7114 Medicine & Nursing courses in Amersham delivered On Demand

Changes to the terms of marketing authorisations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the composition of products, their manufacturing processes, the way they are used, or the indications for which they are authorised. Common approaches are adopted within the European Economic Area to variations to marketing authorisations approved through the Centralised, Decentralised or Mutual Recognition Procedures. Recent legislation has substantially modified the regulatory requirements and extended them to purely national authorisations by member states. This module, which is fully up to date with the new legislation, covers the classification of variations into their several types and the regulatory requirements, guidance and procedures to be followed for each type.

The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.

This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review.

This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP.

his module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the MRP.

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.

3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | 10 CPD Courses | Lifetime Access | 24/7 Tutor Support

Level 7, 5 & 3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 10 CPD Courses | Lifetime Access

Description Basic Electricity Diploma Introducing the Basic Electricity Diploma, an expertly designed online course crafted to impart foundational knowledge and skills surrounding the realm of electricity. This course is tailored to meet the ever-evolving needs of individuals seeking to understand the core principles of electricity, from its safe application to advanced troubleshooting techniques. Every budding electrician, enthusiast, or professional aiming to refresh their knowledge should consider the Basic Electricity Diploma as an essential stepping stone. The content is not just a compilation of theory; it aims to prepare the learner for real-world application. The course starts with a pivotal module on Electrical Safety. Ensuring safety is not just a protocol, but a crucial part of working with electricity. This module ensures that students understand the fundamental safety protocols and potential hazards to be mindful of when working with electrical systems. Understanding the pathways electricity takes is vital. Circuit Analysis will provide learners with knowledge about how circuits function, the different components within them, and the importance of each in a fully functional system. Ever wondered about the motors that power so many of our daily appliances? The section on Electric Motors demystifies this by breaking down their functioning, types, and applications. Simultaneously, the Electrical Power Distribution Systems module introduces learners to the intricate systems in place to deliver electricity from its source to our homes and businesses. The distinction between AC and DC Circuits is foundational to anyone in the electrical field. This course ensures a thorough grasp of both, detailing their individual characteristics, benefits, and applications. Transformers and Capacitors play pivotal roles in the world of electricity. This section of the Basic Electricity Diploma discusses their functionality, importance, and the fundamental physics behind them. With the fast-paced technological advancements, Electrical Control Systems have become more sophisticated and intricate. This module covers the basics of these systems, offering insight into their operation and real-world application. No course on electricity would be complete without discussing the various Electrical Machines and Devices. This module provides an introduction to the most common machines and devices, from generators to common household appliances, shedding light on their workings. Adhering to the right guidelines is paramount. The Electrical Code and Standards module enlightens learners about the critical standards, both national and international, ensuring that all electrical work aligns with the highest levels of safety and quality. Lastly, the Troubleshooting Electrical Systems unit empowers learners with the skills and knowledge to diagnose and rectify common electrical issues, making them an invaluable asset in any electrical role. To sum it up, the Basic Electricity Diploma is a comprehensive online course designed to provide a robust foundation in electricity. From fundamental safety protocols to advanced topics like troubleshooting, this course covers it all, making it a must-have for anyone eager to embark on or advance their journey in the electrical domain. Equip yourself with the knowledge you need and take your electrical understanding to the next level. Register today! What you will learn 1:Electrical Safety 2:Circuit Analysis 3:Electric Motors 4:Electrical Power Distribution Systems 5:AC and DC Circuits 6:Transformers and Capacitors 7:Electrical Control Systems 8:Electrical Machines and Devices 9:Electrical Code and Standards 10:Troubleshooting Electrical Systems Course Outcomes After completing the course, you will receive a diploma certificate and an academic transcript from Elearn college. Assessment Each unit concludes with a multiple-choice examination. This exercise will help you recall the major aspects covered in the unit and help you ensure that you have not missed anything important in the unit. The results are readily available, which will help you see your mistakes and look at the topic once again. If the result is satisfactory, it is a green light for you to proceed to the next chapter. Accreditation Elearn College is a registered Ed-tech company under the UK Register of Learning( Ref No:10062668). After completing a course, you will be able to download the certificate and the transcript of the course from the website. For the learners who require a hard copy of the certificate and transcript, we will post it for them for an additional charge.

Description Basic Chemistry Diploma Understanding the intricacies of chemistry can open up a world of possibilities. Whether one seeks foundational knowledge or plans to further their career in a scientific field, the Basic Chemistry Diploma online course offers a comprehensive introduction to the fundamental principles of chemistry. From exploring the nature of matter and energy to understanding the role of acids and bases in various reactions, this course is designed to provide students with an in-depth overview of essential chemistry concepts. The Basic Chemistry Diploma offers a structured, user-friendly, and interactive online learning experience. It's an excellent choice for those who wish to understand the basics of chemistry without the need for attending traditional classes. By choosing this online course, students can study at their own pace, allowing flexibility and convenience. One of the initial topics covered in this course is Matter and Energy. Here, students learn about the properties and changes of matter, differentiating between physical and chemical properties. The understanding of matter's relationship with energy offers a foundation for more advanced topics in chemistry. The Periodic Table serves as a pivotal tool in chemistry, guiding students on the elements' relationships and their properties. In this segment of the Basic Chemistry Diploma, learners will grasp the organisation and significance of this table. They'll also uncover the mysteries of atomic structure and the periodic trends that dictate element behaviours. Nuclear Chemistry, another vital component of this course, deals with radioactive decay, nuclear fission, and fusion. Through these lessons, students gain insights into the forces holding the nucleus together and the applications of nuclear chemistry in our daily lives. Ionic Bonding and Covalent Bonding are two key aspects of chemical bonding. This course explains the differences and similarities between these bonding types, offering a clear view of how atoms combine to form compounds. As they progress, students will understand how various elements react with each other and the forces at play. In the Chemical Reactions section, students will learn about the different types of reactions, from synthesis to decomposition. They'll also explore how these reactions are balanced and the factors influencing reaction rates. Electrochemistry: Using Electrons presents a world where electrons play a central role. Here, students explore the flow of electrons in chemical reactions, touching on redox reactions and the applications of electrochemistry. Measuring Substances with the Mole ensures students become adept at quantifying substances in chemical reactions. This unit introduces the mole concept, an essential tool in determining substances' amounts in various reactions. Solutions are ubiquitous in the world of chemistry. By delving into this topic, students learn about solute-solvent interactions, the properties of solutions, and the factors affecting solubility. Lastly, the course rounds off with Acids and Bases. Students discover the properties of these substances, how they interact, and their role in various chemical reactions. In summary, the Basic Chemistry Diploma online course is a comprehensive introduction to chemistry's foundational concepts. With its engaging content, it offers learners a convenient and effective way to build a strong chemistry foundation. Whether one is a novice looking to understand the basics or a professional aiming to brush up on fundamental concepts, this course provides the knowledge and skills needed for success. Don't miss this opportunity to unlock the captivating world of chemistry. Register today and start your journey of discovery! What you will learn 1:Matter and Energy 2:Periodic Table 3:Nuclear Chemistry 4:Ionic Bonding 5:Covalent Bonding 6:Chemical Reactions 7:Electrochemistry: Using Electrons 8:Measuring Substances with the Mole 9:Solutions 10:Acids and Bases Course Outcomes After completing the course, you will receive a diploma certificate and an academic transcript from Elearn college. Assessment Each unit concludes with a multiple-choice examination. This exercise will help you recall the major aspects covered in the unit and help you ensure that you have not missed anything important in the unit. The results are readily available, which will help you see your mistakes and look at the topic once again. If the result is satisfactory, it is a green light for you to proceed to the next chapter. Accreditation Elearn College is a registered Ed-tech company under the UK Register of Learning( Ref No:10062668). After completing a course, you will be able to download the certificate and the transcript of the course from the website. For the learners who require a hard copy of the certificate and transcript, we will post it for them for an additional charge.