102 Drug Safety courses

Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.

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

This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.

Are you fascinated by the inner workings of drugs and the process of getting them to market? Do you have a passion for pharmacology and want to gain a deep understanding of drug development and regulation processes? Our comprehensive Pharmacology course is the perfect fit for you! Unlock the secrets of drug development and regulation with our Pharmacology course. From fundamental principles to neuropharmacology and chemotherapy, gain a deep understanding of drug development and regulation processes. Learning outcomes: Gain a strong foundation in fundamental principles of pharmacology Understand the process of drug development and regulation Explore the applications of pharmacology in neurology, cardiology, endocrinology, chemotherapy, and immune pharmacology Develop an understanding of inflammation and immune pharmacology Acquire knowledge of the effects of drugs on the cardiovascular system and endocrine system Develop an understanding of the fundamental principles of toxicology Our comprehensive Pharmacology course offers a deep dive into the fundamental principles of pharmacology, drug development, and regulation. The course is designed to provide students with an understanding of the mechanisms of drug action, as well as the regulations governing drug development and approval. Students will explore the applications of pharmacology in various fields such as neurology, cardiology, endocrinology, chemotherapy, immune pharmacology, and toxicology. They will also learn about the impact of drugs on the cardiovascular and endocrine systems. The course is designed to equip students with the knowledge and skills required to enter the field of pharmacology. Our experienced faculty, coupled with a rich course curriculum, ensures that students gain a comprehensive understanding of the subject matter. Certification Upon completion of the course, learners can obtain a certificate as proof of their achievement. You can receive a £4.99 PDF Certificate sent via email, a £9.99 Printed Hardcopy Certificate for delivery in the UK, or a £19.99 Printed Hardcopy Certificate for international delivery. Each option depends on individual preferences and locations. CPD 10 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Students interested in pursuing a career in pharmacology Healthcare professionals seeking to expand their knowledge of pharmacology Anyone looking to gain an understanding of drug development and regulation processes Students pursuing a degree in pharmacology, medicine, or related fields Career path Pharmacologist (average salary of £33,000-£65,000 per year) Pharmaceutical Scientist (average salary of £20,000-£60,000 per year) Clinical Research Associate (average salary of £28,000-£45,000 per year) Toxicologist (average salary of £25,000-£50,000 per year) Regulatory Affairs Officer (average salary of £30,000-£50,000 per year) Drug Safety Associate (average salary of £25,000-£40,000 per year)

Dive into the critical realm of 'Infection Control & Medicine Handling' and unlock the secrets to ensuring safety and optimal medical care. This course navigates through the meticulous processes of drug administration, right from the preparatory stages, ensuring you grasp the vital policies that underpin these practices. Delve deep into the potential perils and side effects of medicines, and learn the essential methods of storage, distribution, and disposal. Furthermore, embrace the nuances of infection prevention, understanding the hazards and risks, ensuring the highest standards of patient safety and care. Learning Outcomes Comprehend the foundational principles of medicine administration. Understand the preliminary steps required before drug administration. Identify and apply core policies and procedures related to medication. Recognise and respond to the side effects of medicines. Master the techniques of medicine storage, distribution, and safe disposal whilst integrating principles of infection prevention. Why buy this Infection Control & Medicine Handling course? Unlimited access to the course for forever Digital Certificate, Transcript, student ID all included in the price Absolutely no hidden fees Directly receive CPD accredited qualifications after course completion Receive one to one assistance on every weekday from professionals Immediately receive the PDF certificate after passing Receive the original copies of your certificate and transcript on the next working day Easily learn the skills and knowledge from the comfort of your home Certification After studying the course materials of the Infection Control & Medicine Handling there will be a written assignment test which you can take either during or at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £5.99. Original Hard Copy certificates need to be ordered at an additional cost of £9.60. Who is this Infection Control & Medicine Handling course for? Healthcare practitioners aiming to elevate their knowledge on medication processes. Medical students seeking a comprehensive understanding of drug safety. Care home staff wishing to ensure the wellbeing of their residents. Individuals interested in entering the medical field with a foundational skillset. Safety officers in medical settings aiming to mitigate health hazards. Prerequisites This Infection Control & Medicine Handling does not require you to have any prior qualifications or experience. You can just enrol and start learning.This Infection Control & Medicine Handling was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Career path Healthcare Administrator: £25,000 - £35,000 Clinical Nurse Specialist: £31,000 - £44,000 Pharmaceutical Distributor: £20,000 - £28,000 Medical Safety Officer: £28,000 - £40,000 Care Home Manager: £30,000 - £42,000 Infection Control Nurse: £29,000 - £39,000 Course Curriculum Module 01: Administration of Medicines Administration of Medicines 00:14:00 Module 02: Preparation for Administration Preparation for Administration 00:13:00 Module 03: Policies and Procedures Policies and Procedures 00:14:00 Module 04: Side Effects of Medicine Side Effects of Medicine 00:12:00 Module 05: Storage, Distribution and Disposal Storage, Distribution and Disposal 00:13:00 Module 06: Infection Control Infection Control 00:17:00 Module 07: Hazards and Potential Risks Hazards and Potential Risks 00:16:00

>>24 Hours Left! Don't Let the Winter Deals Slip Away - Enrol Now!<< According to recent UK statistics, the pharmaceutical industry is one of the country's most significant sectors, with a contribution of £30.4 billion to the economy in the previous year. It's also the UK's largest exporter of goods, with over £50 billion worth of exports in the past recent year. These figures demonstrate the growing importance of this industry and highlight the opportunities for professionals in the field. This Diploma in Pharmacology at QLS Level 4 course is endorsed by The Quality Licence Scheme and accredited by CPD (with 120 CPD points) to make your skill development & career progression more accessible than ever! Our Pharmacology Training course covers a wide range of topics, providing you with a solid foundation in the principles of pharmacology, drug development, and regulation. You'll also gain specialised knowledge in areas such as neuropharmacology, cardiovascular pharmacology, endocrine pharmacology, chemotherapy, inflammation, immune pharmacology, and toxicology. By the end of the Pharmacology Training course, you'll be equipped with the knowledge and skills needed to pursue a variety of roles in the pharmaceutical industry. You'll be able to apply your expertise to develop new drugs, ensure the safety and efficacy of existing medications, and contribute to advancements in medical science. Our Pharmacology Training course offers a valuable stepping stone towards a fulfilling and rewarding career in pharmacology. After this Pharmacology Training course, you will be able to learn: Understand fundamental principles of pharmacology and drug development Analyze the regulation of drugs in the UK Evaluate the pharmacological effects on the nervous system and cardiovascular system Demonstrate knowledge of endocrine pharmacology and chemotherapy Understand the role of inflammation and immune pharmacology in disease Evaluate the impact of toxicology on the pharmaceutical industry Take a step toward a brighter future! Why Prefer this Pharmacology Training Course? Opportunity to earn a certificate endorsed by the Quality Licence Scheme and another certificate accredited by CPDQS. Get a free student ID card! (£10 postal charge will be applicable for international delivery) Innovative and engaging content. Free assessments 24/7 tutor support. *** Course Curriculum *** Here is the curriculum breakdown of this Pharmacology course: Module 01: Fundamental Principles of Pharmacology Module 02: Drug Development and Regulation Module 03: Neuropharmacology Module 04: Cardiovascular Pharmacology Module 05: Endocrine Pharmacology Module 06: Chemotherapy Module 07: Inflammation and Immune Pharmacology Module 08: Toxicology Assessment Process We offer an integrated assessment framework to make the process of evaluation and accreditation for learners easier. You have to complete the assignment questions given at the end of the course and score a minimum of 60% to pass each exam. Our expert trainers will assess your assignment and give you feedback after you submit the assignment. After passing the Diploma in Pharmacology at QLS Level 4 exam, you will be able to request a certificate with additional cost that has been endorsed by the Quality Licence Scheme. CPD 120 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This Pharmacology Training course is for: Graduates with a background in life sciences or pharmacology. Professionals in the pharmaceutical industry seeking to enhance their knowledge and skills. Individuals interested in pursuing a career in pharmacology. Requirements You will not need any prior background or expertise to enrol in this course. Career path After completing this Pharmacology Training course, you are to start your career or begin the next phase of your career. Like as: Pharmaceutical Scientist: £30,000 - £50,000 Pharmacologist: £35,000 - £60,000 Drug Safety Specialist: £40,000 - £70,000 Medical Science Liaison: £40,000 - £70,000 Clinical Research Associate: £25,000 - £45,000 Regulatory Affairs Officer: £30,000 - £60,000 Certificates CPD Accredited Certificate Digital certificate - £10 Diploma in Pharmacology at QLS Level 4 Hard copy certificate - £99 After successfully completing the Diploma in Pharmacology at QLS Level 4, you can order an original hardcopy certificate of achievement endorsed by the Quality Licence Scheme. The certificate will be home-delivered, with a pricing scheme of - 99 GBP inside the UK 109 GBP (including postal fees) for international delivery CPD Accredited Certificate 29 GBP for Printed Hardcopy Certificate inside the UK 39 GBP for Printed Hardcopy Certificate outside the UK (international delivery)

Foundation Level training course is for people working with Children and Young People who are victims of County Lines abuse.

This course raises awareness of the issue of drug misuse in Children and Young People. It will provide learners with knowledge about substances and how they affect those under the influence of them.

Level 4 Diploma(FREE QLS Endorsed Certificate)| 11 CPD Courses+11 PDF Certificates| 220 CPD Points|CPD & CiQ Accredited

Come to Knight Training to get your Drugs Awareness Course! This award consists of 3 units: Drugs Awareness, Drug Use on Licensed Premises and Combating Drug Use on Licensed Premises and is perfect for any staff member that works in a hospitality business.