Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.
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An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.
To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.
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.
Get ready for an exceptional online learning experience with the Civil Engineering: Architectural Studies, Interior design, Cost Estimation & Surveyingbundle! This carefully curated collection of 30 premium courses is designed to cater to a variety of interests and disciplines. Dive into a sea of knowledge and skills, tailoring your learning journey to suit your unique aspirations. The Civil Engineering: Architectural Studies, Interior design, Cost Estimation & Surveying is a dynamic package, blending the expertise of industry professionals with the flexibility of digital learning. It offers the perfect balance of foundational understanding and advanced insights. Whether you're looking to break into a new field or deepen your existing knowledge, the Civil Engineering: Architectural Studies, Interior design, Cost Estimation & Surveying package has something for everyone. 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Get ready for an exceptional online learning experience with the Textile Engineering Advanced Diplomabundle! This carefully curated collection of 30 premium courses is designed to cater to a variety of interests and disciplines. Dive into a sea of knowledge and skills, tailoring your learning journey to suit your unique aspirations. The Textile Engineering Advanced Diploma is a dynamic package, blending the expertise of industry professionals with the flexibility of digital learning. It offers the perfect balance of foundational understanding and advanced insights. Whether you're looking to break into a new field or deepen your existing knowledge, the Textile Engineering package has something for everyone. As part of the Textile Engineering Advanced Diploma package, you will receive complimentary PDF certificates for all courses in this bundle at no extra cost. Equip yourself with the Textile Engineering bundle to confidently navigate your career path or personal development journey. 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Upon completion of this online Textile Engineering Advanced Diploma bundle, you will gain the following: CPD QS Accredited Proficiency with this Textile Engineering Advanced Diploma bundle After successfully completing the Textile Engineering Advanced Diploma bundle, you will receive a FREE CPD PDF Certificates as evidence of your newly acquired abilities. Lifetime access to the whole collection of learning materials of this Textile Engineering Advanced Diploma bundle The online test with immediate results You can study and complete the Textile Engineering Advanced Diploma bundle at your own pace. Study for the Textile Engineering Advanced Diploma bundle using any internet-connected device, such as a computer, tablet, or mobile device. Each course in this Textile Engineering Advanced Diploma bundle holds a prestigious CPD accreditation, symbolising exceptional quality. The materials, brimming with knowledge, are regularly updated, ensuring their relevance. 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Get ready for an exceptional online learning experience with the Admin, Secretarial & PA + Microsoft Office Skills bundle! This carefully curated collection of 30 premium courses is designed to cater to a variety of interests and disciplines. Dive into a sea of knowledge and skills, tailoring your learning journey to suit your unique aspirations. The Admin, Secretarial & PA + Microsoft Office Skills is a dynamic package, blending the expertise of industry professionals with the flexibility of digital learning. It offers the perfect balance of foundational understanding and advanced insights. Whether you're looking to break into a new field or deepen your existing knowledge, the Admin, Secretarial & PA + Microsoft Office Skills package has something for everyone. As part of the Admin, Secretarial & PA + Microsoft Office Skills package, you will receive complimentary PDF certificates for all courses in this bundle at no extra cost. Equip yourself with the Admin, Secretarial & PA + Microsoft Office Skills bundle to confidently navigate your career path or personal development journey. Enrol today and start your career growth! This Bundle Comprises the Following Admin, Secretarial & PA + Microsoft Office Skills CPD Accredited Courses: Course 01: Microsoft Word Advanced Course 02: Basic PowerPoint Course 03: Microsoft Excel Course 04: New Functions in Microsoft Excel 2021 Course 05: Microsoft Excel: Automated Dashboard Using Advanced Formula, VBA, Power Query Course 06: Microsoft Excel: Excel Sheet Comparison with VBA Course 07: Excel: Top 50 Microsoft Excel Formulas in 50 Minutes! Course 08: Microsoft Excel: Master Power Query in 120 Minutes! 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Upon completion of this online Admin, Secretarial & PA + Microsoft Office Skills bundle, you will gain the following: CPD QS Accredited Proficiency with this Admin, Secretarial & PA + Microsoft Office Skills bundle After successfully completing the Admin, Secretarial & PA + Microsoft Office Skills bundle, you will receive a FREE CPD PDF Certificates as evidence of your newly acquired abilities. Lifetime access to the whole collection of learning materials of this Admin, Secretarial & PA + Microsoft Office Skills bundle The online test with immediate results You can study and complete the Admin, Secretarial & PA + Microsoft Office Skills bundle at your own pace. Study for the Admin, Secretarial & PA + Microsoft Office Skills bundle using any internet-connected device, such as a computer, tablet, or mobile device. Each course in this Admin, Secretarial & PA + Microsoft Office Skills bundle holds a prestigious CPD accreditation, symbolising exceptional quality. 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Get ready for an exceptional online learning experience with the Accounting and Finance Essentials for Managers bundle! This carefully curated collection of 30 premium courses is designed to cater to a variety of interests and disciplines. Dive into a sea of knowledge and skills, tailoring your learning journey to suit your unique aspirations. The Accounting and Finance Essentials for Managers is a dynamic package, blending the expertise of industry professionals with the flexibility of digital learning. It offers the perfect balance of foundational understanding and advanced insights. Whether you're looking to break into a new field or deepen your existing knowledge, the Accounting and Finance Essentials for Managers package has something for everyone. As part of the Accounting and Finance Essentials for Managers package, you will receive complimentary PDF certificates for all courses in this bundle at no extra cost. 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This Bundle Comprises the Following Accounting and Finance Essentials for Managers CPD Accredited Courses: Course 01: Accounting and Finance Course 02: Business Accounting Training Course 03: Finance Principles Course 04: Financial Analysis Course 05: Finance and Budgeting Diploma Course 06: Corporate Finance: Profitability in a Financial Downturn Course 07: Finance: Financial Risk Management Course 08: Financial Wellness: Managing Personal Cash Flow Course 09: Capital Budgeting & Investment Decision Rules Course 10: Financial Statement Analysis Masterclass Course 11: Financial Statements Fraud Detection Training Course 12: Corporate Finance: Working Capital Management Course 13: Internal Audit Skills Diploma Course 14: Presenting Financial Information Course 15: Financial Reporting Course 16: Learn to Read, Analyse and Understand Annual Reports Course 17: Xero Accounting and Bookkeeping Online Course 18: Tax Accounting Diploma Course 19: UK Tax Reforms and HMRC Legislation Course 20: UK Tax Accounting Course 21: Anti Money Laundering (AML) Level 3 Training Course 22: Debt Management - Online Course Course 23: Pension Course 24: Dealing With Uncertainty: Make Budgets and Forecasts Course 25: Raise Money and Valuation for Business Course 26: Career Development Plan Fundamentals Course 27: CV Writing and Job Searching Course 28: Learn to Level Up Your Leadership Course 29: Networking Skills for Personal Success Course 30: Excel: Top 50 Microsoft Excel Formulas in 50 Minutes! What will make you stand out? Upon completion of this online Accounting and Finance Essentials for Managers bundle, you will gain the following: CPD QS Accredited Proficiency with this Accounting and Finance Essentials for Managers bundle After successfully completing the Accounting and Finance Essentials for Managers bundle, you will receive a FREE CPD PDF Certificates as evidence of your newly acquired abilities. Lifetime access to the whole collection of learning materials of this Accounting and Finance Essentials for Managers bundle The online test with immediate results You can study and complete the Accounting and Finance Essentials for Managers bundle at your own pace. Study for the Accounting and Finance Essentials for Managers bundle using any internet-connected device, such as a computer, tablet, or mobile device. Each course in this Accounting and Finance Essentials for Managers bundle holds a prestigious CPD accreditation, symbolising exceptional quality. 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Whether you are just starting your career, looking to switch industries, or hoping to enhance your professional skill set, the Accounting and Finance Essentials for Managers bundle offers you the flexibility and convenience to learn at your own pace. Make the Accounting and Finance Essentials for Managers package your trusted companion in your lifelong learning journey. CPD 300 CPD hours / points Accredited by CPD Quality Standards Who is this course for? The Accounting and Finance Essentials for Managers bundle is perfect for: Lifelong learners looking to expand their knowledge and skills. Professionals seeking to enhance their career with CPD certification. Individuals wanting to explore new fields and disciplines. Anyone who values flexible, self-paced learning from the comfort of home. Requirements You are cordially invited to enroll in this Accounting and Finance Essentials for Managers bundle; please note that there are no formal prerequisites or qualifications required. 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Get ready for an exceptional online learning experience with the Strategic Management, Planning & Entrepreneurship for Entrepreneurs bundle! This carefully curated collection of 30 premium courses is designed to cater to a variety of interests and disciplines. Dive into a sea of knowledge and skills, tailoring your learning journey to suit your unique aspirations. The Strategic Management, Planning & Entrepreneurship for Entrepreneurs is a dynamic package, blending the expertise of industry professionals with the flexibility of digital learning. It offers the perfect balance of foundational understanding and advanced insights. Whether you're looking to break into a new field or deepen your existing knowledge, the Strategic Management, Planning & Entrepreneurship for Entrepreneurs package has something for everyone. As part of the Strategic Management, Planning & Entrepreneurship for Entrepreneurs package, you will receive complimentary PDF certificates for all courses in this bundle at no extra cost. Equip yourself with the Strategic Management, Planning & Entrepreneurship for Entrepreneurs bundle to confidently navigate your career path or personal development journey. Enrol today and start your career growth! This Bundle Comprises the Following Strategic Management, Planning & Entrepreneurship for EntrepreneursCPD Accredited Courses: Course 01: Entrepreneurship: Startup your New Venture Course 02: Fundamentals of Entrepreneurship Course 03: Entrepreneurial Mindset Course 04: Advanced Pitching for Startups Course 05: Business Plan Course 06: Making Budget & Forecast Course 07: Financial Ratio Analysis for Business Decisions Course 08: Business Analysis Course Level 5 Course 09: Strategic Management Course 10: Business Law 2021 Course 11: Leadership and Management Course Course 12: People Management Diploma Course 13: Train the Trainer - Part 1 Course 14: Capital Budgeting & Investment Decision Rules Course 15: Investment Banking: Venture Capital Fundraising for Startups Course 16: Financial Management Course 17: Tax Accounting Course 18: Marketing Course 19: Sales Skills Course 20: Sales Negotiation Training Course Course 21: Increase Your Sales Through a Profitable Pricing Strategy Course 22: Creating Highly Profitable Sales Funnels Course 23: Know Your Customers Course 24: Customer Relationship Management Course 25: Risk Management Course 26: CV Writing and Job Searching Course 27: Learn to Level Up Your Leadership Course 28: Networking Skills for Personal Success Course 29: Career Development Plan Fundamentals Course 30: Excel: Top 50 Microsoft Excel Formulas in 50 Minutes! What will make you stand out? Upon completion of this online Strategic Management, Planning & Entrepreneurship for Entrepreneurs bundle, you will gain the following: CPD QS Accredited Proficiency with this Strategic Management, Planning & Entrepreneurship for Entrepreneurs After successfully completing the Strategic Management, Planning & Entrepreneurship for Entrepreneurs bundle, you will receive a FREE CPD PDF Certificates as evidence of your newly acquired abilities. Lifetime access to the whole collection of learning materials of this Strategic Management, Planning & Entrepreneurship for Entrepreneurs. The online test with immediate results You can study and complete the Strategic Management, Planning & Entrepreneurship for Entrepreneurs bundle at your own pace. Study for the Strategic Management, Planning & Entrepreneurship for Entrepreneursbundle using any internet-connected device, such as a computer, tablet, or mobile device. Each course in this Strategic Management, Planning & Entrepreneurship for Entrepreneurs bundle holds a prestigious CPD accreditation, symbolising exceptional quality. The materials, brimming with knowledge, are regularly updated, ensuring their relevance. This bundle promises not just education but an evolving learning experience. Engage with this extraordinary collection, and prepare to enrich your personal and professional development. Embrace the future of learning with the Strategic Management, Planning & Entrepreneurship for Entrepreneurs, a rich anthology of 30 diverse courses. Each course in the Strategic Management, Planning & Entrepreneurship for Entrepreneurs bundle is handpicked by our experts to ensure a wide spectrum of learning opportunities. ThisStrategic Management, Planning & Entrepreneurship for Entrepreneurs bundle will take you on a unique and enriching educational journey. The bundle encapsulates our mission to provide quality, accessible education for all. Whether you are just starting your career, looking to switch industries, or hoping to enhance your professional skill set, the Strategic Management, Planning & Entrepreneurship for Entrepreneurs bundle offers you the flexibility and convenience to learn at your own pace. Make the Strategic Management, Planning & Entrepreneurship for Entrepreneurs package your trusted companion in your lifelong learning journey. CPD 300 CPD hours / points Accredited by CPD Quality Standards Who is this course for? The Strategic Management, Planning & Entrepreneurship for Entrepreneurs bundle is perfect for: Lifelong learners looking to expand their knowledge and skills. Professionals seeking to enhance their career with CPD certification. Individuals wanting to explore new fields and disciplines. Anyone who values flexible, self-paced learning from the comfort of home. Requirements You are cordially invited to enroll in this Strategic Management, Planning & Entrepreneurship for Entrepreneurs bundle; please note that there are no formal prerequisites or qualifications required. We've designed this curriculum to be accessible to all, irrespective of prior experience or educational background. Career path Unleash your potential with the Strategic Management, Planning & Entrepreneurship for Entrepreneurs bundle. Acquire versatile skills across multiple fields, foster problem-solving abilities, and stay ahead of industry trends. Ideal for those seeking career advancement, a new professional path, or personal growth. Embrace the journey with the Strategic Management & Planning bundle package. Certificates CPD Quality Standard Certificate Digital certificate - Included 30 CPD Accredited Digital Certificates and A Hard Copy Certificate