Drug Regulatory Affairs in Drug Development

All aspects within the pharmaceutical development process of medicinal products are subject to various degree of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities' attitudes and requirements etc. have a great influence on the drug development process and the success of it. Regulatory affairs professionals deal with these aspects. Knowing this discipline and how to focus the development process and co-operate with the regulatory affairs professionals can be vital for the success of a medicinal product development and so the survival of a pharmaceutical company.
 

The contents will cover the role and responsibility for the drug regulatory affairs professionals – how they are involved in the development process, how to co-operate with this function, the pharmaceutical law frame, the application and approval procedures, regulatory strategic issue, how to build up an application for a marketing authorization, variations, incentives, pharmacovigilance, and how to approach the issues of Quality, Safety, Efficacy and market access from a regulatory point of view.