a.	Understand the requirements for the submission of quality/chemistry, manufacturing, and controls section on the common technical document. Be able to prepare Module 2 Quality Overall Summary and Module 3 Quality dossier. 
b.	Support development project teams by delineating the regulatory requirements as outlined in the ICH guidelines and pharmacopeias in developing a quality product. 
c.	Discuss the requirements for an IND and BLA/NDA submission versus submission to health authorities such as the EU, Latin America, and Japan. 
d.	Prepare the generic application (question-based review) for submission to FDA.
e.	Define the role of knowledge management and change control to manage post-approval changes for drugs and biologics to maintain compliance with regulations. 
f.	Strategize, prepare, and respond to regulatory authority questions (applications, submissions) and inspections.

The course will cover the life cycle and knowledge management of drug products and biologics from the discovery of the chemical entity or moiety through development into a medicinal product and commercialization and maintaining the product in the market. Most drug products and biologics are developed for marketing globally, and the course will cover CMC or quality module requirements for submission to health authorities for marketing authorization and post-approval commitment submissions required for maintaining the products in the marketplace. The course will also focus on how to write the CMC and quality module for submissions and how to respond to health authority questions.

All academic work must meet the standards contained in A Culture of Honesty. Each student is responsible to inform themselves about those standards before performing any academic work. A Culture of Honesty is the University of Georgia's policy and procedures for handling cases of suspected dishonesty and can be found online at www.uga.edu/ovpi. UGA Student Honor Code states "I will be academically honest in all of my academic work and will not tolerate academic dishonesty of others."