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CERTIFICATION COURSE IN BIOLOGICS AND BIOSIMILAR REGULATIONS

  • 3650Days
  • 19Steps
Get a certificate by completing the program.

About

๐Ÿ’ป๐—–๐—ข๐—จ๐—ฅ๐—ฆ๐—˜ ๐—ฆ๐—จ๐— ๐— ๐—”๐—ฅ๐—ฌ: 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. ๐Ÿ’ป๐—Ÿ๐—œ๐—ฆ๐—ง ๐—ข๐—™ ๐—ง๐—›๐—˜ ๐—Ÿ๐—˜๐—–๐—ง๐—จ๐—ฅ๐—˜๐—ฆ: 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 ๐—–๐—˜๐—ฅ๐—ง๐—œ๐—™๐—œ๐—–๐—”๐—ง๐—˜: ๐ŸŽ“Receive a certificate upon successfully finishing this course ๐—–๐—ข๐—จ๐—ฅ๐—ฆ๐—˜ ๐——๐—จ๐—ฅ๐—”๐—ง๐—œ๐—ข๐—ก: โณ488 Minutes (8.13 Hours) ๐—Ÿ๐—”๐—ก๐—š๐—จ๐—”๐—š๐—˜: ๐Ÿ“–English ๐—ฆ๐—˜๐—Ÿ๐—™ ๐—ฃ๐—”๐—–๐—˜๐—— ๐—Ÿ๐—˜๐—”๐—ฅ๐—ก๐—œ๐—ก๐—š: ๐ŸŒ This program is available to participants globally. โšก๐——๐—ข๐—ช๐—ก๐—ข๐—Ÿ๐——๐—”๐—•๐—Ÿ๐—˜ ๐—ฅ๐—˜๐—ฆ๐—ข๐—จ๐—ฅ๐—–๐—˜๐—ฆ: Participant can download all presentations/Reports ๐—”๐—–๐—–๐—˜๐—ฆ๐—ฆ: ๐ŸŽงYou will have 6 month (180days) access to the course

You can also join this program via the mobile app.

Instructors

Price

Single Payment
โ‚น4,999.00
BIOLOGICS & BIOSIMILAR REGULATIONS
โ‚น2,900.00

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