PTI - international

With the European Union representing the world's second largest market for pharmaceuticals, entering European markets successfully is imperative. European Regulatory Affairs provides a comprehensive introduction to drug registration procedures in the European Union. Topics include an overview of Europe's regulatory framework; the three types of procedures (Centralized, Mutual Recognition and National registration) used for Marketing Authorization Applications; the Common Technical Document; conducting clinical trials in the EU; post-approval regulatory requirements; and future trends to watch out for. Opportunities for interaction with the course instructor and fellow participants are woven throughout the course to enhance your overall learning experience. Following this two-day course, you will return to your job prepared to navigate the European drug registration process and optimize time to market.