This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.
The CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. In the European Economic Area, the USA and Canada, the CTD, in its electronic format (eCTD), is mandatory for all applications for marketing approval and all subsequent related submissions. The CTD is accepted in many other countries, being mandatory for new prescription medicines in some. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.
This accredited qualification is ideal for anyone who requires training in conflict management. It is appropriate for a wide range of sectors and is suitable for anyone who has a customer facing role, dealing with service users or the public. It is also a useful qualification for individuals who would like a better understanding of how to prevent conflict situations from arising and feel more confident in being able to deal with situations if they arise. Subjects covered include the role of communication and the assessment of risks in conflict situations and follow up practices after such events. How long will it take me to achieve this qualification? This qualification is usually achieved by taking a 2 day course. How is the qualification assessed? The qualification is assessed through a 1 hour, 30-question, multiple-choice question examination. Candidates must achieve a score of at least 20 out of 30 in order to pass.
This course aims to provide a more in depth understanding of COSHH & RIDDOR.
Free Level 5 QLS Endorsed Certificate | CPD Accredited | 150 CPD Points | Advanced Learning Materials | Lifetime Access
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Navigate the maze of corporate compliance with confidence. Dive into a structured learning journey that unveils the complexities of risk management and aligns you with modern corporate practices. This course not only introduces you to compliance essentials but also ensures you're adept at identifying, analysing, and managing business risks. Equip yourself with a coveted skill set that employers ardently seek. From understanding compliance's fundamental elements to mastering the risk management process, this course is your stepping stone to a prosperous career in corporate governance. Chart your course to become an indispensable asset to any organisation. Learning Outcomes Understand the core concepts of corporate compliance. Identify the five foundational elements of compliance. Master the intricacies of the Compliance Management System. Execute compliance audits with precision. Develop ethical standards for robust compliance. Differentiate and understand various types of risk. Implement effective risk management strategies. Key Features FREE QLS-endorsed certificate 4 Free CPD Accredited Courses with Free e-Certificates CPD Accredited Hard Copy Certificates Fully online, interactive courses Self-paced learning and laptop, tablet, smartphone-friendly 24/7 Learning Assistance Discounts on bulk purchases Free Courses CSR - Corporate Social Responsibility Corporate Governance Anti Money Laundering (Risk-Based Approach, Customer Due Diligence) Corporate Coaching and Mentoring What Will You Learn from This Course? Dive into the intricate world of corporate compliance and risk management. This course unveils the foundational principles of compliance, the essence of risk, and the methods to manage them effectively. Whether you're a budding professional or someone looking to broaden their business understanding, this course is tailored for you. Module 1: Introduction to Compliance Delve into the basics. Understand what compliance means and its role in businesses. Module 2: Five basic elements of compliance Unpack the core components. Learn the crucial elements forming the bedrock of compliance. Module 3: Compliance Management System (CMS) Discover the system. Explore how organisations manage and ensure their compliance. Module 4: Compliance Audit Grasp the audit process. Understand how to review and ensure regulatory adherence. Module 5: Compliance and Ethics Link compliance with morality. Realise the importance of ethics in maintaining compliance. Module 6: Risk and Types of Risk Get to know risk. Classify and comprehend different risk forms impacting businesses. Module 7: Introduction to Risk Management Begin your risk journey. Understand risk management's essence and its significance. Module 8: Risk Management Process Master the method. Learn the steps involved in managing and mitigating risks effectively. Certificate Once you've successfully completed your course, you will immediately be sent a CPD Accredited PDF certificate. Also, you can have your printed certificate delivered by post (shipping cost £3.99). After successfully completing the assignment, learners will be able to order a FREE QLS-endorsed certificate. CPD 10 CPD hours / points Accredited by CPD Quality Standards Who is this course for? New compliance officers seeking foundational knowledge. Risk management aspirants aiming for structured learning. Business students focusing on corporate governance. Company board members enhancing oversight skills. Managers wanting to understand organisational risks. Audit professionals expanding their service offerings. Small business owners ensuring company compliance. Legal advisors updating their knowledge on compliance. Requirements No prior degree or experience is required to enrol in this course. Career path Compliance Officer Risk Management Consultant Corporate Governance Analyst Regulatory Affairs Specialist Compliance Audit Manager Risk Management Coordinator. Certificates CPD Accredited e-Certificate Digital certificate - Included CPD Accredited Hard Copy Certificate Hard copy certificate - Included You will get the hard copy certificates for Free! The delivery charge of the hard copy certificate inside the UK is £3.99 each. QLS Endorsed Certificate Digital certificate - Included
The course covers investigation and risk assessment of asbestos-contaminated soils and sites, including waste classification and land remediation. It will cover the current HSE and EA legislation and guidance, assessing risk to health from asbestos in soils and how to assess the land, analysis types and interpretation, and remedial actions.