402 Pharmaceutical courses delivered Online

Register on the Biomedical Science today and build the experience, skills and knowledge you need to enhance your professional development and work towards your dream job. Study this course through online learning and take the first steps towards a long-term career. The course consists of a number of easy to digest, in-depth modules, designed to provide you with a detailed, expert level of knowledge. Learn through a mixture of instructional video lessons and online study materials. Receive online tutor support as you study the course, to ensure you are supported every step of the way. Get a digital certificate as a proof of your course completion. The Biomedical Science is incredibly great value and allows you to study at your own pace. Access the course modules from any internet-enabled device, including computers, tablet, and smartphones. The course is designed to increase your employability and equip you with everything you need to be a success. Enrol on the now and start learning instantly! What You Get With The Biomedical Science Receive a e-certificate upon successful completion of the course Get taught by experienced, professional instructors Study at a time and pace that suits your learning style Get instant feedback on assessments 24/7 help and advice via email or live chat Get full tutor support on weekdays (Monday to Friday) Course Design The course is delivered through our online learning platform, accessible through any internet-connected device. There are no formal deadlines or teaching schedules, meaning you are free to study the course at your own pace. You are taught through a combination of Video lessons Online study materials Certification After the successful completion of the final assessment, you will receive a CPD-accredited certificate of achievement. The PDF certificate is for £9.99, and it will be sent to you immediately after through e-mail. You can get the hard copy for £15.99, which will reach your doorsteps by post. Who Is This Course For: The course is ideal for those who already work in this sector or are an aspiring professional. This course is designed to enhance your expertise and boost your CV. Learn key skills and gain a professional qualification to prove your newly-acquired knowledge. Requirements: The online training is open to all students and has no formal entry requirements. To study the Biomedical Science, all your need is a passion for learning, a good understanding of English, numeracy, and IT skills. You must also be over the age of 16. Course Content Module 01: Introduction to Biomedical Science Introduction to Biomedical Science 00:30:00 Module 02: Genetics and Biochemistry Genetics and Biochemistry 00:19:00 Module 03: Microbiology and Cell Biology Microbiology and Cell Biology 00:26:00 Module 04: Biochemical Engineering and Enzyme Discovery Biochemical Engineering and Enzyme Discovery 00:19:00 Module 05:Toxicology, Pharmaceuticals and Fine Chemicals Toxicology, Pharmaceuticals and Fine Chemicals 00:17:00 Module 06: Systems and Synthetic Biology Systems and Synthetic Biology 00:16:00 Module 07: Global Health Challenges Global Health Challenges 00:12:00 Frequently Asked Questions Are there any prerequisites for taking the course? There are no specific prerequisites for this course, nor are there any formal entry requirements. All you need is an internet connection, a good understanding of English and a passion for learning for this course. Can I access the course at any time, or is there a set schedule? You have the flexibility to access the course at any time that suits your schedule. Our courses are self-paced, allowing you to study at your own pace and convenience. How long will I have access to the course? For this course, you will have access to the course materials for 1 year only. This means you can review the content as often as you like within the year, even after you've completed the course. However, if you buy Lifetime Access for the course, you will be able to access the course for a lifetime. Is there a certificate of completion provided after completing the course? Yes, upon successfully completing the course, you will receive a certificate of completion. This certificate can be a valuable addition to your professional portfolio and can be shared on your various social networks. Can I switch courses or get a refund if I'm not satisfied with the course? We want you to have a positive learning experience. If you're not satisfied with the course, you can request a course transfer or refund within 14 days of the initial purchase. How do I track my progress in the course? Our platform provides tracking tools and progress indicators for each course. You can monitor your progress, completed lessons, and assessments through your learner dashboard for the course. What if I have technical issues or difficulties with the course? If you encounter technical issues or content-related difficulties with the course, our support team is available to assist you. You can reach out to them for prompt resolution.

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 outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.

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.

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.

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.

This module extends the learner’s understanding of pharmacokinetic and pharmacodynamic studies from the basics described in our companion module PKPD01, An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration. It provides detail on a variety of aspects of such studies: design, sampling, data analysis, research in special populations, and bioequivalence testing.

The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases.