is the global professional membership organisation for chemical, biochemical and process engineers and other professionals involved in the chemical, process and bioprocess industries. Their knowledge of professional standards, close involvement with industry, education and regulators, and their expertise as a leading global training provider, means they are uniquely positioned to independently assess and approve training courses and professional development programmes across the world. Training Objectives By the end of this course, participants will be able to: Acquire the underpinning knowledge required to achieve process safety competency Gain a comprehensive understanding of process safety management Understand the concept of the safety life cycle of a process plant from conceptual design onwards including operation, maintenance and modification Understand the hazard scenarios associated with a process plant Understand how risks can be controlled by hardware and procedural measures Identify and analyse hazard causes and consequences Recognise when specialist analytical expertise is required Generate effective and appropriate measures to reduce risks Justify and communicate practical solutions to non-technical personnel Explain the rationale for process safety measures to decision makers Target Audience This course is suitable for process industry professionals who need to acquire a comprehensive understanding of process safety management, those moving into process safety positions or those who wish to broaden their process safety knowledge within their existing discipline. It is particularly suited for anyone involved in the design, operation, modification or maintenance of a major hazard installation. This includes: Supervisors, operators and maintainers in Oil & Gas, Petrochemical and Chemical industries, process, mechanical and chemical engineers and technicians Design engineers, project engineers and HSE managers Control, automation and instrumentation engineers It will also demonstrate a substantial understanding of process safety for those engaged in Continuous Professional Development or aiming for the Chartered Engineer status. Course Level Basic or Foundation Trainer Your expert course leader has 50 years' experience in chemical and process safety engineering. His early career included 20 years in design and project engineering with various fine chemical and pharmaceutical companies where he designed chemical processes, specified plant equipment and selected materials for highly corrosive and toxic processes, often where textbook data was not available. This was followed by 10 years in offshore oil and gas design projects where he was responsible for setting up a Technical Safety group to change design safety practices in the aftermath of the 1988 Piper Alpha disaster. In recent years, he has been called upon to conduct various offshore and onshore incident investigations. His career has given him experience in project engineering, project management, process design and operations, safety engineering and risk management. He is a Fellow of the UK Institution of Chemical Engineers. He served on the Scottish Branch committee, and was elected chairman for a two-year term in 1991. He has also been chairman of the Safety and Reliability Society - North of Scotland Branch. He has delivered training courses in Process Hazard Analysis (HAZOP and HAZID), Process Safety Management, Hazard Awareness, Risk Assessment, Root Cause Analysis, Failure Modes & Effect Analysis and has lectured on Reliability Analysis to the M.Sc. course in Process Safety and Loss Prevention at Sheffield University. In addition to delivering training courses, he currently facilitates HAZOP / HAZID / LOPA studies and undertakes expert witness roles advising lawyers engaged in contractual disputes, usually involving the design or construction of chemical plants or Oil & Gas production facilities, or criminal prosecutions. 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

Process Safety Management & Engineering Applications
Delivered in Internationally or OnlineFlexible Dates
£3,095 to £3,599

Industrial Instrumentation and Modern Control Systems

By EnergyEdge - Training for a Sustainable Energy Future

About this training course This 5 full-day course provide a comprehensive understanding of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, HART protocol, control valves, actuators, and smart technology. This course will focus on maximizing the efficiency, reliability, and longevity of these systems and equipment by providing an understanding of the characteristics, selection criteria, common problems and repair techniques, preventive and predictive maintenance. This course is a MUST for anyone who is involved in the selection, applications, or maintenance of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology because it covers how these systems and equipment operate, the latest maintenance techniques, and provides guidelines and rules that ensure their successful operation. In addition, this course will cover in detail the basic design, operating characteristics, specification, selection criteria, advanced fault detection techniques, critical components and all preventive and predictive maintenance methods in order to increase the reliability of these systems andequipment and reduce their operation and maintenance cost This course will provide the following information for modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology: Basic Design Specification Selection Criteria Sizing Calculations Enclosures and Sealing Arrangements Codes and Standards Common Operational Problems All Diagnostics, Troubleshooting, Testing, and Maintenance Practical applications of smart instrumentation, SCADA, and Distributed Control Systems, control valves, actuators, etc in the following industries will be discussed in detail: Chemical and petrochemical Power generation Pulp and paper Aerospace Water and sewage treatment Electrical power grids Environmental monitoring and control systems Pharmaceutical plants Training Objectives Equipment Operation: Gain a thorough understanding of the operating characteristics of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Equipment Diagnostics and Inspection: Learn in detail all the diagnostic techniques and inspections required of critical components of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Equipment Testing: Understand thoroughly all the tests required for the various types of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Equipment Maintenance and Troubleshooting: Determine all the maintenance and troubleshooting activities required to minimize the downtime and operating cost of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Equipment Repair and Refurbishment: Gain a detailed understanding of the various methods used to repair and refurbish modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Efficiency, Reliability, and Longevity: Learn the various methods used to maximize the efficiency, reliability, and longevity of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Equipment Sizing: Gain a detailed understanding of all the calculations and sizing techniques used for modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Design Features: Understand all the design features that improve the efficiency and reliability of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Equipment Selection: Learn how to select modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology by using the performance characteristics and selection criteria that you will learn in this course Equipment Enclosures and Sealing Methods Learn about the various types of enclosures and sealing arrangements used for modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Equipment Commissioning: Understand all the commissioning requirements for modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Equipment Codes and Standards: Learn all the codes and standards applicable for modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Equipment Causes and Modes of Failure: Understand the causes and modes of failure of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology System Design: Learn all the requirements for designing different types of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Target Audience Engineers of all disciplines Managers Technicians Maintenance personnel Other technical individuals Training Methods Your specialist course leader relies on a highly interactive training method to enhance the learning process. This method ensures that all participants gain a complete understanding of all 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 to their own organization. Each delegate will receive a copy of the following materials written by the instructor: Industrial Instrumentation and Modern Control Systems Practical Manual (400 pages) Trainer Your specialist course leader has more than 32 years of practical engineering experience with Ontario Power Generation (OPG), one of the largest electric utility in North America. He was previously involved in research on power generation equipment with Atomic Energy of Canada Limited at their Chalk River and Whiteshell Nuclear Research Laboratories. While working at OPG, he acted as a Training Manager, Engineering Supervisor, System Responsible Engineer and Design Engineer. During the period of time, he worked as a Field Engineer and Design Engineer, he was responsible for the operation, maintenance, diagnostics, and testing of gas turbines, steam turbines, generators, motors, transformers, inverters, valves, pumps, compressors, instrumentation and control systems. Further, his responsibilities included designing, engineering, diagnosing equipment problems and recommending solutions to repair deficiencies and improve system performance, supervising engineers, setting up preventive maintenance programs, writing Operating and Design Manuals, and commissioning new equipment. Later, he worked as the manager of a section dedicated to providing training for the staff at the power stations. The training provided by him covered in detail the various equipment and systems used in power stations. In addition, he has taught courses and seminars to more than four thousand working engineers and professionals around the world, specifically Europe and North America. He has been consistently ranked as 'Excellent' or 'Very Good' by the delegates who attended his seminars and lectures. He written 5 books for working engineers from which 3 have been published by McGraw-Hill, New York. Below is a list of the books authored by him; Power Generation Handbook: Gas Turbines, Steam Power Plants, Co-generation, and Combined Cycles, second edition, (800 pages), McGraw-Hill, New York, October 2011. Electrical Equipment Handbook (600 pages), McGraw-Hill, New York, March 2003. Power Plant Equipment Operation and Maintenance Guide (800 pages), McGraw-Hill, New York, January 2012. Industrial Instrumentation and Modern Control Systems (400 pages), Custom Publishing, University of Toronto, University of Toronto Custom Publishing (1999). Industrial Equipment (600 pages), Custom Publishing, University of Toronto, University of Toronto, University of Toronto Custom Publishing (1999). Furthermore, he has received the following awards: The first 'Excellence in Teaching' award offered by PowerEdge, Singapore, in December 2016 The first 'Excellence in Teaching' award offered by the Professional Development Center at University of Toronto (May, 1996). The 'Excellence in Teaching Award' in April 2007 offered by TUV Akademie (TUV Akademie is one of the largest Professional Development centre in world, it is based in Germany and the United Arab Emirates, and provides engineering training to engineers and managers across Europe and the Middle East). Awarded graduation 'With Distinction' from Dalhousie University when completed Bachelor of Engineering degree (1983). Lastly, he was awarded his Bachelor of Engineering Degree 'with distinction' from Dalhousie University, Halifax, Nova Scotia, Canada. He also received a Master of Applied Science in Engineering (M.A.Sc.) from the University of Ottawa, Canada. He is also a member of the Association of Professional Engineers in the province of Ontario, Canada. 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

Industrial Instrumentation and Modern Control Systems
Delivered in Internationally or OnlineFlexible Dates
£3,009 to £3,499

Retrain ONLINE for a Higher-Paying Job in the Pharma Manufacturing Industry in 10-Weeks

By Getreskilled (UK)

Average entry-level pharma roles pay 96% of NHS Band 5 and come with opportunities for overtime, shift allowance and additional benefits as well as huge scope for career progression and salary increases.

Retrain ONLINE for a Higher-Paying Job in the Pharma Manufacturing Industry in 10-Weeks
Delivered Online On Demand
£375 to £4,500

Process Safety Management & Engineering Applications [IChemE Approved Training Course]

By EnergyEdge - Training for a Sustainable Energy Future

Gain expertise in process safety management engineering through EnergyEdge's course. Participate in our classroom training to enhance your skills and knowledge.

Process Safety Management & Engineering Applications
[IChemE Approved Training Course]
Delivered In-PersonFlexible Dates
£3,099 to £3,199

Process Hazard Assessment using the HAZOP Technique and HAZOP Team Leader Training [IChemE Approved Training Course]

By EnergyEdge - Training for a Sustainable Energy Future

Develop your expertise in process hazard assessment and lead HAZOP teams effectively with EnergyEdge's classroom training course. Enroll now!

Process Hazard Assessment using the HAZOP Technique and HAZOP Team Leader Training [IChemE Approved Training Course]
Delivered In-PersonFlexible Dates
£3,099 to £3,199

Advanced Process Safety Engineering

By EnergyEdge - Training for a Sustainable Energy Future

Enhance your knowledge in process safety engineering with EnergyEdge's advanced classroom training course. Register now to secure your spot!

Advanced Process Safety Engineering
Delivered In-PersonFlexible Dates
£3,099 to £3,199

Layer of Protection Analysis (LOPA)

By EnergyEdge - Training for a Sustainable Energy Future

Take your knowledge to the next level with EnergyEdge course on Layer of Protection Analysis (LOPA). Enroll now to advance your career.

Layer of Protection Analysis (LOPA)
Delivered In-PersonFlexible Dates
£2,299 to £2,399

Layer of Protection Analysis (LOPA)

By EnergyEdge - Training for a Sustainable Energy Future

Take your knowledge to the next level with EnergyEdge course on Layer of Protection Analysis (LOPA). Enroll now to advance your career.

Layer of Protection Analysis (LOPA)
Delivered in Internationally or OnlineFlexible Dates
£1,799 to £1,899

Pharmaceutical Sales Representative Diploma - CPD Certified

4.5(3)

By Studyhub UK

24 Hour Flash Deal **25-in-1 Pharmaceutical Sales Representative Diploma Mega Bundle** Pharmaceutical Sales Representative Diploma Enrolment Gifts **FREE PDF Certificate**FREE PDF Transcript ** FREE Exam** FREE Student ID ** Lifetime Access **FREE Enrolment Letter ** Take the initial steps toward a successful long-term career by studying the Pharmaceutical Sales Representative Diploma package online with Studyhub through our online learning platform. The Pharmaceutical Sales Representative Diploma bundle can help you improve your CV, wow potential employers, and differentiate yourself from the mass. This Pharmaceutical Sales Representative Diploma course provides complete 360-degree training on Pharmaceutical Sales Representative Diploma. You'll get not one, not two, not three, but twenty-five Pharmaceutical Sales Representative Diploma courses included in this course. Plus Studyhub's signature Forever Access is given as always, meaning these Pharmaceutical Sales Representative Diploma courses are yours for as long as you want them once you enrol in this course This Pharmaceutical Sales Representative Diploma Bundle consists the following career oriented courses: Course 01: Medical Sales Representative Course 02: Pharmaceutical Marketing, Product Development & and Medical Engagement Course 03: Pharmacology Diploma Course 04: Sales Skills Course 05: Advanced Sales and Selling Management Techniques Course 06: Key Account Management (KAM) Certificate Course 07: Medical Terminology Training Course 08: Business Development Manager Course 09: Customer Relationship Management Course 10: Sales Analysis in Excel Course 11: Negotiation Skills Course 12: Product Management for Maximum Sales: Boosting Business Success Course 13: Medical Receptionist Course 14: Human Anatomy, Physiology and Medical Terminology Diploma Course 15: Financial Planning Course 16: Professional Digital Marketing Diploma Course 17: Medical Law Course 18: Healthcare GDPR Certificate Course 19: Essentials of European Medical Device Regulations Course 20: Health Economics and Health Technology Assessment Course 21: International Healthcare Policy Course 22: Social Media Marketing Course Course 23: Marketing Strategies for Business Course 24: Effective Communication Skills Diploma Course 25: Business Networking Skills The Pharmaceutical Sales Representative Diploma course has been prepared by focusing largely on Pharmaceutical Sales Representative Diploma career readiness. It has been designed by our Pharmaceutical Sales Representative Diploma specialists in a manner that you will be likely to find yourself head and shoulders above the others. For better learning, one to one assistance will also be provided if it's required by any learners. The Pharmaceutical Sales Representative Diploma Bundle is one of the most prestigious training offered at StudyHub and is highly valued by employers for good reason. This Pharmaceutical Sales Representative Diploma bundle course has been created with twenty-five premium courses to provide our learners with the best learning experience possible to increase their understanding of their chosen field. This Pharmaceutical Sales Representative Diploma Course, like every one of Study Hub's courses, is meticulously developed and well researched. Every one of the topics is divided into Pharmaceutical Sales Representative Diploma Elementary modules, allowing our students to grasp each lesson quickly. The Pharmaceutical Sales Representative Diploma course is self-paced and can be taken from the comfort of your home, office, or on the go! With our Student ID card you will get discounts on things like music, food, travel and clothes etc. In this exclusive Pharmaceutical Sales Representative Diploma bundle, you really hit the jackpot. Here's what you get: Step by step Pharmaceutical Sales Representative Diploma lessons One to one assistance from Pharmaceutical Sales Representative Diplomaprofessionals if you need it Innovative exams to test your knowledge after the Pharmaceutical Sales Representative Diplomacourse 24/7 customer support should you encounter any hiccups Top-class learning portal Unlimited lifetime access to all twenty-five Pharmaceutical Sales Representative Diploma courses Digital Certificate, Transcript and student ID are all included in the price PDF certificate immediately after passing Original copies of your Pharmaceutical Sales Representative Diploma certificate and transcript on the next working day Easily learn the Pharmaceutical Sales Representative Diploma skills and knowledge you want from the comfort of your home CPD 250 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This Pharmaceutical Sales Representative Diploma training is suitable for - Students Recent graduates Job Seekers Individuals who are already employed in the relevant sectors and wish to enhance their knowledge and expertise in Pharmaceutical Sales Representative Diploma Requirements To participate in this Pharmaceutical Sales Representative Diploma course, all you need is - A smart device A secure internet connection And a keen interest in Pharmaceutical Sales Representative Diploma Career path You will be able to kickstart your Pharmaceutical Sales Representative Diploma career because this course includes various courses as a bonus. This Pharmaceutical Sales Representative Diploma is an excellent opportunity for you to learn multiple skills from the convenience of your own home and explore Pharmaceutical Sales Representative Diploma career opportunities. Certificates CPD Accredited Certificate Digital certificate - Included CPD Accredited e-Certificate - Free CPD Accredited Hardcopy Certificate - Free Enrolment Letter - Free Student ID Card - Free

Pharmaceutical Sales Representative Diploma - CPD Certified
Delivered Online On Demand6 days
£279

A System Approach to Good Pharmacovigilance Practice

By Research Quality Association

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

A System Approach to Good Pharmacovigilance Practice
Delivered In-PersonFlexible Dates
£1,297 to £1,687