Regulatory Affairs

Abstract

The module “Drug Regulatory Affairs” provides an overview of current regulations and legislation and their practical application to the development and commercialization of pharmaceutical products in the EU and CH. The module offers insight into regulatory strategies and intelligence and emphasises the increasing importance of regulatory thinking in the pharmaceutical industry.

Objective

• The student is able to explain the role played by regulatory affairs during the development and in obtaining and maintaining marketing authorisations for pharmaceutical products. • The student is able to anticipate problems, analyse complex situations, and to identify 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 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 stakeholders and regulated fields within the company. • The student knows how and where to get drug regulatory affairs relevant information.

Content

• Relevance of drug regulatory affairs in the development and commercialization process of pharmaceutical products in industry. • Overview of the pharmaceutical legislation, industry issues of large as well as small and medium-sized enterprises (SMEs) and obligation of health authorities. • Overview of different pharmaceutical products (e.g. borderline products, generics, biotechnological products) and their different regulatory issues. • Overview of processes and applications for marketing authorisation with emphasis on EU and Switzerland. • Introduction to regulatory intelligence. • Content management and critical evaluation of scientific issues and implications in the documentation for drug development, chemistry, preclinical and clinic for new marketing authorisations of a medicinal product as well as maintaining marketing authorisations during its life-cycle. • Strategic planning of the regulatory process and interaction with internal and external stakeholders.

Resources