Description: Rules and guidelines help the decision-making process in regulatory affairs. It is more convenient when they are universal and applicable to multiple situations. However, when there are different requirements, things get complicated. When it comes to Europe, specific regulatory challenges exist in the non-EU countries, especially in countries of the SEE region where health agencies are recently established. This session will identify the main challenges of the regulatory system in the non-EU countries of the SEE region, focusing on procedures of registration of the new medicinal product, marketing authorization renewals and variation submissions. Also, this session will discuss strategic approaches to overcoming these challenges and ensuring no current issues is present to such an extent. These steps can be applied within country-specific environments and used as a starting point for successful goal setting.
Learning Objectives:
Evaluate the regulatory system in different countries.
Identify the main challenges of the regulatory system in the non-EU countries of the SEE region.
List the possible strategies to harmonize regulatory standards in order to facilitate information exchange and market access.
