CERTIFICATION COURSE IN BIOLOGICS AND BIOSIMILAR

LIST OF THE TOPICS

✔Introduction to biopharmaceuticals

✔Biopharmaceutical Classification

✔Chemical Drugs vs Biological Drugs

✔Principle of naming of biologic

✔Global biologics market

✔Recombinant proteins

✔Monoclonal vs polyclonal antibodies

✔Monoclonal antibodies Mfg.

✔Biological license application

✔Abbreviated biosimilar application

✔Purple book

✔Vaccine development and approval process

✔Biosimilar development process

✔Strategic development of biosimilar

✔Biomanufacturing process

✔Studies required for approval of biosimilar

✔Regulatory requirements for biologics and biosimilar

✔Comparability of biosimilar

✔CQA and CPP for biopharmaceuticals

✅CERTIFICATE: Receive a certificate upon successfully finishing this course

✅COURSE DURATION: 493 Minutes (8.2 Hours)

✅LANGUAGE: English

✅SELF PACED LEARNING: Offered as an online course featuring pre-recorded videos and structured for distance learning, this program is available to participants globally.

✅LIFETIME ACCESS: You will have lifetime access to the course