59271 Courses

This course will show you how to create a professional and attractive user interface (UI) in Django for data science using the Semantic UI framework.

Training Course at Parkwood Outdoor Centre for Novice crews on Targa Rallies

Silver Clay Jewellery Class for Beginners. Have fun, learn new skills, and socialise in this beginner’s class! Learn how to create beautiful, hallmark quality sterling silver clay pendants and take home your handmade unique necklace.

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.

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 foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed.

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 design, development and installation phase, the validation phase, and the operation and maintenance phase of the validation of computerised systems in medicines and healthcare products manufacturing environments. It continues to follow the progress of a pharmaceutical company's project to validate a new dispensary control system.

In the medicines and healthcare products industries, computerised systems used in automated manufacturing or laboratory processes to which Good Manufacturing Practice requirements apply need to be validated. This module describes the planning of such validation. It follows the work of a pharmaceutical company's team as they validate the dispensary control system for a new production line.