The expansion of global markets has resulted in increasing regulatory demands for the pharmaceutical industry. Many pharmaceutical companies are expanding their activities to new markets and regions. During this process, companies are facing challenges of coping and keeping compliant with diverse regulatory requirements and operating standards when it comes to Clinical trials and post-marketing requirements during the drug development process.
During this training, we will discuss the differences between these countries and the European Economic Area (EEA) in terms of pharmaceutical legislation. The international harmonization efforts and global collaboration as also the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines are going also to be discussed.