Program Overview

Introduction to the Biologics and Biosimilars: Regulatory Aspects Certificate Program

The Biologics and Biosimilars: Regulatory Aspects Certificate Program is designed to explore the regulatory issues unique to biologics and biosimilar drug manufacturers. This program delves into the challenges in the path to global commercialization of a biological product, including an overview of current regulatory and technical issues involved in developing biological products in major ICH regions.

Program Overview

The program consists of five courses and builds a strong foundation in the biologics and biosimilar regulatory landscape. It exposes students to key trends and controversies facing the biologics and biosimilar industry, enabling them to become fluent in the methods used in the discovery of biopharmaceutical products.

Course Requirements

Students must complete three required courses:

• Drug Development (RAQA 5459)
• Biologics/Biosimilars: A Regulatory Overview (RAQA 5515)
• Global CMCs Biopharmaceuticals and Other Biologics (RAQA 5577) And choose two electives from:
  • Production of Sterile Products (RAQA 5492)
  • Regulatory eSubmissions (RAQA 5514)
  • Clinical Drug Safety and Pharmacovigilance (RAQA 5538) OR RAQA 5571)
  • Special Topics in RAQA - Current Trends in Clinical Trials (RAQA 5560)
  • Post-Marketing Safety Surveillance (RAQA 5571) OR RAQA 5538
  • Vaccines: RA and QA Issues (RAQA 5572)

Admission Requirements

To be eligible for the program, applicants must have:

• A baccalaureate degree with an undergraduate GPA of 3.0 or higher
• Transcripts from all post-secondary institutions attended
• Applicants who earned a degree at a non-U.S. institution must submit an equivalency evaluation of their transcript(s) through a third-party provider
• A current resume or CV
• A statement of goals (approximately 500 to 1,000 words) stating their specific interest in the program, research goals, future career goals, and academic and research achievements
• Standardized test scores for applicants who earned their baccalaureate degree from an institution where the language of instruction was other than English

Program Details

All courses may be completed online. The GRE is not required for the Biologics and Biosimilars: Regulatory Aspects Certificate. Students may obtain only one certificate before completing the MS program, except for Food RA and QA.