Foundational knowledge and regulatory framework governing biologics, including monoclonal antibodies, vaccines, cell and gene therapies. Participants will gain a solid understanding of regulatory requirements, submission processes, and compliance considerations to support biologics development, commercialization of the products and life-cycle management including product stewardship.
Athena Title
Biopharmaceuticals
Non-Traditional Format
This course will be taught 95% or more online.
Prerequisite
PHAR 6010 or PHAR 6010E or permission of department
Semester Course Offered
Offered spring
Grading System
A - F (Traditional)
Student learning Outcomes
Students will understand unique characteristics and challenges of biologics including monoclonal antibodies, vaccines, oligonucleotides, cell and gene therapy products.
Students will be able to describe regulatory framework and submission requirements.
Students will develop strategies for successful clinical trial applications and marketing approvals.
Students will be able to explain post-market compliance, Pharmacovigilance and risk management requirements.
Students will be knowledgeable in emerging trends such as advanced therapies including cell and gene therapies and vaccine.
Students will be able to strategize, prepare and respond to regulatory authority questions (applications, submissions and inspections).
Topical Outline
Introduction to biologics
Regulatory framework
Clinical trial design and special considerations
Chemistry, manufacturing and controls (CMC) for biologics
Market application submissions
Cell and gene therapies
Vaccines
Monoclonal antibodies and oligonucleotides
Advisory committee meetings
Pharmacovigilance, risk management, REMS, real world evidence and post marketing commitments
