Free Level 7 QLS Endorsed Certificate | CPD Accredited | 180 CPD Points | Advanced Learning Materials | Lifetime Access
This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
24 Hour Flash Deal **25-in-1 Advanced Medical Writing Diploma Mega Bundle** Advanced Medical Writing 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 Advanced Medical Writing Diploma package online with Studyhub through our online learning platform. The Advanced Medical Writing Diploma bundle can help you improve your CV, wow potential employers, and differentiate yourself from the mass. This Advanced Medical Writing Diploma course provides complete 360-degree training on Advanced Medical Writing Diploma. You'll get not one, not two, not three, but twenty-five Advanced Medical Writing Diploma courses included in this course. 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The Advanced Medical Writing 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 Advanced Medical Writing Diploma bundle, you really hit the jackpot. Here's what you get: Step by step Advanced Medical Writing Diploma lessons One to one assistance from Advanced Medical Writing Diplomaprofessionals if you need it Innovative exams to test your knowledge after the Advanced Medical Writing Diplomacourse 24/7 customer support should you encounter any hiccups Top-class learning portal Unlimited lifetime access to all twenty-five Advanced Medical Writing Diploma courses Digital Certificate, Transcript and student ID are all included in the price PDF certificate immediately after passing Original copies of your Advanced Medical Writing Diploma certificate and transcript on the next working day Easily learn the Advanced Medical Writing 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 Advanced Medical Writing 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 Advanced Medical Writing Diploma Requirements To participate in this Advanced Medical Writing Diploma course, all you need is - A smart device A secure internet connection And a keen interest in Advanced Medical Writing Diploma Career path You will be able to kickstart your Advanced Medical Writing Diploma career because this course includes various courses as a bonus. This Advanced Medical Writing Diploma is an excellent opportunity for you to learn multiple skills from the convenience of your own home and explore Advanced Medical Writing 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
24 Hour Flash Deal **25-in-1 Medical Secretary Advanced Diploma Mega Bundle** Medical Secretary Advanced 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 Medical Secretary Advanced Diploma package online with Studyhub through our online learning platform. The Medical Secretary Advanced Diploma bundle can help you improve your CV, wow potential employers, and differentiate yourself from the mass. This Medical Secretary Advanced Diploma course provides complete 360-degree training on Medical Secretary Advanced Diploma. You'll get not one, not two, not three, but twenty-five Medical Secretary Advanced Diploma courses included in this course. Plus Studyhub's signature Forever Access is given as always, meaning these Medical Secretary Advanced Diploma courses are yours for as long as you want them once you enrol in this course This Medical Secretary Advanced Diploma Bundle consists the following career oriented courses: Course 01: Medical Secretary Certification Course 02: Medical Transcription Diploma Course 03: Medical Receptionist Course 04: Human Anatomy, Physiology and Medical Terminology Diploma Course 05: Medical Law Course 06: Medical & Clinical Administrator Course 07: Medical coding Training Course 08: Healthcare GDPR Certificate Course 09: Medical Writing Course 10: Consent Training in Healthcare Course 11: Administration of Emergency Medical Gases Course 12: Practice Nurse & Infection Control Training Course 13: Clinical Pharmacy Certificate Program and Professional Standards Course 14: CSTF Patient Moving and Handling: Ensuring Safe Healthcare Practices Course 15: Infection Control Diploma Course 16: Pharmacology Diploma Course 17: Clinical Governance in Adult Care Course 18: Mental Health Awareness and Psychiatric Disorders Course 19: Neuroscience of Brain Disorders Course 20: Research in Adult Care Course 21: Infection Control & Medicine Handling Course 22: Nurse Prescribing and Medicine Management Course 23: Essentials of European Medical Device Regulations Course 24: Health Economics and Health Technology Assessment Course 25: English for Healthcare The Medical Secretary Advanced Diploma course has been prepared by focusing largely on Medical Secretary Advanced Diploma career readiness. It has been designed by our Medical Secretary Advanced 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 Medical Secretary Advanced Diploma Bundle is one of the most prestigious training offered at StudyHub and is highly valued by employers for good reason. This Medical Secretary Advanced 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 Medical Secretary Advanced Diploma Course, like every one of Study Hub's courses, is meticulously developed and well researched. Every one of the topics is divided into Medical Secretary Advanced Diploma Elementary modules, allowing our students to grasp each lesson quickly. The Medical Secretary Advanced 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 Medical Secretary Advanced Diploma bundle, you really hit the jackpot. Here's what you get: Step by step Medical Secretary Advanced Diploma lessons One to one assistance from Medical Secretary Advanced Diplomaprofessionals if you need it Innovative exams to test your knowledge after the Medical Secretary Advanced Diplomacourse 24/7 customer support should you encounter any hiccups Top-class learning portal Unlimited lifetime access to all twenty-five Medical Secretary Advanced Diploma courses Digital Certificate, Transcript and student ID are all included in the price PDF certificate immediately after passing Original copies of your Medical Secretary Advanced Diploma certificate and transcript on the next working day Easily learn the Medical Secretary Advanced 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 Medical Secretary Advanced 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 Medical Secretary Advanced Diploma Requirements To participate in this Medical Secretary Advanced Diploma course, all you need is - A smart device A secure internet connection And a keen interest in Medical Secretary Advanced Diploma Career path You will be able to kickstart your Medical Secretary Advanced Diploma career because this course includes various courses as a bonus. This Medical Secretary Advanced Diploma is an excellent opportunity for you to learn multiple skills from the convenience of your own home and explore Medical Secretary Advanced 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
A one-day training for counsellors, nurses, managers and healthcare practitioners who want to learn how to set up and facilitate Reflective Practice groups. Reflective Practice is the cornerstone of professionalism in healthcare. It develops clinical skills, improves decision-making, enhances work satisfaction, and reduces burnout.
A fabulous four day (3 days face to face and one day virtually) facilitation course for anyone wanting to teach or support people with learning disabilities with sex and relationships. A course participant from September 2022 said: “I wanted to thank you for the training last week. It was enjoyable and invaluable. It's been a while since I funded training myself and the last time I had, I was concerned as it wasn't particularly fulfilling but this was a completely different experience. Thanks to both of you.” Aim: To support participants to develop their current knowledge, skills and confidence to plan, deliver and evaluate relationships and sex education (RSE) sessions to groups and individuals with learning disabilities Learning Outcomes: By the end of the course, participants will have: • considered their work environment in relation to delivering RSE • identified how to assess the relationships and sex needs of the group or individual with learning disabilities • created an inclusive, factually correct, interactive RSE session for a group or an individual with learning disabilities • used a range of resources and exercises to design their session taking into account different learning styles • practised their session with the training participants • delivered a session to a group of their choice and returned to discuss this session with other participants This course is appropriate for teachers, care workers, clinical staff, social workers, SALTs, OTs, anyone working with people with learning disabilities.
This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
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