Module 5: Regulatory Affairs

Abstract

The module Regulatory Affairs covers different areas of pharmaceutical sciences and legislation in Switzerland, the EU and, where appropriate, in other markets such as the US one. It provides knowledge about the marketing authorisation processes and the contents of regulatory documentation. It offers insight into regulatory strategies and reimbursement processes.

Objective

The student acquires the ability to anticipate problems, analyse complex situations, and offer an optimal strategy for achieving marketing authorisation approvals in a timely manner and maintain marketing authorisations over the whole life-cycle of a medicinal product. The student knows and understands how to comply with the current regulatory requirements, how to follow different regulatory steps and how to identify the chemical/ pharmaceutical, preclinical and clinical data required for the marketing authorisation application, taking into account the interaction between the various parts of a dossier. The student can define interactions between the company and the competent health authority as well as interactions between different regulated fields within the company.

Content

Overview of the pharmaceutical legislation, industry issues of large as well as small and medium-sized enterprises (SMEs) and obligation of health authorities. Introduction into regulatory intelligence. Overview of different kinds of pharmaceuticals (e.g. borderline products, generics, biotechnological products) and their different regulatory issues. Overview of processes and applications for marketing authorisation with emphasis on Switzerland and EU and where appropriate on US. Content management and critical evaluation of scientific issues and implications in the documentation for drug development, chemistry and pharmacy, preclinic and clinic for new marketing authorisations of a medicinal product as well as maintaining marketing authorisations during its life-cycle. Introduction into the understanding of a national reimbursement process and application. Strategic planning of the regulatory process.

Resources