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:
- Who participates in the procedure and who leads the procedure?
- What products apply to a given procedure and how long does the procedure take?
- Which authority issues the Marketing Authorization?
In addition, the following topics are also covered in the course:
- what steps should be taken by the applicant before the registration application submission
- the possible connection and correlation between National Procedure and Mutual Recognition Procedure
- how to add new countries to existing European procedure
- special types of medicinal products that might be registered only by dedicated registration procedure
- few types of Marketing Authorisation that might be issued by the competent Authority
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.
