The first module of the ERA course focuses on understanding the basic structure of the regulatory system. We will discuss topics such as: the evolution of the regulation of medicines in the European Union (EU); the role of the European Medicines Agency (EMA) and national agencies; and the relevant legislative frameworks. Read more...
The second module discusses two important elements of the Common Technical Document (CTD): quality and non-clinical studies. Good manufacturing and distribution practices (GMP and GDP), pharmacology, toxicology and quality by design will be some of the topics discussed here. Read more...
The third module is on clinical studies. We will discuss the clinical part of the Common Technical Document, e.g. how clinical development plans are made; how to interpret clinical data; and how to make a benefit-risk analysis. Read more...
Finally, module D discusses trends and topics on the edge of the pre- and post-marketing environments. These include (current) developments in HTA; pricing and reimbursement; and use of medicines (e.g. adherence, off-label use and safety monitoring). Read more...