95 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

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

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.

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.

This course is intended to provide you with the information you need to understand and spot the signs of drug and alcohol misuse. It covers the legal and social implications for the individual and for your company if you find out an employee is misusing drugs. This course discusses the law, different types of drugs, and policies that can be put in place to protect yourself, your business and your employees.

DRUG & ALCOHOL AWARENESS - E-LEARNING Course Types  eLearning  Course Durations  30 minutes novice/experience/refresher Course Ratio  Trainee 1:1  Accreditation  Upon successful completion of the course trainees will be issued with a certificate which will be valid for 5 years.  Minimum Age  Suited to age range of 16 years and above  Prerequisites  None  Assessment  E-learning interactive questions and end test  * Introduction to drug and alcohol awareness * Understand alcohol awareness * Understand pharmaceuticals and herbal preparations * Understand Illicit drugs * Review and summarise * Undertake drug and alcohol awareness interactive testing This training course aims to give trainees knowledge and understanding in drug and alcohol awareness and allows trainees to view realistic scenes and be tested on their knowledge retention. From over-the-counter medicines to illicit substances, drug and alcohol misuse accounts for a staggering proportion of deaths, illness and injuries in the workplace and the broader community, costing billions every year.

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.

This Course at a Glance * Identify the potential symptoms and signs of misuse of drugs and alcohol in workplace * Gain knowledge about illegal drugs and their classification in the UK * Understand the effects and impacts of individual illegal drugs * Gain knowledge about the list of illegal drugs available in the UK * Understand the seriousness of alcohol and drug abuse in the UK through various statistics * Know how to implement the 4 step approach to deal with alcohol issues at work * Understand the effect of alcohol abuse on children * Know how to design an effective policy will help to address employees with an addiction problem * Understand the best business practices to reduce alcohol and drug abuse from both personnel and legal perspective * Understand the general duty of business owners and managers in ensuring the welfare of the staff * Learn about the key legislations associated to the misuse of drugs and alcohol * Learn about the current drug treatment services and the further support available for businesses DRUG & ALCOHOL AWARENESS COURSE OVERVIEW Drug and alcohol awareness plays a vital role in helping to treat substance abuse at all levels of society. This comprehensive Drug and Alcohol Awareness Course is designed to equip you with the knowledge of how drugs affect the body, the long and short-term repercussions of substance misuse, and the potential risk factors involved. The course will teach you how to implement a four-stage plan to address any drug and alcohol-related issues, as well as how to establish an effective Drug and Alcohol Policy. Aside from that, the course will look at best business practices in terms of human resources, regulation, identifying indicators of drug abuse, and putting in place workplace drug and alcohol prevention strategies. This Drug and Alcohol Awareness Course further discusses how the Advisory, Conciliation, and Arbitration Service (ACAS) can assist with the establishment of appropriate alcohol and drug policies and related management skills. The increasing global burden of alcohol and drug addiction is making headlines almost every day causing both economic and social meltdown in communities. In England and Wales, 4,561 deaths due to drug poisoning were reported in 2020 (corresponding to a rate of 79.5 deaths per million persons), which is 3.8% more than the number of deaths reported in 2019. (4,393 deaths; 76.7 deaths per million). Moreover, drugs and alcohol cause lost working days and lower productivity, costing the economy up to £6 billion per year. Therefore, it is extremely important for companies to encourage a healthy work environment by teaching supervisors, managers, and employees how to keep the company drug and alcohol-free. Upon successful completion of this course, you will be able to plan a prevention strategy to control substance abuse within the workplace that will reduce risk and create a safer work environment for both the employer and employees concerned. WHO SHOULD TAKE THIS COURSE? Whether you are an employer, manager or supervisor looking to implement an effective drug and alcohol prevention plan within the workplace or simply looking to gain knowledge about drug and alcohol prevention to help those around you, this Drug and Alcohol Awareness Course will set you up with the appropriate credentials to create a positive and risk-free environment around you by reducing drug, alcohol and substance misuse in the UK. ENTRY REQUIREMENTS * There are no academic entry requirements for this Drug & Alcohol Awareness Course Online course, and it is open to students of all academic backgrounds. * However, you are required to have a laptop/desktop/tablet or smartphone and a good internet connection. ASSESSMENT METHOD This Drug and Alcohol Awareness Course assesses learners through multiple choice questions (MCQs). Upon successful completion of each module, learners must answer MCQs to step into the next module. Through the MCQs, it is measured how much a learner could grasp from each section. In the assessment pass mark is 75%. COURSE CURRICULUM Module 1: Statistics and Signs of Misuse Module 2: Illegal Drugs Part 1 Module 3: Illegal Drugs Part 2 Module 4: Alcohol Misuse Module 5: Company Best Practice Part 1 Module 6: Company Best Practice Part 2 Module 7: Company Best Practice Part 3 Module 8: Drug Treatment Services and Further Support RECOGNISED ACCREDITATION CPD CERTIFICATION SERVICE This course is accredited by continuing professional development (CPD). CPD UK is globally recognised by employers, professional organisations, and academic institutions, thus a certificate from CPD Certification Service creates value towards your professional goal and achievement. CPD certificates are accepted by thousands of professional bodies and government regulators here in the UK and around the world. Many organisations look for employees with CPD requirements, which means, that by doing this course, you would be a potential candidate in your respective field. QUALITY LICENCE SCHEME ENDORSED The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. It will give you a competitive advantage in your career, making you stand out from all other applicants and employees.     CERTIFICATE OF ACHIEVEMENT ENDORSED CERTIFICATE FROM QUALITY LICENCE SCHEME After successfully passing the MCQ exam you will be eligible to order the Endorsed Certificate by Quality Licence Scheme. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. It will give you a competitive advantage in your career, making you stand out from all other applicants and employees. There is a Quality Licence Scheme endorsement fee to obtain an endorsed certificate which is £65. CERTIFICATE OF ACHIEVEMENT FROM LEAD ACADEMY After successfully passing the MCQ exam you will be eligible to order your certificate of achievement as proof of your new skill. The certificate of achievement is an official credential that confirms that you successfully finished a course with Lead Academy. Certificate can be obtained in PDF version at a cost of £12, and there is an additional fee to obtain a printed copy certificate which is £35.   FAQS IS CPD A RECOGNISED QUALIFICATION IN THE UK? CPD is globally recognised by employers, professional organisations and academic intuitions, thus a certificate from CPD Certification Service creates value towards your professional goal and achievement. CPD-certified certificates are accepted by thousands of professional bodies and government regulators here in the UK and around the world. ARE QLS COURSES RECOGNISED? Although QLS courses are not subject to Ofqual regulation, they must adhere to an extremely high level that is set and regulated independently across the globe. A course that has been approved by the Quality Licence Scheme simply indicates that it has been examined and evaluated in terms of quality and fulfils the predetermined quality standards. WHEN WILL I RECEIVE MY CERTIFICATE? For CPD accredited PDF certificate it will take 24 hours, however for the hardcopy CPD certificate takes 5-7 business days and for the Quality License Scheme certificate it will take 7-9 business days. CAN I PAY BY INVOICE? Yes, you can pay via Invoice or Purchase Order, please contact us at info@lead-academy.org for invoice payment. CAN I PAY VIA INSTALMENT? Yes, you can pay via instalments at checkout. HOW TO TAKE ONLINE CLASSES FROM HOME? Our platform provides easy and comfortable access for all learners; all you need is a stable internet connection and a device such as a laptop, desktop PC, tablet, or mobile phone. The learning site is accessible 24/7, allowing you to take the course at your own pace while relaxing in the privacy of your home or workplace. DOES AGE MATTER IN ONLINE LEARNING? No, there is no age limit for online learning. Online learning is accessible to people of all ages and requires no age-specific criteria to pursue a course of interest. As opposed to degrees pursued at university, online courses are designed to break the barriers of age limitation that aim to limit the learner's ability to learn new things, diversify their skills, and expand their horizons. WHEN I WILL GET THE LOGIN DETAILS FOR MY COURSE? After successfully purchasing the course, you will receive an email within 24 hours with the login details of your course. Kindly check your inbox, junk or spam folder, or you can contact our client success team via info@lead-academy.org