329 Courses

This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.

Proactive risk management is a major component of good pharmacovigilance practice. This module sets out the principles of risk management planning and outlines regulatory requirements for risk management plans in regions that are major markets for medicinal products.

A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather than from the applicant’s own studies. The applicant typically proposes to market a drug that is based on an approved reference product but modified in its formulation or uses. A 505(b)(2) NDA also differs from an Abbreviated New Drug Application (ANDA) for approval of a generic drug in that the applicant’s product need not be a duplicate of the reference listed drug. The 505(b)(2) pathway may be said to lie part-way between the ‘stand-alone’ NDA and generics pathways, offering a unique combination of advantages to developers. It facilitates the modification of drugs to address unmet medical needs. The 505(b)(2) application pathway accounts for about half of all new drug approvals in the USA.

This course describes the requirements that must be met by, and options available to, the sponsor during the conduct of an authorised clinical trial. It identifies the various interactions with MSCs that occur via the Clinical Trials Information System (CTIS), and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT11 sets out the European legal and regulatory context for clinical trials and describes how to apply via the CTIS for authorisation to conduct trials. The two courses therefore provide an ideal foundation for understanding and complying with the new law.

This module provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA.