This course is created to introduce the Regulatory Affairs Department to the unexperienced employee. Course is dedicated to junior specialists or specialists that start their work in pharmaceutical company or in Regulatory Affairs Department and have none or very limited experience in registration process of the medicinal products and maintenance of the medicinal products dossier. It presents the helicopter view of activities that might be required on their position and help to reach a big picture of the regulatory affairs department place in the organization and its internal and external interactions.

After presentation student will be aware of the key concepts related to medicinal product registration, will be able to present regulations and guidelines that are mandatory and very useful in an everyday work in regulatory affairs department. Presentation helps to understand the role of the Regulatory Affairs Department in the organization and shows the complexity of the interactions with external entities involved in medicinal product registration process. During the course student sees useful definitions and industry terms that are specific and unique for the medicinal product registration and pharmaceutical industry.

After this course you will get basic information about:

• General scheme of the registration process of the medicinal products
• Types of marketing authorization procedures
• Types of registration applications
• Regulations and guidelines useful in regulatory affairs specialists work
• Dossier and its structure
• Maintenance of the Dossier and what affects the dossier
• Types of changes (variations) that are available to be submitted
• Other teams in the organization that might be important for your work
• Variety of Regulatory Affairs Departments and their role