Product Description
Learning outcomes module 5:
5A Critically review the current EU regulatory requirements (pre and post-authorisation) for a medicinal product
5B Critically evaluate the pharmacovigilance of a medicinal product and the role of the various stakeholders
5C Discuss the various aspects of shortages of medicines and the role the different stakeholders
5D Discuss the role and importance of Regulatory Agencies and other stakeholders in particular patients/patient organizations throughout the lifecycle of a medicinal product
5E Describe the provisions of (1) off label use (2) compassionate use and (3) controlled medicinal products at a national and EU level
5F Outline the legislative background and review processes product information
5G Explain the role of different organizations in the development and implementation of regulatory legislation in Europe
5H Critically discuss treatment compliance and comprehension
5I Locate and navigate regulatory agencies’ websites and sources of information on medicinal product interactions
