69.00€
This course is created to introduce the types of the procedures for registration of medicinal products 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 registration process of the medicinal products.
Student will learn what is the legal basis of the process of registration of medicinal products in the European Union/EEA countries and will get knowledge what kind of guidelines are available for Applicants to proceed with submission easily.
After presentation Student will get basic information about National Procedure, Mutual Registration Procedure, Repeat Use Procedure, Decentralised Procedure and Centralised procedure and will be aware about the differences between them and will be able to answer below questions for each of the procedures:
In addition, the following topics are also covered in the course:
All information presented in this course will help a new employee actively participate in pending registration procedures but also assist in planning of new product registration strategy.
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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