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REGULATORY AFFAIRS Biosciences Regulatory Affairs 19-unit minimum REGULATORY AFFAIRS CERTIFICATE Certificate Program Regulatory Affairs Certificate Contact Applied and Natural Sciences Department, (408) 861-3860 or e-mail program@ucsc-extension.edu. Program Overview Regulatory affairs professionals play critical roles in ensuring compliance with the laws and regulations guiding the development and commercialization of health care products. As Bay Area bioscience companies grow and mature, their need for trained regulatory personnel intensifies. Recent industry studies cite regulatory affairs as one of the most crucial human resource needs in the coming decade. However, there are currently few options available in our region for formal, in-depth training for early-stage regulatory professionals. The Regulatory Affairs Certificate was developed under the guidance of industry and government experts to provide a broad regulatory foundation; exposure to practical, real-world applications of the regulations; and an appreciation of the important roles that regulatory affairs professionals play in the bioscience industry. Courses are taught by experienced regulatory professionals currently working in the device, diagnostic, pharmaceutical and biologic sectors. Instructors bring the regulations to life with relevant examples and hands-on exercises designed to prepare students for rewarding careers in regulatory affairs. Certificate Requirements To obtain the Certificate in Regulatory Affairs, students must complete the seven required courses and 4 units of elective courses, for a minimum total of 19 units. For GPA requirements and program time limits, see page 4. To pursue two bioscience-related certificates in parallel or sequence, see page 7. Courses may be taken individually or as part of the certificate program. Prerequisites Given the scientific foundations of the bioscience industry and the importance of effective communication to the regulatory role, students who come to the program with a basic understanding of the life sciences and strong written and oral communication skills will benefit most from this program. Recommended Course Sequence We recommend students begin the program with “Drug Development Process” or “Regulation of Medical Devices and Diagnostics.” For More Information Current and future course schedules can be found at ucsc-extension.edu/biosciences. For more information or to be added to our mailing list, please call (408) 861-3860 or contact program@ucsc-extension.edu. For Certificate Application Information and Policy on Transferring Credit from Other Schools, see page 4. Required Courses (seven) units Course F W Sp Su Drug Development Process....................................................2.0...........6559 n n n n Regulation of Medical Devices and Diagnostics ...................3.0.........19071 n Regulation of Drugs and Biologics ........................................3.0.........19007 n n One of the following* Regulatory Submissions: Drugs and Biologics OR..................2.0.........19067 n n Regulatory Submissions: Devices and Diagnostics ................2.5.........19315 n n One of the following* Good Manufacturing Practices OR.........................................3.0...........6328 n n Regulatory Compliance for Medical Devices .........................2.5.........19029 n n Interacting with the FDA .......................................................1.5.........19318 n n RA Professional’s Toolbox .....................................................1.5.........19317 n n *The remaining submissions or compliance courses may be used as electives. Elective Courses (4 units required) Units Course F W Sp Su Regulatory Design Control for Product Development .............................2.0.........21973 n Drug Quality Fundamentals...................................................1.5.........23400 n Electronic Records for Regulated Environments: Cost-Effective Approaches to Compliance.........................1.5.........19362 n n Global Medical Device Submissions and Strategy.................1.5.........20343 n Human Factors in Medical Device Development....................2.0.........23097 n n Medical Writing......................................................................2.0...........4451 Post-Market Regulatory Obligations for Medical Devices......1.5.........22414 n Regulation of Biomedical Product Advertising, Promotion and Labeling......................................................................1.5.........20756 Regulatory Intelligence .........................................................1.0.........20341 n Risk Management for Regulated Industries ..........................3.0.........22631 n n Value-Added Quality Audits ..................................................1.5.........19073 n Clinical Adverse Event and Medication Coding: An Introduction to MedDRA, COSTART, and WHO-Drug....1.5.........19976 n Clinical Statistics for Non-Statisticians...................................2.0...........2345 n n Drug Safety and Adverse Events Reporting ...........................1.0...........3990 n n Electronic Data Capture for Clinical Trials..............................1.0.........20777 n Global Conduct of Clinical Trials ...........................................1.5.........20787 n n Good Clinical Practices..........................................................3.0...........0458 n n n Preparing for FDA Inspections and Conducting Sponsor Audits...................................................................1.5...........5168 n Science of Clinical Trials Design.............................................2.5...........3657 n n n Discovery/Development (A maximum of 1.5 units may be applied toward the elective requirement.) Intellectual Property Essentials for the Life Science Industry...1.0...........1942 n Medical Device Design and Development..............................2.0.........19977 n n Molecular Diagnostics............................................................1.5.........21972 n n Pharmacology, Principles.......................................................2.0...........5596 Product Development Life Cycle for Medical Devices............2.0.........23084 Toxicology Basics for Biotechnology......................................1.5...........2310 n n held in classroom m offered online p both classroom and online sessions are available RAPS Credit Many of the required and elective courses in UCSC Extension’s Clinical Trials and Regulatory Affairs Certificate Programs qualify for points toward recertification for RAC. See the Regulatory Affairs Professionals Society Web site at www.raps.org for details. Visit ucsc-extension.edu for the most current program schedule. 16 Enroll on our Web site with a credit card. It’s the fastest, easiest way to get started. Visit ucsc-extension.edu.
Biosciences REGULATORY AFFAIRS Required Courses Drug Development Process For course description, see page 9. Regulation of Medical Devices and Diagnostics NATSC.X400.017 (3.0 quarter units) Starting with the definition of medical devices, an overview of the medical device industry, and the historical roots of medical device regulation, the instructor lays a foundation for understanding the unique aspects of medical devices and the pathways through which various classes of products are moved into the U.S. marketplace. Students gain in-depth exposure to key routes to market, including 510(k) premarket notification and premarket approval applications (PMA). Students gain insight into the rationale and strategies for using each of these paths, as well as the clinical testing of devices, and the investigational device exemption (IDE) application and process. NANCY ISACC, J.D., M.S. ANNA LONGWELL, J.D., M.B.A., M.S. SANTA CLARA CLASSROOM WITH ONLINE MATERIALS 10 meetings: Wednesdays, 6–9 pm, March 28–June 20 (3 no meetings TBA). Fee: $825 ($82.50 discount for early enrollment). To enroll, use Section Number 19071.(013) Regulation of Drugs and Biologics NATSC.X400.009 (3.0 quarter units) Complex regulations govern the development, manufacture, and commercialization of biomedical products. This course helps participants understand the regulatory requirements, both U.S. and international, for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. Students gain knowledge and insight into the regulatory agencies and their roles and responsibilities; regulatory applications and pathways; postmarketing requirements; the impact of regulatory differences between the U.S. and other countries; and how regulatory approval processes affect corporate strategy. Prerequisite(s): Completion of, or concurrent enrollment in “Drug Development Process” or equivalent experience. SHELDON MULLINS, M.B.A. SANTA CLARA CLASSROOM 10 meetings: Mondays, 6–9 pm, April 9–June 25 (1 no meeting TBA). Fee: $825 ($82.50 discount for early enrollment). To enroll, use Section Number 19007.(014) Regulatory Submissions: Drugs and Biologics NATSC.X400.014 (2.0 quarter units) Submissions to a regulatory agency such as the FDA involve more than just writing. They also encompass strategy, editing, publishing and systematic tracking of key information. Through lectures, case studies and hands-on exercises, new and experienced regulatory professionals learn how to work with regulations, guidance documents and style guides to produce submissions that comply with the requirements and are clear to the reviewers. This practical course uses approved drug labels and summary basis of approvals to help students acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including premarketing (IND), marketing (NDA/CTD) and postmarketing documents. Students also gain experience with tools that help manage timelines and sections needed from contributors. Prerequisite(s): “Drug Development Process,” and “Regulation of Drugs and Biologics.” MEREDITH BROWN-TUTTLE, RAC. SANTA CLARA CLASSROOM 8 meetings: Tuesdays, 6–9 pm, April 10–June 26 (4 no meetings TBA). Fee: $860 ($86 discount for early enrollment). To enroll, use Section Number 19067.(012) Regulatory Compliance for Medical Devices NATSC.X400.012 (2.5 quarter units) Lectures, interactive discussions and case studies provide in-depth exposure to the fundamental concepts and major issues central to regulatory compliance in the medical device sector. Emphasis is placed on using the principles in the medical device quality system (QS) regulation and ISO 13485 as tools to take a process-oriented, risk-based approach to compliance, while achieving strategic business objectives in today’s dynamic regulatory environment. Students learn about key quality system regulation processes and how to recognize noncompliance. The instructor provides insight into implementing an effective CAPA system and using it as an improvement tool. Current industry trends, FDA initiatives and best practices when interacting with regulatory agencies are also discussed. KIRAN GULATI, M.B.A., RAB-LA. SANTA CLARA CLASSROOM 7 meetings: Wednesdays, 6–9:30 pm, April 4–May 23 (1 no meeting TBA). Fee: $800 ($80 discount for early enrollment). To enroll, use Section Number 19029.(013) RA Professional’s Toolbox NATSC.X400.025 (1.5 quarter units) This seminar-format course addresses important competencies for RA professionals, including negotiation and communication strategies, effective collaboration techniques, project management, and approaches to educating and motivating senior management and staff about compliance. Through discussions, real-world examples and case studies, senior regulatory professionals help students learn about regulatory strategy, how to work in the regulatory “gray zones,” and the important legal and ethical responsibilities of regulatory affairs personnel. This course should be taken toward the end of the Regulatory Affairs Certificate Program curriculum. LAURENCE WALLMAN, M.A., RAC (US, EU, CAN). SANTA CLARA CLASSROOM WITH ONLINE MATERIALS 5 meetings: Thursdays, 6–9 pm, May 17–June 28 (2 no meetings TBA). Fee: $700 ($70 discount for early enrollment). To enroll, use Section Number 19317.(010) Regulatory Affairs Advisory Board Eric Anderson, Supervisory Investigator, Food and Drug Administration Meredith Brown-Tuttle, RAC, Consultant, Regulatory Affairs Jonathan Harris, Regulatory Affairs, Genentech David Hoffmeister, Esq., Partner, Life Sciences Practice, Wilson Sonsini Goodrich & Rosati Anna M. Longwell, Esq., President, Anna Longwell, PC Jane Moffitt, J.D., LL.M., RAC, Director, West Coast Operations, SciLucent Kathy Nusser, CQA, RAC, Corporate Regulatory Affairs Manager, Varian Medical Systems, Inc. Virginia Perry, RAC, CQE, Partner, Regulatory Affairs/Medical Devices, Perry-D’Amico & Associates Michelle Roeding, RAC, Section Manager, Regulatory Affairs, Abbott Diagnostics Division— Santa Clara Robert I. Roth, M.D., Ph.D., Medical Director, The Weinberg Group Inc. ACCESS TO ONLINE MATERIALS online materials indicates that classroom instruction is supplemented with online materials or activities. Students who enroll in these courses, and in those which are entirely online, will receive logon information within 24 hours. However, valid logon information may not be active until the course’s start date. Course Readers, Textbooks and Other Instructional Resources Students are responsible for obtaining the required instructional materials for all courses. A variety of media are used. Please review the section details at the bottom of the course description pages on our Web site. Instructors may specify any of the following: • Printed course readers from our on-demand service provider, Content Management Corporation (CMC) • Electronic course materials from our online learning platform, UCSC Extension Online • Textbooks (required and recommended). See pages 5 and 94 and visit ucsc-extension.edu/bookstore. • Other materials distributed via e-mail either by the Academic Department or the instructor Students should acquire or access their materials prior to the first class meeting. For full instructions, go to ucsc-extension.edu/course-materials. Copyright © 2012 The Regents of the University of California. All Rights Reserved. 17
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