This course is created to introduce the meaning of a data exclusivity and market exclusivity for the reference medicinal product to the new employee of the Regulatory Affairs Department. Course is dedicated to junior specialists or specialists that start their work in pharmaceutical company and have none or very limited experience in area of registration processes of the medicinal products.
Student will learn what is the data exclusivity and market exclusivity for the reference medicinal product and what are the law basis for these exclusivities. In addition it will be explained how to extend the exclusivity period and also examples of shortening of exclusivity period will be presented.
During the course Student will get elementary information also about the reference medicinal product itself.
In the course it will be explained what is the idea of Global Marketing Authorisation, why was it created and when can we use it.
Student will learn how to get the year of data exclusivity for well-established products, what are the rules describing market exclusivity for Orphan medicines and what means the mystery code of 8+2+1.
In case of Orphan medicines some basic rules about these products will be presented as well as the path to the orphan status granting.
As Regulatory Affairs Department members we have impact on the quality of submitted files and our knowledge can support effective and undisturbed regulatory process. All information presented in this course will help a new employee to be better prepared to work with registration of original and generic registration applications. It will be also supportive in case of business discussions and searching of new opportunities.
