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 to 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.
- ICH guidelines and WHO standards
- EU clinical trials regulation 536/2014
- Main ethical issues and misconduct pitfalls
- Overview of the regulations in the non-European areas
- FDA regulations overview
- IND and NDA procedure at the FDA
Who should attend?
Anyone with first experience in the pharmaceutical industry would benefit from the MasterClass, especially
- Pharmacovigilance experts
- Clinical trials experts
- Clinical research associates
- Regulatory affairs