Based on the EMA Annual Report from 2021, variations are definitely the most common regulatory procedure from the post authorization stage of the products lifecycle. Therefore, this course will provide you with a solid background for variation management. You will dive into the variation classification, such as variations type IA, IB and II variation categories, such as administrative, quality or safety and documentation required to be enclosed to the variation package. Each variation type is presented in more details, covering procedural timelines, principles on assessment phase and approval and/or rejection. Moreover, you will learn more about notifications, some aspects related to variation management such as best practice and importance of communication between main stakeholders.

The student after completing this course should be able to:

• Demonstrate knowledge about key regulations and guidance in terms of variations and understanding on variation definition and list possible reasons for variations
• For variations type IA/IB (foreseen and unforeseen)/II: demonstrate understanding of basic theory and have fundamental practice skills in terms of variations understand key terms, rules, and tools (variation classification / submission timelines / validation, assessment phase, approval/rejection, receiving decision / implementation date / reasons of rejection)
• List the main and supportive documentation required for variation submission
• Classify variation in terms of specific category: administrative, quality, safety and explain main principles of CEP procedure
• Explain and describe Notification Art. 61(3) procedure for medicinal product
• Manage the preparation stage of variation submission by regulatory professional
• List and explain roles and duties of various stakeholders in variation management