Would you like to know what is and what are the objectives of Company Core Safety Information (CCSI)? If so, please join this course. The objective of this course is to perform introduction training to Company Core Safety Information and Product Information Update based on updated knowledge about product safety profile.
What is CCSI? All relevant safety information contained in the company core data sheet prepared by the marketing authorisation holder and which the marketing authorisation holder requires to be listed in all countries where the company markets the product, except when the local regulatory authority specifically requires a modification. It is the reference information by which listed and unlisted are determined for the purpose of periodic reporting for marketed products, but not by which expected and unexpected are determined for expedited reporting.
Would you like to know more? Join the course!
After course completion, student:
- Demonstrates knowledge and understanding of key CCSI concepts, principles, methods and tools
- Demonstrates knowledge of key CCSI regulations and guidelines (including guidelines of CIOMS III and V working groups)
- Can explain the roles and responsibilities of the various entities involved in the preparation, submission, maintenance, update and evaluation of CCSI
- Has a basic theoretical knowledge of CCSI
- Can explain the purpose and structure of CCSI / CCDS
- Can design and discuss the development process of the first CCSI / CCDS
- Can design and discuss the CCSI / CCDS update process (what, when and how)
- Can compare the process of preparing, maintaining and updating CCSI / CCDS for an innovative product and a generic product
- Is able to manage the topic of national differences in medicinal product information
