Bioscience Industry Teams with Colorado State University to Create Online Regulatory and Clinical Trial Management Certificate Programs

Colorado State University has joined with numerous bioscience industry partners on a new educational collaboration that includes the creation of online regulatory affairs courses and clinical trial management courses for the pharmaceutical, medical device, in-vitro diagnostic, and tissue industries.

Companies and organizations involved in the Regulatory Affairs Industry/Academic Consortium partnership through CSU’s School of Biomedical Engineering include Medtronic Navigation Inc., Allosource, Baxa Corp., the U. S. Department of Agriculture/National Wildlife Research Center, Reglera, CPC Clinical Research, Regulus Pharmaceutical Consulting, Polsinelli & Shugart PC, the Medical Center of the Rockies Foundation and the Colorado Bioscience Association.

The courses are designed to meet regulatory requirements of the federal government.

“This collaboration brings together leaders in academia and industry to more rapidly advance critical training for individuals working in pharmaceutical, biotech and medical device companies,” said Stu Tobet, director of the School of Biomedical Engineering (SBME). “This collaboration exemplifies SBME’s and Colorado State University’s commitment to creatively partner with industry in ways that will help promote transformational science and technology. It also advances our mandate of serving the public interest and preparing the bioscience workforce by making our educational institution available to Colorado’s growing bioscience economy.”

"With our world headquarters here in Colorado, we welcome this education offering as it will provide us access to a broader base of regulatory affairs expertise," said Jim Cloar, vice president and general manager for GM Medtronic Navigation Inc. "We believe this program will become an asset for all the local medical device and bioscience companies."

Clay Anselmo, president and CEO of Reglera, one of the largest and fastest growing regulatory consulting and outsourcing companies in the world, has said, “These courses will give the participants a better understanding of what needs to be done with regard to navigating the regulatory maze that surrounds the biomedical industry.

"Regulatory and quality expertise is an absolute necessity in the fast-paced biomedical marketplace, and this is real-world medical device knowledge that will be immediately useful in future daily activities," Anselmo said. "With an increased emphasis on training and validation from the FDA, these courses will enable the participants to get vital medical devices to their customers with all the correct procedures in place.”

All funding and revenue generated through the courses and consortium will be funneled back into the program for expansion, scholarships and annual “best practices” roundtable meetings in collaboration with the Colorado Bioscience Association and the Denver District Food and Drug Administration.

For their commitment to education, consortium members will be provided with discounted course tuition for their employees.

“Colorado’s bioscience industry is lucky to have such a remarkable program in its backyard, meeting the increasing demand of regulatory needs of its local companies and providing an incredible resource for the region. This program adds to the value of growing a bioscience company in Colorado, and we are proud to be a partner in the effort,” said Holli Baumunk, president and CEO of the Colorado Bioscience Association.

Recently announced new course offerings in the School of Biomedical Engineering include an online Master of Engineering Degree specializing in biomedical engineering and a dual bachelor’s degree. The five-year dual degree program provides the depth of a traditional engineering major (electrical, mechanical or chemical and biological engineering) with the breadth of a biomedical engineering degree. These new degree programs complement the existing first-in-the-state master’s and doctoral degrees already offered in Biomedical Engineering.

By partnering with the local medical device, biotechnology and pharmaceutical industries to address unmet educational needs, the School of Biomedical Engineering will open the door for future research collaborations between industry and academia. Colorado companies, like other global companies, face competition from generic pharmaceutical manufacturers. The Colorado State University Regulatory Affairs consortium provides one venue to help boost the state’s economy by assisting local industry.

“In the long term, enhancing academic/industry relations will help translate basic science findings to useful technology that will refill product pipelines,” Tobet said.

For more information about courses or the Consortium, go to or contact Deanna Scott, Director of the Regulatory Affairs Interdisciplinary Programs at (970) 402-5330 or