69.00€
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.
I am Regulatory Affairs Expert with over 11 years of experience in medicinal products registration and maintaining procedures and with understanding the need for close cooperation with medical, pharmacovigilance, marketing and supply departments. I am looking for new opportunities to expand the knowledge in areas connected with lifecycle of the medicinal product and now I am getting to know the area of Pharmacovigilance with all its curiosities. I am deeply convinced that clear and simple communication is very valuable in learning processes so I prepare courses that are based on my experience and I try to show you all the regulatory affairs secrets that I discovered over the years.
I started my adventure with Regulatory Affairs Department in 2010 as Regulatory Affairs Specialist and each year expanded my experience in:
I hope my courses will be interesting, useful, easy to remember and what is most important understandable to you. Good luck!
Warsaw University of Technology
Department of Chemical and Process Engineering
Master’s Degree, Biotechnology in Industry
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