422 Pharmaceutical courses delivered On Demand

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 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.

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.

Biomedical Science is yet another 'Teacher's Choice' course from Teachers Training for a complete understanding of the fundamental topics. You are also entitled to exclusive tutor support and a professional CPD-accredited certificate in addition to the special discounted price for a limited time. Just like all our courses, this Biomedical Science and its curriculum have also been designed by expert teachers so that teachers of tomorrow can learn from the best and equip themselves with all the necessary skills. Consisting of several modules, the course teaches you everything you need to succeed in this profession. The course can be studied part-time. You can become accredited within 02 Hours studying at your own pace. Your qualification will be recognised and can be checked for validity on our dedicated website. Why Choose Teachers Training Some of our website features are: This is a dedicated website for teaching 24/7 tutor support Interactive Content Affordable price Courses accredited by the UK's top awarding bodies 100% online Flexible deadline Entry Requirements No formal entry requirements. You need to have: Passion for learning A good understanding of the English language Be motivated and hard-working Over the age of 16. Certification CPD Certification from The Teachers Training Successfully completing the MCQ exam of this course qualifies you for a CPD-accredited certificate from The Teachers Training. You will be eligible for both PDF copy and hard copy of the certificate to showcase your achievement however you wish. You can get your digital certificate (PDF) for £4.99 only Hard copy certificates are also available, and you can get one for only £10.99 You can get both PDF and Hard copy certificates for just £12.99! The certificate will add significant weight to your CV and will give you a competitive advantage when applying for jobs. 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

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.

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.

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.

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.

In this course we explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.