By

Michael Bartlett

by Mickey Y. Montevideo, Prajakta Dhapte

The University of Georgia College of Pharmacy has launched the Institute for International Biomedical Regulatory Sciences.

The first-of-its kind institute will address the increased challenges and opportunities in regulatory sciences caused by advances in technology and sciences in the biomedical field.

The institute will focus on collaborative partnerships, integrative research, education, training and outreach to meet its primary objective, which is the safe implementation of various biomedical products, including pharmaceuticals, vaccines, medical devices, biologics, animal health products and combination products.

“Regulatory sciences provide the framework needed to ensure that constant, exciting new discoveries from biomedical scientists will be safely translated into effective treatments,” said Michael Bartlett, founding director of the new institute and associate dean for science education, research and technology at the College of Pharmacy. “This institute will be a perfect amalgamation between industry, government and academia, and will offer valuable opportunities to students, researchers and professionals in this important field.”

Focusing on workforce development, the institute will offer educational programs through graduate certificates, Master of Science degree programs, conferences and workshops. Graduate level courses will be web-based. The institute’s partnerships across various departments of UGA will allow students from other full-time degree programs to enroll in classes offered.

Partnering with the U.S. Food and Drug Administration, the institute will sponsor two conferences per year. The International Good Manufacturing Practices Conference and the Medical Device Regulations Conference will take place at the main UGA campus in Athens and the UGA Gwinnett campus in Lawrenceville respectively. Both conferences will offer academic and continuing education credits as well as networking opportunities for attendees.

Participating faculty members come from across campus including the College of Pharmacy, College of Public Health, College of Veterinary Medicine, Franklin College of Arts and Sciences, and the College of Engineering. The group offers a wide range of expertise; some of the major research areas include the development of novel and improved biopharmaceutics and biocompatible materials, quality control, quality assurance and security of biomedical products.

“The creation of any new biomedical therapy occurs on a global scale,” said Bartlett. “The regulatory scientist must not only support the filing of these new therapies with the myriad of regulatory agencies across the world but also needs to understand the complex manufacturing process and supply chain that underlies any product. The regulatory scientist is involved in all of these activities and plays a vital role in ensuring the safety of the products that are used by providers and consumers.”

For further information, see the institute’s website at www.gaiibrs.uga.edu.