10654 Professional Development courses in Ditton delivered On Demand

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 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.

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 course will cover common vehicle reversing accidents and the crucial role played by the banksman. It'll also look at the controls and actions that can reduce the likelihood of such accidents.

This course is aimed at companies who employ users of display screen equipment, or DSE as it's often called and is intended to be completed by those who will be assessing the DSE set ups of employees. DSE is a term that covers a wide range of equipment. If equipment like this is not set up correctly, users are at increased risk from certain disorders.

This course is aimed at users of display screen equipment, or DSE as it's often called. DSE is a term that covers a wide range of equipment. If DSE equipment like this is not set up correctly, users are at increased risk from certain disorders. As an employee, you share the responsibility to keep people safe at work. That means undergoing relevant training and ensuring that rules are followed.

This course is aimed at anyone that works on licensed premises and gives them an overview of key topics relating to UK licencing law, responsibilities and penalties for breaching these. It also looks in detail at the issue of age verification including an interactive element to support learning in this area.

This course starts with an overview of the Government's Prevent strategy, and then looks at some of the reasons people become extremists. It goes on to cover the objectives of the Prevent strategy, how to base your actions on a risk based approach, what to do if you are concerned and much more.