[February 14, 2012]

UC Irvine Extension Spring Regulatory Affairs Courses Pre-Approved by Regulatory Affairs Professionals Society

The University of California, Irvine Extension announces that its spring Regulatory Affairs Program courses have been pre-approved by the Regulatory Affairs Professionals Society (RAPS), which allows participants to be eligible for up to 12-16 credits from UC Irvine Extension towards a Regulatory Affairs Certification (RAC), a professional distinction that denotes a commitment to excellence, pursuit of knowledge and career advancement. This certification is provided by the Regulatory Affairs Professionals Society (RAPS), a leading international organization of regulatory professionals that work to ensure the safety, effectiveness and availability of healthcare products that include medical devices, pharmaceuticals and biotechnology.

"UC Irvine Extension's regulatory affairs courses increase our students' value to their employers, and we support RAPS' commitment to advancing the careers of those in the healthcare products profession," said Dave Dimas, director of engineering, sciences and information technology at UC Irvine Extension. "Students who enroll in our courses to achieve RAC certification will have the opportunity to advance more quickly in the healthcare products field, and will have the potential for increased compensation."

Pre-approved certified regulatory course offerings include:

• Regulatory Requirements for Medical Devices
• Regulatory Requirements for Pharmaceutical Products
• Regulatory Affairs Planning and Management Concept Review and Evaluation
• Regulatory Affairs for Post Market Approval
• Biomedical Business and Legal Management Essentials

Courses offered this spring include:

• Regulatory Affairs for Post-Market Approval - This online course will teach participants about "design transfer" from research and development to manufacturing, along with strategies of how to manage regulatory affairs activities for design modifications, post approval studies and after market product change. The 12 credit course will run from April 9 - May 20, 2012.
• Regulatory Requirements for Pharmaceutical Products - This online course presents a detailed overview of the regulatory requirements for the development and manufacture of pharmaceutical products for participants. Attendees will learn about the product development process through commercialization, product characterization and pre-clinical evaluation, clinical trial requirements, along with additional topics. The 16 credit course will run from March 26 - June 10, 2012.

• Regulatory Requirements for Medical Devices - Online course participants will be provided with an understanding of the essential U.S. medical device regulations, including device classification, organizing pre-market notification 510(k), and planning and submitting a pre-market approval (PMA). Attendees will increase their knowledge of topics that include: global vigilance requirements and labeling requirements, European Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. The 16 credit course will run from March 26 - June 10, 2012.

About UC Irvine Extension: University of California, Irvine Extension is the continuing education arm of UC Irvine. Through thousands of courses and programs offered on campus, online and on site, UC Irvine Extension helps adult learners reach their career advancement and personal enrichment goals - and is celebrating 50 years of providing universally accessible, university-level learning to local, regional, and global communities. Learn more at extension.uci.edu, or join us on Facebook (News - Alert) at facebook.com/uciextension.

About the University of California, Irvine: Founded in 1965, UCI is a top-ranked university dedicated to research, scholarship and community service. Led by Chancellor Michael Drake since 2005, UCI is among the most dynamic campuses in the University of California system, with nearly 28,000 undergraduate and graduate students, 1,100 faculty and 9,000 staff. Orange (News - Alert) County's largest employer, UCI contributes an annual economic impact of $4.2 billion. For more UCI news, visit www.today.uci.edu.

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