About
💻𝗖𝗢𝗨𝗥𝗦𝗘 𝗦𝗨𝗠𝗠𝗔𝗥𝗬: This online course, "Certification Course in Biologics and Biosimilar Regulations," offers an in-depth exploration of the biopharmaceutical industry, focusing on the development, approval, and regulation of biologics and biosimilars. Starting with foundational knowledge about biopharmaceuticals and their classification, the course covers key topics such as the differences between chemical and biological drugs, naming conventions, and the global market landscape. Detailed modules discuss the production and regulation of monoclonal antibodies, the specifics of biological license applications, and the pathway for biosimilar development including strategic, manufacturing, and regulatory aspects. Additionally, the course examines the CQAs and CPPs essential for biopharmaceutical production. 💻𝗟𝗜𝗦𝗧 𝗢𝗙 𝗧𝗛𝗘 𝗟𝗘𝗖𝗧𝗨𝗥𝗘𝗦: 1. Introduction to biopharmaceuticals 2. Biopharmaceutical Classification 3. Chemical Drugs vs Biological Drugs 4. Principle of naming of biologic 5. Global biologics market 6. Recombinant proteins 7. Monoclonal antibodies vs polyclonal antibodies 8. Monoclonal antibodies 9. Biological license application 10. Abbreviated biosimilar application 11. Purple book 12. Vaccine development and approval process 13. Biosimilar development process 14. Strategic development of biosimilar 15. Biomanufacturing process 16. Studies required for approval of biosimilar 17. Regulatory requirements for biologics and biosimilar 18. Comparability of biosimilar 19. CQA and CPP for biopharmaceuticals 𝗖𝗘𝗥𝗧𝗜𝗙𝗜𝗖𝗔𝗧𝗘: 🎓Receive a certificate upon successfully finishing this course 𝗖𝗢𝗨𝗥𝗦𝗘 𝗗𝗨𝗥𝗔𝗧𝗜𝗢𝗡: ⏳488 Minutes (8.13 Hours) 𝗟𝗔𝗡𝗚𝗨𝗔𝗚𝗘: 📖English 𝗦𝗘𝗟𝗙 𝗣𝗔𝗖𝗘𝗗 𝗟𝗘𝗔𝗥𝗡𝗜𝗡𝗚: 🌏 This program is available to participants globally. ⚡𝗗𝗢𝗪𝗡𝗢𝗟𝗗𝗔𝗕𝗟𝗘 𝗥𝗘𝗦𝗢𝗨𝗥𝗖𝗘𝗦: Participant can download all presentations/Reports 𝗔𝗖𝗖𝗘𝗦𝗦: 🎧You will have 6 month (180days) access to the course
You can also join this program via the mobile app. Go to the app