The New Drug Application (NDA) is the regulatory vehicle through which sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for marketing and sale in the USA.
This module aims to provide you with effective strategies for the preparation and conduct of a clinical trial, while adhering to regulatory safety standards. Management of data for submission is also covered.
A four-hour workshop for HR Professionals in the area of Attraction, Selection and Recruitment of Neurodiverse people.
This workshop is designed to support staff and organisations in the voluntary, community, and social enterprises (VCSEs) to consider, plan, and implement personal and professional boundaries in the workplace.
The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.