1 witer Jauary March 2014 ONLINE AND IN SANTA CLARA COURSES START WEEKLY UCSC-EXTENSION.EDU Egieerig & Techology BioScieces Educatio Busiess & Maagemet
2 ew courses Ifo Sessios ENGINEERING AND TECHNOLOGY Adobe Photoshop, Itermediate Desigig System Power Maagemet for Zero Power Mobile Sesig ad Huma Iterface Techologies C++ 11 Stadard Programmig: Advaced Topics ad Gamig Project 3REVISED SystemVerilog Assertios ad Formal Verificatio USB Device Programmig PROFESSIONAL AWARD Mobile Applicatio Developmet BUSINESS AND MANAGEMENT Busiess to Busiess (B2B) Marketig Commuicatios: Leveragig Emergig Social Media Techologies Cross-Cultural Negotiatio: Asia ad Wester Busiess Eviromets PROFESSIONAL AWARD Busiess Aalysis UCSC O-site Master s Degrees ENGINEERING & TECHNOLOGY Master of Sciece Degree i Electrical Egieerig Professioal Master of Sciece Degree i Techology ad Iformatio Maagemet Master of Sciece Degree i Games ad Playable Media EDUCATION Master of Arts Degree i Educatio ad Teachig Credetial i Secodary Sciece Lear about our programs, etwork with workig professioals ad gai valuable isight from experts i your field of iterest. These coveiet eveig Iformatio Sessios are free ad offer a chace to explore our Sata Clara facility. Istructors, coordiators, ad program staff will outlie the specifics of courses, certificates, prerequisites ad the practical resources you ll eed to advace your career. Evets are free, but registratio is required. Sig up ow at ucsc-extesio.edu/evets. MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY ENGINEERING & TECHNOLOGY EDUCATION Jauary 2014 You re Ivited BIOSCIENCES Biotechology ad Bioiformatics 6 8:30 pm Web ad Iteractive Media Desig 6:30 8:30 pm Project ad Program Maagemet ad Advaced Applied Project Maagemet 6:30 8:30 pm Early Childhood Educatio Educatioal Therapy Istructioal Desig for Educators ad Corporate Traiers TESOL 6 8 pm Huma Resource Maagemet 6:30 8:30 pm olie oly Techical Writig ad Commuicatio Jauary 20 March 15* Accoutig ad CPA Busiess Admiistratio ad M.B.A. Prerequisites Marketig Maagemet Embedded Systems ad VLSI Egieerig 6:30 8:30 pm Cliical Trials, Regulatory Affairs, ad Medical Devices 6 8:30 pm Fiacial Plaig ad Wealth Maagemet Software Developmet 6:30 8:30 pm Iformatio Techology, Database ad Data Aalytics 6:30 8:30 pm Admiistrative ad Executive Assistats 6:30 8:30 pm BUSINESS & MANAGEMENT Ad programs *Erollmet accepted through March 4.
3 The Right Place to Expad Your Network C ould a ew coectio help you make big progress i your career? If you re readig this catalog, it s virtually certai that you re motivated ad forward-thikig, ready to lear ew skills ad tackle ew challeges. Now imagie hudreds of like-mided professioals, all uder oe roof, ispirig each other ad helpig each other lear. That s what Extesio does for thousads of studets every year. Dea Lyda M. Rogers, Ed.D. UCSC Extesio Silico Valley 2505 Augustie Drive Sata Clara, CA Volume 46 Number 4 November 2013 UCSC Extesio Silico Valley (USPS ) is published four times a year (February, May, July ad November) by UCSC Extesio Silico Valley, 2505 Augustie Drive, Sata Clara, CA Periodicals postage paid at Sata Clara, CA, ad additioal mailig offices, set free to those who request iformatio about UCSC Extesio Silico Valley activities. Postmaster: Sed address chage to: UCSC Extesio Marketig Departmet 2505 Augustie Drive Sata Clara, CA Desiged ad produced by UCSC Extesio s Marketig Departmet Copyright 2014 The Regets of the Uiversity of Califoria All Rights Reserved. New Address? To cotiue receivig the course catalog, sed both your old ad ew addresses ad zip codes to UCSC Extesio Silico Valley 2505 Augustie Drive Sata Clara, CA If possible, iclude the label from the back cover of this catalog. If you have received more tha oe copy of this publicatio, please pass it alog to a fried or colleague. Prited o 40% Post Cosumer Waste Newsprit, usig soy ad vegetable based iks. Our priter is certified by the Moterey Bay Area Gree Busiess Program. Please recycle. Not prited or mailed at state expese (11/1/13) IMPORTANT PHONE NUMBERS Registratio, Erollmet, Trascript ad Literature Requests, Studet Questios: (408) Erollmet Fax: (408) academic Departmets ad Uits Academic Services: (408) Corporate Traiig: (408) They build powerful ew skills, but they also make coectios that ca ulock pivotal opportuities. It s oe reaso why we host a growig umber of evets that help our studets build etworks ad cultivate success. Last fall, we hosted the first i a series of Networkig Socials, where studets from every disciplie gathered to meet, exchage ideas ad see others accomplishmets i a fu ad casual settig. Our guests exchaged cotact ifo ad leared which courses ad programs other Extesio studets have foud most valuable. At evets like these, we liste closely to studets. They provide isight that helps us tailor our programs to the realities of the job market. Feedback from professioals like you provided the impetus for two ew programs itroduced i this catalog. The Professioal Awards i Mobile App Developmet ad Busiess Aalysis are great optios for studets who wat to take a few courses ad quickly develop marketable skills i a growig field. Olie social etworkig has become a eormously valuable resource, but there s still somethig special about makig that face to face coectio. To fid out about the ext special evet, visit ucsc-extesio.edu/evets. You ll fid iformatio about upcomig forums, mixers, guest speakers ad more. I additio to special evets, thousads of ambitious professioals atted our quarterly Ifo Sessios. If you re iterested i gettig the big picture about a program or certificate, just flip to the iside cover of this catalog to fid the evet that s right for you. We look forward to seeig you soo! Sicerely, Lyda M. Rogers, Ed.D. Dea of UCSC Extesio Admiistrative Departmets Dea s Office: (408) Media Iquiries: (408) To make chages or correctios to the mailig label, call (408) Follow us o Facebook ad Twitter
4 Areas of Study Missio Statemet UCSC Extesio SILICON VALLEY combies the academic excellece of the Uiversity of Califoria with the expertise of seasoed practitioers to provide advaced professioal traiig that addresses the real-world eeds of people who work ad live i Silico Valley. Catalog Resources at a Glace New to UCSC Extesio? Start Here... 5 UCSC EXTENSION ONLINE Geeral Iformatio Erollmet Withdrawals ad Drops Taxpayer Relief Act Academic Policies Grades Trascripts Disabled Studet Services Grievace Resolutio Process Textbooks Ope campus/ cocurret erollmet Busiess ad Coferece Services Proctorig Services Istructor Biographies Idex Course Titles, Programs ad Evets Maps ad Directios scout (UC ONLINE ACADEMY)
5 Bioscieces...8 Bioscieces Bioiformatics...9 Biotechology...11 Cliical Trials Desig ad Maagemet...14 Medical Devices...18 Regulatory Affairs...19 Busiess ad Maagemet...21 Accoutig Accoutig...23 CPA Preparatio...25 Admiistrative ad Executive Assistat...25 Bookkeepig Certified Bookkeeper Program...27 Busiess Admiistratio Busiess Admiistratio...27 Graduate School Preparatio...29 Executive Educatio Silico Valley Busiess Leadership...29 Fiacial Plaig Persoal Fiacial Plaig...30 Huma Resources Huma Resource Maagemet...32 Strategic Huma Resources...35 Istructioal Desig for Educators ad Corporate Traiers...35 Legal Studies Paralegal Core...36 Paralegal Advaced...36 Marketig Marketig Maagemet...36 MCLE Credit...38 Project Maagemet Project ad Program Maagemet (PPM)...85 Busiess Aalysis...87 Advaced Applied Project Maagemet (AAPM)...89 Techical Writig ad Commuicatio...39 Web Cotet Maagemet...40 witer 2014 Educatio...41 Credetial Courses...42 Early Childhood Educatio Early Childhood Educatio...43 Early Childhood Educatio: Supervisio ad Admiistratio...45 Educatioal Therapy Educatioal Therapy...46 Istructioal Desig for Educators ad Corporate Traiers...47 Teachig Eglish to Speakers of Other Laguages (TESOL)...49 Master of Arts Degree i Educatio/ Teachig Credetial i Secodary Sciece Egieerig ad Techology...52 Hardware Systems ad VLSI Egieerig Embedded Systems...53 VLSI Egieerig...57 Iformatio Techology...59 Liux Programmig ad Admiistratio...61 Software Developmet Computer Programmig...64 Iteret Programmig ad Developmet...68 Mobile Applicatio Developmet...69 Software Egieerig ad Quality...70 Database ad Data Aalytics...72 Web ad Iteractive Media Desig...75 Master of Sciece Degree i Techology ad Iformatio Maagemet...78 Evirometal Health ad Safety...80 Hazardous Materials Maagemet...81 Occupatioal Safety ad Health Maagemet...81 Evirometal Safety ad Health Maagemet...81 HAZWOPER...83 Project Maagemet...84 Project ad Program Maagemet (PPM)...85 Busiess Aalysis...87 Advaced Applied Project Maagemet (AAPM)...89 UCSC Extesio Olie...90 Ope Campus Bioscieces Busiess ad Maagemet Educatio Egieerig ad Techology Evirometal Health ad Safety Project Maagemet UCSC Extesio Olie, Ope Campus, Geeral Ifo, Istructor Bios, Idex, Maps, Erollmet Form
6 Certificate Programs witer 2014 The Value of a UC Certificate UCSC Extesio Silico Valley offers certificate programs i a wide rage of subject areas. Developed with guidace from key idustry leaders ad academic experts, these programs preset Uiversity of Califoria-approved curricula that address the specific requiremets of the disciplie. Programs take a practical approach, ad are structured to accommodate workig professioals. Most certificates cosist of required courses ad a specified miimum um ber of elective courses/uits, through which a program ca be tailored to meet a idividual s educatioal ad career goals. For more iformatio about specific certificate programs, please refer to the page umbers listed i the adjacet colum. Certificate Program Requiremets I order to be eligible for a certificate, you must: complete all course work withi three years of filig the applicatio receive a passig letter grade i all courses; ad achieve a overall 3.0 grade-poit average (GPA) for all courses applicable to the certificate. Please refer to www2.ucsc.edu/gpacalc for our GPA calculator. All courses applied to the certificate must have bee successfully completed withi five years of the date of certificate issuace. Requiremets for idividual programs may vary slightly. Please cosult specific program descriptios for additioal iformatio. Applyig for a Certificate We ecourage you to establish cadidacy i a certificate program early i your studies. This esures that curriculum chages subsequet to receipt of your applicatio will ot affect your course requiremets. Cadidates will be otified of updates or special opportuities related to their program. Certificate applicatios ca be submitted olie at ucsc-extesio.edu. To complete your certificate, you ll eed to eroll i the Certificate review course ad pay a $75 fee. Oce paid, please cotact to request the issuace of your certificate. Certificate with Hoors Those studets who complete a certificate program with a grade-poit average of 4.0 will ear a Certificate with Hoors. Trasferrig Courses from Other Schools Subject to the approval of the relevat UCSC Extesio academic departmet, studets may substitute oe equivalet course from aother istitutio for oe i a applicable certificate program. The course must have bee take withi the past five years with a grade of C or better, cover the same material as our equivalet course, carry the same or more credit, ad origiate from a accredited academic istitutio. Please cosult specific program descriptios for additioal iformatio, as idividual program policies may vary. To be cosidered, obtai a Course Substitutio Request form from our Web site at ucsc-extesio.edu/ forms, ad sed your request alog with a course outlie ad descriptio, trascript, ad related fee to the address ad departmet idicated o the form. 4 Certificate Programs Bioscieces Bioiformatics... 9 Biotechology Cliical Trials Desig ad Maagemet Medical Devices Regulatory Affairs Busiess ad Maagemet Accoutig Admiistrative ad Executive Assistat Busiess Admiistratio Huma Resource Maagemet Marketig Maagemet Paralegal Core Paralegal Advaced Persoal Fiacial Plaig Project ad Program Maagemet Advaced Applied Project Maagemet Techical Writig ad Commuicatio Web Cotet Maagemet Educatio Early Childhood Educatio Early Childhood Educatio: Supervisio ad Admiistratio Educatioal Therapy Istructioal Desig for Educators ad Corporate Traiers Teachig Eglish to Speakers of Other Laguages (TESOL) Egieerig ad Techology Computer Programmig Database ad Data Aalytics Embedded Systems Iformatio Techology Iteret Programmig ad Developmet Liux Programmig ad Admiistratio Software Egieerig ad Quality VLSI Egieerig Web ad Iteractive Media Desig Evirometal Health ad Safety Maagemet Evirometal Safety ad Health Maagemet Hazardous Materials Maagemet Occupatioal Safety ad Health Maagemet Cotiuig Professioal Educatio for Licesig, Credetials, Certificatio May courses at UCSC Extesio Silico Valley offer credit ad/or cotiuig educatio uits that apply toward professioal licesig, relicesig or accreditatio, professioal teachig credetials ad credetial reewals, or prepare you for a certificatio exam. To locate courses that apply to your professioal field, please cosult the list below. Accoutats Certified Fiacial Plaers Cliical Research Professioals Educators Evirometal Professioals Hazardous Materials Maagers ad Workers Huma Resource Professioals Idustrial Hygieists Nurses Paralegals Project Maagemet Professioals Regulatory Affairs Professioals... 19
7 New to UCSC Extesio? Start Here Welcome! By opeig this catalog, you ve take the first step toward advac ig your career. UCSC Extesio offers ope erollmet. You may take oe course or a etire certificate. Erollig i a course is a simple process based o your prefereces ad eeds; however, some courses have prerequisites that provide a foudatio for a complete learig experiece. As part of the Uiversity of Califoria, Sata Cruz, UCSC Extesio is certified by the Accreditig Commissio for Seior Colleges ad Uiversities of the Wester Associatio of Schools ad Colleges (WASC). Our classes are ope to everyoe you do t eed to be a UC Sata Cruz studet. Participatig i these educatioal programs does ot i itself provide preferece i admissio to the Uiversity of Califoria. Studets iterested i applyig to UC should refer to the UC Admissios Web site or the admissios office of the UC campus they wish to atted for details about the admissios process. Policy Regardig Course Readers, Textbooks ad Other Istructioal Resources Studets are resposible for obtaiig the required istructioal materials for each course they take. UCSC Extesio courses use a variety of media for istructioal purposes. These vary depedig o the curriculum ad istructor. Please review the sectio details at the bottom of the course descriptio page o our Web site. Istructors may specify ay of the followig: Electroic course materials from our olie learig platform, UCSC Extesio Olie Textbooks (required ad recommeded), see below ad visit ucsc-extesio.edu/bookstore Studets should purchase, order, or access their materials i time to brig them to (or have access to them durig) the first class meetig. For full istructios go to ucsc-extesio.edu/course-materials. Textbook Iformatio Iformatio o required ad recommeded textbooks ca be foud i course descriptios olie at ucsc-extesio.edu, ad o your erollmet receipt. Most textbooks ca be purchased through Extesio s partership with Amazo.com. Our Web site has a coveiet search tool olie at ucsc-extesio.edu/bookstore. Whe ad Where Are Courses Preseted? We make it easy for residets all over the South Bay to cotiue their educatio. Extesio studets ca choose to study i a few differet ways: i state-of-the-art labs ad classrooms at our coveiet Sata Clara locatio; olie, via our dyamic learig platform; ad i hybrid courses, which offer a combiatio of sychroous olie sessios, classroom meetigs, ad olie learig. May of our courses have both olie ad classroom sectios available each quarter to esure that studets with commutes, jobs ad family obligatios ca fid courses that fit their schedules. For a list of olie courses, see page 90. Nearly 95 percet of our courses are offered durig the eveig ad o weekeds. Take advatage of our computer labs, studet louges ad free coffee. Our facility is located right off Highway 101. See page 107 for maps to our campus. Guide to Course Listigs Course Title. Academic umber, approvig campus departmet, uit value (i paretheses). Course descriptio. See ucsc-extesio.edu for expaded course descriptio. If your course requires previous course work or experiece, it will be listed here. Read about your expert istructor i the sectio titled Istructor Biographies. Course locatio or mode of delivery. This is how much the course costs (ot icludig books or material fees uless oted). Please use this Sectio Number to eroll. Tuitio Assistace Displaced or disadvataged workers may be eligible for federal assistace through the Workforce Ivestmet Act (WIA) or the Employmet Develop met Departmet (EDD). Fuds may be applied toward the cost of the Extesio course fees, books, ad materials. For additioal iformatio or to determie eligibility, cotact either your local Workforce Ivestmet Board or Extesio s coordiator at Eroll i Courses at No Cost to You! May of UCSC Extesio s courses qualify for corporate tuitio reimbursemet, especially those that pertai to your curret job or a future positio i your compay. Fid out if your employer offers tuitio reimbursemet. Gradig Grades are available olie at ucsc-extesio.edu, usually withi a moth after a course eds. Those studets who complete a certificate program with a grade-poit average of 4.0 will ear a Certificate with Hoors. A GPA calculator ca be foud at: www2.ucsc.edu/gpacalc. Trasfer of UCSC Extesio Credit Some Extesio courses may be applied toward degrees. Studets are ecour aged to obtai specific iformatio about acceptace of Extesio credit from the admis sios office of the degree-gratig uiversity or college prior to erollig. Fiacial Statemet Aalysis BUSAD. X (4.0 quarter uits) I both the public ad private sectors, maagers must be skilled at coductig research ad aalysis to determie if a firm is a good credit risk or a suitable ivestmet, ad if it ca sustai operatios. This course provides essetial kowledge for the CPA examiatios. It presets fiacial statemets as a set of dyamic istrumets used to support maagemet decisio makig ad protect the public iterest. Prerequisite(s): Itermediate Accoutig I ad Itermediate Accoutig II. RUSS BLAHETKA, D.B.A. SANTA CLARA CLASSROOM 10 meetigs: Modays, 6 10 pm, Jue 20 August 29. Fee: $775. To eroll, use Sectio Number 6938.(039) Cross-Referece Ico The ico at left appears at the bottom of the page throughout the catalog ad is desiged to direct you to other relevat courses. Extesio Studets Are Part of the UCSC Family Extesio studets are cordially ivited to become members of the UCSC Alumi Associatio upo completio of 15 or more uits of credit courses. Call (408) for more iformatio. It s easy to Eroll Olie: Visit our Web site at ucsc-extesio.edu. Credit Card: We accept the followig major credit cards: Visa, MasterCard, America Express ad Discover. By Phoe: Call (408)
8 Iteratioal Studets Our certificate programs are ideal if you are livig i the Bay Area, or abroad, ad wat to: Obtai a studet visa Lear busiess ad techology skills durig your time i the U.S. Fid work opportuities available to those o studet visas after program completio Studyig at UCSC Extesio is a great way to make the most of your time i the U.S. UCSC Extesio professioal certificate programs are located i the heart of Silico Valley. The Valley is the world ceter of cuttig edge techology ad the ecoomic powerhouse of global busiess ad etrepreeurship. Whe studyig with us, you ll iteract with studets ad istructors who work i some of the regio s top compaies. The etworkig opportuities are highly valuable. Thousads of Silico Valley professioals have studied with us ad goe o to successful careers. You ca too. Our iteratioal team ca help you avigate the process of gettig a studet visa. Nearly all of our Professioal Certificate Programs are available to Iteratioal studets. A small umber of certificate programs are coducted etirely olie ad therefore are ot eligible for a studet visa. quarter Witer Applicatio Deadlies We Ca Help with Your Visa Oce you have applied ad bee accepted, UCSC Extesio will issue you a I-20, which ca be used for iitial etry, trasfer, ad chage of status ad reistatemet applicatios. Optioal Practical Traiig (OPT) After completig your certificate program, you ca apply for Optioal Practical Traiig (OPT). OPT is available to studets who have maitaied their studet status for three quarters (approximately ie moths), ad successfully completed a certificate program. With OPT authorizatio, you ca supplemet your high-quality educatio with a year of work experiece i the U.S. Begi Your Studies i Ay Quarter. Iteratioal studet applicatios must be submitted by the followig dates: Quarterly Start/Ed Dates Jauary 1 March 31 If you are IN THE U.S., forms are due: December 15 If you are ABROAD, forms are due: November 15 Some of the most popular Certificates for Iteratioal Studets are: sprig SUMMER April 1 Jue 15 Jue 16 August 31 March 20 Jue 1 February 15 May 1 Computer Programmig Database ad Data Aalytics FALL September 1 December 31 August 20 July 15 Software Egieerig Project ad Program Maagemet Marketig Huma Resources Biotechology TESOL 6
9 witer 2014 Admissio Requiremets Uiversity diploma or equivalet Eglish proficiecy (TOEFL 550 or 80 IBT) Bak statemet demostratig sufficiet fiacial resources Paymet of $150 applicatio fee Paymet of $2,000 iteratioal studet fee How to Apply Details o how to apply ca be foud o our Web site at ucsc-extesio.edu/iteratioal. Our staff is also available to help you pla a course of study ad complete your applicatio. Most studets begi by settig up a meetig with our Iteratioal Program Assistat. Cotact us: Iteratioal Program Assistat Kathy Harrigto Office: (408) Iteratioal Program Represetative Diae Johase Office: (408) Iterships Iteratioal studets erolled i certificate programs are eligible for upaid iterships i their field of study ad have two optios: 1. You ca arrage your ow itership ad register for the itership course, for $ You ca work with the Iteratioal Program Represetative, who will provide outreach ad support i fidig a itership. There is a additioal $250 charge for this service which must be paid i advace. For details, the Iteratioal Program Represetative at ucsc.edu or call to eroll at (408) You ca gai credit for upaid iterships by erollig i UCSC Extesio s itership course, Busiess Practices for Iteratioal Studets, for 3 uits per quarter. I order to receive credit, you must work a miimum of 90 hours durig the quarter. Iters may work more tha 90 hours, but will oly receive a total of 3 uits per quarter. WHAT our StudetS SAY: Motoko Taaka, Japa Computer Programmig Studet Whe I applied from Japa, I was very worried, but every time I cotacted the studet services assistats, they aswered accurately ad quickly. They are experts o visas. Priyaka Redhu, Idia Huma Resource Maagemet ad Marketig Maagemet Studet The program made me feel that I could bled ito the orgaizatio ad work culture. Alejadro Jimeez, Colombia Embedded Systems Studet It was very cool beig aroud people that work i the big compaies you ve always followed. I m pretty sure you ll fid what you eed here. Copyright 2012 The Regets of the Uiversity of Califoria. All Rights Reserved. 7
10 Bioscieces witer 2014 WHAT StudetS SAY gabriela zelaya Regulatory Affairs Studet Gabriela Zelaya had bee workig for the U.S. Commercial Service as a iteratioal trade specialist whe she started takig classes at UCSC Extesio. A commuicatios expert with experiece i iteratioal affairs ad marketig, her professioal domai was expadig to cover the life scieces, ad she eeded to build a critical scietific vocabulary to meet the eeds of her job. Extesio s Regulatory Affairs courses provided the foudatio that she eeded, ot oly to complete projects at work, but to establish a ew biotech sub-team ad spearhead excitig ew projects. Courses Offer Practical Approaches I cover the life scieces for our office i the Bay Area, she says. Our goal is to help small compaies fid parters overseas ad geerate reveues to the hire more people here i the U.S. I eeded to be able to uderstad what my cliets were sayig, what challeges they were facig, ad Extesio s classes defiitely gave me that isight. My office paid for the first few classes, ad the I liked the program so much that I decided to complete the certificate i Regulatory Affairs. Zelaya says that Extesio s courses were rigorous, coverig everythig from drug discovery ad developmet to regulatory submissios, FDA approval processes ad cliical trials. Real-World Skills, Real-World Kowledge I ve bee able to traslate what I leared to real life, to how we support life sciece compaies, she says. I eeded this extesive kowledge of the life scieces to be able to do all this. Tell Us Your Story We d love to hear how you applied ew skills i the workplace, or how your ew credetials led to excitig job opportuities. Share your latest achievemets by submittig your Extesio story to Completig the certificate really boosted my positio i terms of kowledge i my idustry. 8 Register olie today with just a few clicks o our Web site. Visit ucsc-extesio.edu.
11 Bioscieces Bioiformatics Bioiformatics Certificate Program Bioiformatics Certificate Cotact Applied ad Natural Scieces Departmet, (408) , or Program Summary Biological data cotiue to accumulate at a pheomeal rate. UCSC Extesio s Bioiformatics Certificate Program was created i cosultatio with idustry leaders to meet the eed for biologists ad computer scietists with the ability to aalyze ad iterpret this deluge of biological iformatio. Courses i this program are taught by experieced molecular biologists ad bioiformatics professioals who brig real-world perspectives ad cuttig-edge techologies ito their classrooms. The Bioiformatics Certificate provides theoretical foudatios ad practical skills i bioiformatics. The required courses provide the ecessary computatioal ad scietific foudatios. A rage of electives allows idividuals to tailor their studies to their particular eeds ad iterests. Life scietists lear how to effectively use the tools ad methods of bioiformatics to ehace their work, while computer scietists gai a backgroud i molecular biology ad importat bioiformatics methods ad tools. This program is desiged for studets who have a degree i biology, biochemistry, or computer sciece who wat to erich their careers by learig ad applyig the key priciples ad practices of bioiformatics. Certificate Requiremets To satisfy the requiremets for the Certificate i Bioiformatics, you must complete three required courses ad 7 uits of electives, for a miimum total of 16 uits. For GPA requiremets ad program time limits, see page 4. To pursue two biosciece-related certificates i parallel or i sequece, see page 10. Prerequisites Familiarity with the priciples of moder molecular biology is required. Completio of Molecular Biology, Itroductio or a equivalet course withi the last five years, or equivalet experiece satisfies this requiremet. A uderstadig of probability ad statistics is required for Statistical Aalysis ad Modelig for Bioiformatics ad Biomedical Applicatios. Studets without this backgroud should first complete Statistics or Statistical Desig of Experimets: A Practical Approach, or the equivalet prior to takig Statistical Aalysis ad Modelig for Bioiformatics ad Biomedical Applicatios. Recommeded Course Sequece Those ew to the field of bioiformatics should start with Bioiformatics Tools, Databases ad Methods ad/or Experimetal Methods i Molecular Biology (after completig the prerequisites). Courses may the be take i ay sequece uless otherwise specified i the idividual course descriptio. Courses may be take idividually or as part of the certificate program. For More Iformatio Curret ad future course schedules ca be foud at ucsc-extesio.edu/bioscieces. For more iformatio o this program or to be added to our mailig list, please call (408) or cotact For Certificate Applicatio Iformatio ad Policy o Trasferrig Credit from Other Schools, see page 4. Prerequisite Courses Molecular Biology, Itroductio NATSC.X425.9 (3.0 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 30.0 hours. This course provides a comprehesive itroductio to molecular biology for obiologists ad a review for those who wat to refresh ad update their kowledge of this subject. Topics iclude fudametal cocepts of gees ad proteis, cetral dogma ad the geetic code; structure ad fuctio of gees; gee expressio, trascriptio ad traslatio; protei structure ad fuctio; itroductio to geetics; Medelia aalysis; molecular ad populatio geetics, geetic markers ad maps; ad the impact of moder molecular biology o sciece ad medicie. The course also icludes a overview of experimetal methods used i molecular biology, such as recombiat DNA, PCR, gee cloig, ad gee expressio aalysis. Prerequisite(s): College-level biology is recommeded. SAMI KHURI, M.S., Ph.D. 10 meetigs: Modays, 6 9 pm, Jauary 13 March 31 (o meetig Ja. 20 ad Feb. 17). Fee: $675. To eroll, use Sectio Number 4213.(081) Statistics AMS.X (5.0 quarter uits) This course explores the fudametals of statistical methods ad reasoig. Topics iclude descriptive methods, data gatherig, probability, iterval estimatio, sigificace tests, oe- ad two-sample problems, categorical data aalysis, correlatio ad regressio. The istructor will demostrate the use of spreadsheets ad statistical software to aalyze ad iterpret data. Examples are draw from a variety of fields icludig biology, busiess ad marketig. While ot too mathematically rigorous for the ovice, the course provides some mathematical detail to illustrate basic cocepts. No prior backgroud i calculus or statistics is required. istructor TBA. ONLINE, Jauary 7 March 31. Erollmet accepted through February 28. Fee: $860. To eroll, use Sectio Number (010) bioscieces IN THIS SECTION w Bioiformatics 9 w Biotechology 11 w Cliical Trials Desig ad Maagemet 14 w Medical Devices 18 w Regulatory Affairs 19 Bioscieces UCSC Extesio Silico Valley is the mai source for professioal developmet traiig i Bioscieces i the Bay Area. Our courses ad programs meet the eeds of Bay Area compaies ad ew ad experieced idustry professioals. Taught by experts from Silico Valley s biotechology, pharmaceutical, ad medical device sectors, our courses offer participats the kowledge base, idustry perspectives, ad importat coectios eeded to build a strog career. May of our bioscieces certificate programs are kow throughout the idustry as uparalleled i rigor ad quality. Whether you are iterested i learig about the scietific, cliical, computatioal, regulatory or busiess aspects of the biosciece fields, UCSC Extesio Silico Valley ca help you succeed. Featured WINTER Courses Cliical Trials Essetials: A Itesive Oe-Week Workshop Biotechology Basics for No-Scietists Mobile Medical Applicatios Molecular Biology, Itroductio... 9 SAS Programmig for Cliical Trials Statistics... 9 Viruses, Vaccies ad Gee Therapy Copyright 2014 The Regets of the Uiversity of Califoria. All Rights Reserved. 9
12 Bioiformatics Bioscieces 16-uit miimum BIOINFORMATICS CERTIFICATE Prerequisite Courses uits Course F W Sp Su Molecular Biology, Itroductio AND Statistics OR m m m m Statistical Desig of Experimets: A Practical Approach Required Courses uits Course F W Sp Su Bioiformatics Tools, Databases ad Methods m m Experimetal Methods i Molecular Biology m Statistical Aalysis ad Modelig for Bioiformatics ad Biomedical Applicatios m Elective Courses (7 uits required) Uits Course F W Sp Su Take required courses before electives. Computatioal Biology with Java DNA Microarrays: Priciples, Applicatios ad Data Aalysis m m Drug Discovery, Itroductio Gee Expressio ad Pathways Perl for Bioiformatics Sequece Aalysis i Bioiformatics, Advaced Structure Aalysis of Biological Molecules Ay oe course from UCSC Extesio s Biotechology Certificate may be applied toward the elective uit requiremet for the Bioiformatics Certificate Program. held i classroom m offered olie p both classroom ad olie sessios are available Visit ucsc-extesio.edu for the most curret program schedule. Required Courses Bioiformatics Tools, Databases ad Methods CMPS.X446.4 (3.0 quarter uits) This practical course itroduces the mai public domai tools, databases ad methods used i bioiformatics, icludig DNA ad protei databases such as Gebak ad PBD, software tools such as BLAST, ad methods for aligig sequeces. Other topics iclude multiple aligmet, phylogeetic aalysis, microarrays ad system biology. The course emphasizes the eeds of the user of bioiformatics tools ad databases, rather tha complex algorithm developmet ad advaced computatioal methods. Studets lear through computer lab exercises ad olie demostratios of databases ad tools o the Web. This is the recommeded first course for those watig to gai skills i bioiformatics. Prerequisite(s): Molecular Biology, Itroductio. JANANI RANGARAJAN, M.S. ONLINE, Jauary 7 March 31. Erollmet accepted through February 28. Fee: $765. To eroll, use Sectio Number 2447.(050) Experimetal Methods i Molecular Biology NATSC.X446.5 (3.0 quarter uits) This lecture-based course provides a theoretical overview of the key molecular biology techiques used i basic life sciece research ad by the biotechology ad biopharmaceutical idustry for the discovery of ovel therapeutics. Topics iclude gee cloig, maipulatio ad sequecig; PCR; RNA iterferece; gee expressio aalysis; protei expressio, egieerig, ad structure determiatio; ad the fudametals of experimetal desig. Also addressed are high-throughput sequecig ad microarray expressio aalysis ad the types of data these techiques geerate. Prerequisite(s): Molecular Biology, Itroductio. JUAN JOSÉ FUNG, Ph.D. ONLINE, Jauary 7 March 31. Erollmet accepted through February 28. Fee: $765. To eroll, use Sectio Number 1912.(041) Lear More for Less Do you kow that you ca complete two biosciece certificate programs at UCSC Extesio, simultaeously or i sequece, with fewer uits tha if the programs were take idividually? Studets pursuig two certificates eed to complete the total umber of uits idicated i the table below, icludig all the required courses for both programs. I order to obtai two certificates with the fewest umber of uits, studets must select some electives that are commo to both programs. Please cotact ucsc.edu or call (408) if you eed more iformatio or would like assistace creatig a study pla. Biotechology Cliical Trials Medical Devices Regulatory Affairs Bioiformatics Biotechology 19 uits 32 uits 31 uits 32 uits 30 uits Cliical Trials 32 uits 19 uits 31 uits 32 uits X Medical Devices 31 uits 31 uits 17 uits 31 uits X Regulatory Affairs 32 uits 32 uits 31 uits 19 uits X Bioiformatics 30 uits X X X 16 uits 10 Register olie today with just a few clicks o our Web site. Visit ucsc-extesio.edu.
13 Elective Courses Gee Expressio ad Pathways NATSC.X426.2 (2.0 quarter uits) This course provides a solid foudatio i the molecular cocepts ad cuttig-edge techologies that are cetral to the uderstadig of gee expressio pathways i simple cells ad complex multicellular orgaisms. Topics iclude gee structure; regulatory proteis ad trascriptioal cotrol; iheritace of states of gee expressio; ad posttrascriptioal cotrol of gee activity. Abormalities i gee expressio are discussed i relatio to huma disease states as well as drug discovery ad diagostic medicie. Prerequisite(s): Molecular Biology, Itroductio. Prior molecular biology course work or backgroud is strogly recommeded. AMITABHA CHAUDHURI, Ph.D. 3 meetigs: Saturdays, 8:30 am 5 pm, March 8 29 (1 o meetig TBA). Fee: $715. To eroll, use Sectio Number 6020.(025) Structure Aalysis of Biological Molecules CMPS.X455.4 (2.0 quarter uits) The three-dimesioal structure of a biological molecule is a critical determiat of its fuctio. This course addresses the experimetal ad computatioal methods for determiig three-dimesioal molecular structure, with a primary focus o proteis. Studets explore the cocepts that uderlie protei-based drug desig, protei structure databases, protei structure classificatio methods, ad physiochemical techiques for structural aalysis of biological macromolecules. Theoretical ad computatioal tools used for protei structure aalysis, structure aligmet, ad protei structure predictio are also covered. Oe sessio is devoted to ucleic acid structure determiatio. Prerequisite(s): Experimetal Methods i Molecular Biology, Bioiformatics Tools, Databases ad Methods ad Molecular Biology, Itroductio. LELAND KOZAR, M.A., M.S., M.B.A. SANTA CLARA LAB WITH ONLINE MATERIALS 3 meetigs: Saturdays, 9 am 4 pm, November 9 December 7 (o meetig Nov. 30 ad 1 o meetig TBA). Fee: $825. To eroll, use Sectio Number 5925.(014) Biotechology Certificate Program Biotechology Certificate Cotact Applied ad Natural Scieces Departmet, (408) , or Program Summary The Bay Area is a leader i the global biophar maceutical idustry, with local compaies ad research istitutios settig the pace i the discovery ad developmet of biopharmaceuticals to target major umet medical coditios, such as cardiovascular disease, cacer, AIDS ad other degeerative diseases. The Biotechology Certificate equips professioals with a rich backgroud i the priciples, processes ad cuttig-edge techologies cetral to biotechology. This combiatio of geeral ad practical kowledge ehaces the skills of professioals curretly workig i this idustry ad helps prepare others to eter this dyamic field. The certificate program provides a solid uderstadig of the scietific disciplies that uderlie the idustry s activities, a foudatio i the priciples that guide drug discovery ad developmet, a appreciatio of cuttig-edge biosciece research ad techology, ad a broader awareess of today s biopharmaceutical idustry. This program beefits professioals from all disciplies who wat to develop a solid scietific foudatio i the priciples ad applicatios of biotechology, i order to work more effectively i or trasitio ito the biopharmaceutical sector. Certificate Requiremets To satisfy the requiremets for the Certificate i Biotechology, you must complete the four required courses as idicated i both Core A ad B, ad 8 uits of electives from Track 1 ad Track 2, for a miimum total of 19 uits. For GPA requiremets ad program time limits, see page 4. To pursue two biosciece-related certificates i parallel or i sequece, see page 10. Prerequisites Familiarity with the priciples of moder molecular biology is required. Completio of Molecular Biology, Itroductio or a equivalet course take withi the last five years, or equivalet experiece satisfies this requiremet. Please direct questios about the suitability of a prerequisite to For those ew to the idustry, we recommed that Biotechology Basics for No-Scietists be take prior to startig other course work. Recommeded Course Sequece We recommed that you begi with Drug Discovery, Itroductio or Drug Developmet Process. After that, you may take courses i ay sequece, uless otherwise specified. Courses may be take idividually or as part of the certificate program. For More Iformatio Curret ad future course schedules ca be foud at ucsc-extesio.edu/bioscieces. For more iformatio o this program or to be added to our mailig list, please call (408) or cotact Bioscieces Bioiformatics / Biotechology Ifo Sessio Biotechology ad Bioiformatics Are you iterested i learig about the Bioiformatics ad Biotechology certificate programs, ad about careers i these fields? This special free iformatio sessio provides a opportuity to meet istructors ad other studets, lear about program prerequisites, course cotet ad program requiremets, ad see how these programs ca help you advace your curret career or break ito a ew field. SANTA CLARA CLASSROOM Moday, 6 8:30 pm, Jauary 6. No fee, but registratio required. To eroll, use Sectio Number (018) You May Be Closer to a Certificate Tha you realize Are you just a few courses away from earig a biosciece certificate? Let us review your academic record ad help to fast track your goals. Cotact us to develop a persoalized study pla: Copyright 2014 The Regets of the Uiversity of Califoria. All Rights Reserved. 11
14 Biotechology Bioscieces For Certificate Applicatio Iformatio ad Policy o Trasferrig Credit from Other Schools, see page 4. Prerequisite Course Molecular Biology, Itroductio For course descriptio, see page 9. Required Courses: Core A Drug Developmet Process NATSC.X428.2 (2.0 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 24.0 hours. The developmet of ew drugs is a complex, legthy, ad expesive process. I this course, we examie this process from discovery to market ad beyod ad see what makes the biopharmaceutical idustry uique. Ifused with real-world examples, lectures address drug discovery; precliical characterizatio of ew drug etities; the phases ad purposes of both pharmacological ad cliical developmet; regulatory filigs, compliace ad oversight; FDA jurisdictio; ad strategic issues i drug developmet. The course provides a importat foudatio i drug developmet for professioals from all disciplies who are curretly workig i, or are cosiderig a move to, the biopharmaceutical idustry. EDWARD ROZHON, Ph.D. 10 meetigs: Thursdays, 6 9 pm, Jauary 16 March 27; Saturdays, 9 am 4 pm, March (3 o meetigs TBA). Fee: $765. To eroll, use Sectio Number 6559.(048) ACCESS TO ONLINE COURSES AND MATERIALS If you are erollig for the first time i a Olie course, or a classroom course with Olie Materials, you will receive a accout for UCSC Extesio Olie via withi 12 hours. If you have previously take a course with olie materials, you should use your existig accout. Course sites will ope oe day prior to the official start date. For more iformatio, icludig help retrievig your accout ifo, please visit ucsc-extesio.edu/olie-faqs. For iformatio o textbooks, see page 95 or visit ucsc-extesio.edu/bookstore. 19-uit miimum BIOTECHNOLOGY CErtificatE Prerequisite Course uits Course F W Sp Su Molecular Biology, Itroductio Required Courses A AND B (four) uits Course F W Sp Su Core A Both required Drug Discovery, Itroductio Drug Developmet Process Core B Choose 2 of 4 Biochemistry, A Itroductio Cellular Biology m Experimetal Methods i Molecular Biology m Immuology, Priciples Elective Courses uits Course F W Sp Su (8 uits required; at least oe uit must be from each track.) Track 1: Discovery Biology of Cacer DNA Microarrays Priciples, Applicatios ad Data Aalysis m m Gee Expressio ad Pathways Huma Physiology i Health ad Disease Mass Spectrometry i Drug Discovery Stem Cell Biology Toxicology Basics for Biotechology m m m m Viruses, Vaccies ad Gee Therapy Track 2: Developmet Drug Quality Fudametals: Quality Cotrol of Small Molecules ad Biologics Good Maufacturig Practices Itellectual Property Essetials for the Life Scieces, High-Tech, Software, ad Other Techology Areas Molecular Diagostics Naotechology, Itroductio Reactive Kietics Fudametals Regulatio of Drugs ad Biologics Statistical Desig of Experimets: A Practical Approach Recommeded Course uits Course F W Sp Su Biotechology Basics for Biotechology Data Privacy ad Security for Healthcare ad Bioscieces Ay oe course from UCSC Extesio s Bioiformatics, Cliical Trials Desig ad Maagemet, Medical Devices or Regulatory Affairs Certificate Programs may be applied toward the elective uit requiremet for the Biotechology Certificate. held i classroom m offered olie p both classroom ad olie sessios are available Visit ucsc-extesio.edu for the most curret program schedule. 12 Register olie today with just a few clicks o our Web site. Visit ucsc-extesio.edu.
15 Bioscieces Biotechology Required Courses: Core B Experimetal Methods i Molecular Biology For course descriptio, see page 10. Immuology, Priciples NATSC.X426.3 (3.0 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 30.0 hours. Explore the fudametal priciples of immuology alog with recet developmets i the field ad their implicatios for drug discovery ad developmet, as well as disease treatmet. Topics iclude iate, humoral ad cell-mediated immuity; the cloal selectio of lymphocytes; atiges, atibodies ad their iteractios; atibody gee rearragemet; lymphocyte developmet; ad aspects of cliical immuology such as iflammatio. Also covered are the immue respose to bacterial, viral, fugal ad parasitic diseases; vaccies; AIDS ad other immuodeficiecies; autoimmue diseases; allergies; trasplatatio immuology; ad cacer. Throughout the course, immuological techiques importat i research ad cliical laboratories are highlighted. Prerequisite(s): Kowledge of geeral microbiology ad basic chemistry. Kowledge of cell biology is recommeded. SREENIVASAN PARUTHIYIL, Ph.D. 9 meetigs: Tuesdays, 6 9:30 pm, Jauary 14 March 18 (1 o meetig TBA). Fee: $765. To eroll, use Sectio Number 2257.(028) Elective Courses Track 1: Discovery Gee Expressio ad Pathways For course descriptio, see page 11. Huma Physiology i Health ad Disease BIOL.X (3.0 quarter uits) This course itroduces the fudametal priciples of huma physiology i health ad disease, ad provides isights ito the cuttig-edge ad established therapies beig developed ad used to treat a rage of disease processes. Desiged for idividuals who have o formal medical traiig, the course begis with a overview of the hierarchical orgaizatio of the body, from cells to coordiated orga systems, ad cotiues with a discussio of the key itegrative/homeostatic cotrol mechaisms. With these topics as a foudatio, the istructor progresses through the fuctios of major systems icludig real, cardiovascular, respiratory, euromuscular, digestive, edocrie ad reproductive. PRATHIMA KALASBAIL, M.B.B.S., D.A. 12 meetigs: Thursdays, 6 9 pm, Jauary 16 April 3. Fee: $765. To eroll, use Sectio Number 6999.(015) Toxicology Basics for Biotechology NATSC.X429.3 (1.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 15.0 hours. Biopharmaceutical compaies exped vast resources to idetify ew chemical ad biological agets that have the potetial for cliical beefit. However, before these ca be tested ad used widely i patiets, safety ad acceptable toxicity to critical orgas must be demostrated. This course surveys the adverse effects resultig from the iteractio of chemical agets with livig systems. Topics iclude criteria ad mechaisms of toxicity, dose-respose relatioships, factors ifluecig toxic actio, acute ad chroic effects, kietics, metabolism, ad toxicity testig. Applicatios i both pharmacology ad drug developmet are discussed. Prerequisite(s): Completio of at least oe college-level chemistry course. RONALD TJEERDEMA, Ph.D., D.A.B.T. ONLINE, Jauary 7 March 31. Erollmet accepted through February 28. Fee: $580. To eroll, use Sectio Number 2310.(016) Viruses, Vaccies ad Gee Therapy NATSC.X (1.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 15.0 hours. Iteractive case studies ad Web-supplemeted lessos drive our exploratio of the iterplay of viruses with their cellular hosts. Buildig o these foudatios, we examie saliet topics i vaccies, gee therapy ad therapeutic viruses. Pertiet ad real issues relevat to the biopharmaceutical idustry are also discussed. Course topics iclude virus evolutio, emergig viruses, the risks ad beefits of vaccies, the polio eradicatio campaig, epidemiology of iflueza, HIV-1 vaccies, ad the trials ad tribulatios of gee therapy. MOLLY OHAINLE, Ph.D. SANTA CLARA LAB WITH ONLINE MATERIALS 5 meetigs: Modays, 6 9 pm, Jauary 13 March 10 (o meetigs Ja. 20, Feb, 17 ad 2 o meetigs TBA). Fee: $580. To eroll, use Sectio Number 6974.(012) Elective Courses Track 2: Developmet Good Maufacturig Practices For course descriptio, see page 20. Also of Iterest Biotechology Basics for No-Scietists NATSC.X426.8 (0.5 quarter uit) CA BRN/LVN Credit Provider #CEP13114, 6.0 hours. Desiged for o-scietists, this oe-day course begis with a accessible overview of the basic cocepts i molecular biology ad geetics that serve as a foudatio for biotechology. The istructor the highlights gee-based techology ad importat biotechology breakthroughs, especially as they relate to Bay Area compaies, ad explores the impacts ad the future of this cuttig-edge disciplie. Studets leave the course with a ew vocabulary ad a solid uderstadig of the power ad potetial of biotechology. MARCEL DAADI, Ph.D. Saturday, 9 am 4 pm, Jauary 11. Fee: $325. To eroll, use Sectio Number 6163.(026) Cliical Trials Essetials: A Itesive Oe-Week Course For course descriptio, see page 17. Copyright 2014 The Regets of the Uiversity of Califoria. All Rights Reserved. 13
16 Cliical Trials Bioscieces Cliical Trials Certificate Program Cliical Trials Desig ad Maagemet Certificate Cotact Applied ad Natural Scieces Departmet, (408) , or Program Summary The Bay Area ad Silico Valley are leaders i the global biopharmaceutical ad medical device idustries. The cotiued success of these idustries relies o cliical trials the complex process of esurig the safety ad effectiveess of ew ad existig medical products. UCSC Extesio s Certificate i Cliical Trials Desig ad Maage met is uparalleled i rigor ad quality. It helps professioals gai a solid ad practical uderstadig of the etire cliical trials process, from drug ad device developmet to moitorig, as well as a foudatio i the scietific priciples, regulatios ad ethics that are vitally importat to the coduct of cliical research. Because of its comprehesive curriculum ad itese focus o best practices i the cliical trial process, this certificate is appropriate for curret professioals cliical research associates ad coordiators, cliical program maagers ad physicias, biomedical ad research scietists, urses, IRB members ad admiistrators, ad pharmacists as well as those ew to the field. May courses i this program qualify for recertificatio CEUs for those certified as CCRAs ad CCRCs through ACRP. Most courses also grat BRN credit for ursig professioals. Certificate Requiremets To obtai the Certificate i Cliical Trials Desig ad Maagemet, you must complete 6 required courses ad 6 uits of elective courses, for a miimum total of 19 uits. For GPA requiremets ad program time limits, see page 4. To pursue two biosciece-related certificates i parallel or sequece, see page 10. Courses may be take idividually or as part of the certificate program. Prerequisites Successful completio of Medical/Cliical Termiology, a equivalet course, or medical traiig is required. We strogly recommed that studets without a medical backgroud take Huma Physiology i Health ad Disease early i their studies. Recommeded Course Sequece We recommed that you begi the program with Drug Developmet Process after completig the prerequisites. You may the take courses i ay sequece, uless otherwise specified. For More Iformatio Curret ad future course schedules ca be foud at ucsc-extesio.edu/bioscieces. For more iformatio o this program or to be added to our mailig list, please call (408) or cotact CLINICAL TRIALS DESIGN AND MANAGEMENT CErtificatE 19-uit miimum Prerequisite Courses uits Course F W Sp Su Medical/Cliical Termiology ceu Huma Physiology i Health ad Disease (Recommeded) Required Courses uits Course F W Sp Su Drug Developmet Process Medical Devices: Regulatory Strategies ad Marketig Pathways Good Cliical Practices Cliical Trials Site Moitorig I Sciece of Cliical Trials Desig Cliical Statistics for No-Statisticias Elective Courses (6 uits required) Uits Course F W Sp Su Adverse Evet ad Medicatio Codig: A Itroductio to MedDRA ad WHO-Drug m m m m Case Report Forms Developmet Cliical Data Maagemet Cliical Project Maagemet Cliical Research: The Study Site Perspective m m m m Cliical Trials Site Moitorig II Cotractig with Cotract Research Orgaizatios (CROs) Developmet of Cliical Stadard Operatig Procedures Documet Preparatio: Protocols, Reports, Summaries Drug Safety ad Adverse Evets Reportig Electroic Data Capture for Cliical Trials Global Coduct of Cliical Trials Good Maufacturig Practices Medical Writig s s Preparig for FDA Ispectios ad Coductig Sposor Audits SAS Programmig for Cliical Trials SAS for Cliical Trials for the No-Programmer, Itroductio Recommeded Course uits Course F W Sp Su Data Privacy ad Security for Healthcare ad Bioscieces Ay oe course from UCSC Extesio s Regulatory Affairs Certificate Program may be applied toward the elective uit requiremet for the Cliical Trials Desig ad Maagemet Certificate. held i classroom m offered olie s hybrid p both classroom ad olie sessios are available For Certificate Applicatio Iformatio ad Policy o Trasferrig Credit from Other Schools, see page 4. Visit ucsc-extesio.edu for the most curret program schedule. 14 Register olie today with just a few clicks o our Web site. Visit ucsc-extesio.edu.
17 Bioscieces Cliical Trials Prerequisite Course Medical/Cliical Termiology NATSC.814. (0.7 CEUs) A basic uderstadig of medical ad cliical termiology is essetial i cliical trials desig ad maagemet. This iteractive workshop, for idividuals with o backgroud i medical/cliical termiology or for those who would like a refresher, reviews commo terms associated with medical research ad developmet ad cliical trials. Participats review both the meaig of each term ad how it is applied withi a practical cotext. ADDY ALSUMDE, M.D., Ph.D. Saturday, 9 am 5 pm, Jauary 11. Fee: $325. To eroll, use Sectio Number 2928.(067) Recommeded Prerequisite Course Huma Physiology i Health ad Disease For course descriptio, see page 13. Required Courses Cliical Statistics for No-Statisticias NATSC.X424.8 (2.0 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 24.0 hours. Cliical studies succeed or fail o the stregth of their statistics. This course takes a practical approach to fudametal statistical cocepts essetial for ostatisticias ivolved i cliical research. Through lectures, discussios ad i-class exercises, the istructor explores cliical study desigs, hypothesis testig, sample size calculatios, assumptios, cotrols, edpoits, datamaagemet priciples, data presetatios ad aalysis plas, methods of aalysis, ad coclusios. Participats lear how to iterpret statistics commoly ecoutered i cliical research as well as how to commuicate effectively with statisticias. The approach is practical, simple ad qualitative. No previous backgroud i statistics is required. PETER SHABE, M.S. 8 meetigs: Tuesdays, 6 9 pm, Jauary 14 March 11 (1 o meetig TBA). Fee: $750. To eroll, use Sectio Number 2345.(040) Cliical Trials Site Moitorig I NATSC.X424.3 (2.0 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 21.0 hours. This course itroduces the essetial elemets of moitorig a cliical trial ad delieates the roles ad resposibilities of the sposor, study site ad the FDA. Participats gai isight ito the iteractios betwee sposors ad study sites. They are exposed to the process of site selectio, budgetig, iitiatio visits, source documetatio, regulatory documetatio, ad adverse evet reportig. Also addressed are some practical tools for use i trackig compliace, product accoutability ad medical record review. Prerequisite(s): Good Cliical Practices or equivalet course or experiece. SAVITA SINHA, M.Sc. 4 meetigs: Fridays, 5 9 pm, March 7, 14; Saturdays, 9 am 5 pm, March 8, 15. Fee: $750. To eroll, use Sectio Number 0608.(052) Drug Developmet Process For course descriptio, see page 12. Medical Devices: Regulatory Strategies ad Marketig Pathways NATSC.X425.6 (1.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 15.0 hours. Medical devices are uiquely differet from drugs ad biologics i their regulatio ad paths to market. Effective cliical trial coduct for devices requires a solid uderstadig of these issues. This course provides a foudatio i the regulatio of medical devices, ad it icludes discussios of device classificatio, ivestigatioal device exemptios (IDE), 510(K) ad PMA submissios, ad maagig ad reportig adverse device evets (MDRs). Note(s): Studets pursuig the Cliical Trials Certificate who are also iterested i the Regulatory Affairs Certificate may take Regulatio of Medical Devices ad Diagostics to fulfill the Medical Devices: Regulatory Strategies ad Marketig Pathways requiremet i the Cliical Trials Program. NANCY E. ISAAC, J.D., M.P.H., M.S. ANNA LONGWELL, J.D., M.B.A. 5 meetigs: Wedesdays, 6 9 pm, Jauary 15 March 5 (3 o meetigs TBA). Fee: $675. To eroll, use Sectio Number 5939.(032) Ifo Sessio Cliical Trials, Regulatory Affairs, ad Medical Devices Are you iterested i learig about the Cliical Trials, Regulatory Affairs, ad Medical Device certificate programs, ad about careers i these fields? This special iformatio sessio provides a opportuity to meet istructors ad other studets, lear about program prerequisites, program philosophy, course cotet ad program requiremets, ad gai isights ito careers i cliical research, regulatory affairs, ad medical devices. SANTA CLARA CLASSROOM Wedesday, 6 8:30 pm, Jauary 8. No fee, but registratio required. To eroll, use Sectio Number (018) ACRP Cotact Hours May of the required ad elective courses i UCSC Extesio s Cliical Trials Certificate Program qualify as cotact hours toward ACRP recertificatio. See the Associatio of Cliical Research Professioals Web site at acrpet.org for certificatio iformatio. BRN: Board of Registered Nursig All courses desigated BRN are approved for cotiuig educatio hours for RNs ad LVNs (Provider #CEP13114). RAPS Credit May of the required ad elective courses i UCSC Extesio s Cliical Trials ad Regulatory Affairs certificate programs qualify for poits toward recertificatio for RAC. See the Regulatory Affairs Profes sioals Society Web site at for details. Copyright 2014 The Regets of the Uiversity of Califoria. All Rights Reserved. 15
18 Cliical Trials Bioscieces Sciece of Cliical Trials Desig NATSC.X424.2 (2.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 25.0 hours. This course addresses the sciece that forms the basis of effective cliical trial desig. Topics iclude classifyig ad describig trial desig by stage i drug ad device developmet; reasos for cliical trials; types of trial desigs; defiig the hypothesis ad study objectives; determiig the populatio ad sample size; stoppig rules; stadards of practice versus FDA requiremets; safety iformatio ad data safety moitorig boards; scietific ad ethical cosideratios; validity of desig, executio, aalysis, ad reportig. Prerequisite(s): Good Cliical Practices, ad Drug Developmet Process. MICHAEL HUSTON, M.B.A., B.S. 6 meetigs: Thursdays, 5:45 10 pm, Jauary 16 March 6 (2 o meetigs TBA). Fee: $765. To eroll, use Sectio Number 3657.(053) Staford Cliical Research Itership Program for Graduates of UCSC Extesio s Cliical Trials Desig ad Maagemet Certificate Program Qualifyig graduates from the Cliical Trials Desig ad Maagemet Certificate Program may have the opportuity to brig their course work to life ad gai valuable experiece i a cliical research settig at Staford. Space is limited. If iterested, please cotact (408) or Elective Courses Adverse Evet ad Medicatio Codig: A Itroductio to MedDRA ad WHO-Drug NATSC.X (1.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 15.0 hours. Codig dictioaries, particularly MedDRA, are importat i the U.S. ad Europe for the electroic trasmissio of adverse evet reportig, both i the pre- ad postmarketig areas ad i the codig of cliical trial data. This course provides a uique local opportuity for a itroductio ito how adverse evets ad medicatio terms are coded ad the use of commercial codig browsers. Studets gai familiarity ad hads-o experiece with the dictioaries used i the pharmaceutical ad biotechology idustries, icludig MedDRA, ad WHO-Drug. The course is desiged for drug safety specialists, cliical data maagers, cliical data coordiators, cliical research associates, medical coders, ad others with medical backgrouds who are iterested i these roles withi the biopharmaceutical idustry. Prerequisite(s): Medical/Cliical Termiology. MARIE LOU MUNSON, M.D., M.P.H. ONLINE, Jauary 7 March 31. Erollmet accepted through February 28. Fee: $825. To eroll, use Sectio Number (013) Case Report Forms Developmet NATSC.X425.1 (1.0 quarter uit)ca BRN/LVN Credit Provider #CEP13114, 10.0 hours. Case report forms (CRFs) are the tools used i cliical trials to collect data about subjects from ivestigator sites. A CRF must traslate the cliical protocol i such a way as to collect data that will support the plaed aalyses. The CRF must also accommodate the may problems that arise i the real world of cliical sites ad subjects. We will discuss how the idustry CDISC data stadards ca assist with CRF developmet ad throughout the cliical research process. Studets will view ad discuss may cocrete examples ad optios for CRF modules that demostrate how the CRF impacts all of the groups ivolved i the coduct of the cliical trial. Prerequisite(s): Drug Developmet Process or equivalet course or experiece. LAURA GARDNER, M.S. 2 meetigs: Friday Saturday, 9 am 3 pm, February 28, March 1. Fee: $495. To eroll, use Sectio Number 5544.(023) Cliical Project Maagemet BUSAD.X480.4 (2.0 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 20.0 hours. This course addresses critical elemets i the effective plaig ad maagemet of cliical trials. Exercises ad case studies illustrate how to develop ad maage activities, timelies ad budgets; examie staffig ad resource requiremets; ad lead ad motivate effective teams. Strategic developmet plas, team ad site performace problems, ad post-marketig studies are also discussed. This course will beefit cliical research professioals with a solid foudatio i drug developmet, GCP ad moitorig who are begiig to maage cliical trials. ROSH (KAKUBHAI) VORA, Ph.D. 6 meetigs: Thursdays, 5 9 pm, March 13 May 1 (2 o meetigs TBA). Fee: $750. To eroll, use Sectio Number 2315.(020) Cliical Research: The Study Site Perspective NATSC.X (1.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 15.0 hours. This course offers practical isight ito the cliical research process from the viewpoit of the study site. Lectures ad class exercises explore the roles, resposibilities, iteractios, ad cocers of study site persoel ad highlights importat differeces i perspective betwee cliical study sites ad idustry sposors. The cotet applies to all study sites icludig academic medical ceters, commuity hospitals, rural cliics, physicia private practices, hospital etworks, ad Phase 1 uits. Whether you work at a study site, for a sposor, or are iterested i opportuities at these orgaizatios, this course will provide you with a deeper uderstadig of the study site s role i cliical research. Prerequisite(s): Good Cliical Practices. JESSICA STURM, M.P.H., RN. ONLINE, Jauary 7 March 31. Erollmet accepted through February 28. Fee: $580. To eroll, use Sectio Number (014) Cotractig with Cotract Research Orgaizatios (CROs) BUSAD.X477.9 (1.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 15.0 hours. Pharmaceutical ad biotechology compaies are more ad more frequetly usig the services of cotract research orgaizatios (CROs) to access expertise or techology ot available i-house for key cliical services. This course takes a practical look at the idetificatio, selectio, ad maagemet of CROs i the performace of cliical projects. Other topics of discussio iclude selectig the best CRO for a project; request for proposal (RFP) compoets; bid review ad egotiatio; types of agreemets; defiig roles ad resposibilities; ad maagig the work oce the cotract is siged. NANETTE NANJO-JONES, B.A., M.B.A. 16 Register olie today with just a few clicks o our Web site. Visit ucsc-extesio.edu.
19 Bioscieces Cliical Trials 2 meetigs: Friday Saturday, 8:30 am 5 pm, March 21, 22. Fee: $580. To eroll, use Sectio Number 5479.(020) Developmet of Cliical Stadard Operatig Procedures NATSC.X428.7 (1.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 15.0 hours. The U.S. federal regulatios ad ICH guidelies for good cliical practice require that all istitutios ad etities ivolved i research with huma subjects develop ad maitai writte stadard operatig procedures (SOPs). However, may compaies do ot develop policies ad SOPs util after huma cliical trials are well uder way. This course examies the regulatory requiremets ad the differeces betwee regulatios, guidelies, policies ad SOPs, ad evaluates the compoets of a well-costructed SOP. Participats develop SOPs for importat cliical fuctios. Prerequisite(s): Good Cliical Practices or equivalet course or experiece. JACQUELINE MARDELL, B.A. SANTA CLARA LAB WITH ONLINE MATERIALS 2 meetigs: Moday Tuesday, 8:30 am 5 pm, March 3, 4. Fee: $580. To eroll, use Sectio Number 1270.(018) Electroic Data Capture for Cliical Trials NATSC.X (1.0 quarter uit)ca BRN/LVN Credit Provider #CEP13114, 10.0 hours. A major tred amog life sciece orgaizatios has bee the recet shift from maual, paper-based cliical data collectio processes to the predomiat use of electroic systems that expedite the availability of accurate cliical trial data. This course examies some of the key issues surroudig the idustry s adoptio of Electroic Data Capture (EDC) ad gives studets the opportuity to use EDC software o classroom computers durig simulated cliical trials. The istructor illustrates the major differece betwee EDC, ad systematically examies the costs, risks, related process chages ad other busiess ad regulatory implicatios of this shift. A sigificat portio of classroom time is devoted to Hads-O EDC activities usig actual commercial EDC systems from idustry-leadig vedors. The course beefits cliical site persoel (primarily study coordiators ad ivestigators) as well as biosciece idustry professioals havig roles i data maagemet, study moitorig, cliical maagemet, ad cliical IT ad IS. JEFFREY SONAS, B.S. SANTA CLARA LAB WITH ONLINE MATERIALS 4 meetigs: Fridays, 6 9:30 pm, Jauary 31, February 7, 21, ad March 21. Fee: $580. To eroll, use Sectio Number (007) Global Coduct of Cliical Trials NATSC.X (1.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 15.0 hours. Usig the U.S. ad E.U. as poits of referece, the istructor ad guest speakers help studets develop a framework by examiig issues ad challeges related to the coduct of cliical trials i established ad emergig foreig markets, icludig Easter Europe, Idia, Chia, ad South America. Lectures ad case studies explore the curret regulatory eviromet; the impact of local laws ad requiremets; cultural challeges ad procedural differeces i trial coduct; how to esure that useful data are collected; ad importat implicatios for huma subject protectio. Prerequisite(s): A uderstadig of Good Cliical Practice (GCP) regulatios ad the cliical trials process, at least at the level that is covered i Drug Developmet Process. JACQUELINE MARDELL, B.A. 5 meetigs: Tuesdays, 6 9 pm, March 18 April 22 (1 o meetig TBA). Fee: $580. To eroll, use Sectio Number (012) Good Maufacturig Practices For course descriptio, see page 20. SAS Programmig for Cliical Trials NATSC.X429.4 (3.0 quarter uits) SAS is the primary software stadard i the biopharmaceutical idustry for the storage, maagemet ad maipulatio of cliical data ad its presetatio to the FDA i cliical trials. Processig cliical data i FDA-regulated idustries has specific requiremets. This course prepares idividuals with SAS programmig experiece to process cliical-trials data to meet the icreasig demad for these skills i the biotech ad pharmaceutical idustries. Through lectures ad labs, participats lear about various aspects of SAS programmig related to processig cliical data; uderstadig cliical-trial termiology; preparig data for submissio usig CDISC SDTM stadards, tables, listigs ad figures for electroic submissio; ad maagig regulatory cosideratios such as software-developmet life cycle ad related documetatio. Prerequisite(s): SAS for Cliical Trials for the No-Programmer, Itroductio or experiece i SAS Programmig. LINDLEY FRAHM, M.B.A. SANTA CLARA LAB WITH ONLINE MATERIALS 10 meetigs: Modays, 6 9 pm, Jauary 13 April 7 (o meetigs Ja. 20, Feb, 17 ad 1 o meetig TBA). Fee: $875. To eroll, use Sectio Number 4670.(012) Special Program Cliical Trials Essetials: A Itesive Oe-Week Course Offered i collaboratio with CACO Pharmaceutical AND BioSciece Society (CACO-PBS) NATSC.825. (35.0 CEUs) CA BRN/LVN Credit Provider #CEP13114, 35.0 hours. Well-plaed, well-executed cliical trials are the corerstoes of effective drug ad medical device developmet. Offered i a accelerated format taught by a team of biopharmaceutical idustry leaders, this course provides a uique opportuity for professioals from all disciplies to lear about the may facets of cliical trials the complex process that esures the safety ad effectiveess of medical products. Participats leave the program with a appreciatio of the drug ad device developmet process; as well as good cliical practice (GCP) ad other regulatios (ICH ad FDA) that guide the coduct of trials ad protect huma voluteers. Also covered are cliical trial phases ad desig strategies; the importace of iformed coset ad the role of the IRB; ivestigator selectio ad resposibilities; study site maagemet ad trial moitorig; statistical data aalysis; ad regulatory resposibilities ad the role of the FDA. The course beefits ayoe workig i the biopharmaceutical ad medical device idustries ad the biomedical commuity who is iterfacig with or coductig cliical research, icludig ew cliical research associates ad study coordiators; medical directors, physicias, urses, pharmacists, ad other health professioals; biomedical scietists; statisticias ad database admiistrators; ad busiess professioals. Expert Istructio Team Taught by a team of cliical research experts, icludig may from UCSC Extesio s Cliical Trials Desig ad Maagemet Certificate. 5 meetigs: Moday Friday, 8:30 am 5:30 pm, March Fee: $1865. To eroll, use Sectio Number 5433.(012) Also of Iterest Viruses, Vaccies ad Gee Therapy For course descriptio, see page 13. Copyright 2014 The Regets of the Uiversity of Califoria. All Rights Reserved. 17
20 MEDICAL DEVICES Bioscieces Medical Devices Certificate Program Medical Devices Program Cotact Applied ad Natural Scieces Departmet, (408) , or Program Summary Medical devices iclude a broad spectrum of products, from the simple togue depressor to surgically implated stets ad i-vitro diagostics. Altogether, the U.S. medical device market is estimated at approximately $100 billio. The Bay Area is home to oe of the highest cocetratios of medical device start-ups i the U.S., with a broad array of established compaies that vary i size, core techology ad therapeutic focus. There are excitig opportuities i this robust idustry for professioals from a rage of disciplies. The Medical Devices Certificate Program covers topics that are critical to the developmet ad commercializatio of safe ad effective medical devices ad i-vitro diagostics (IVDs). Takig a practical ad hads-o approach, the courses build a solid foudatio that spas product desig ad developmet, regulatory ad quality issues, iovatio strategy, risk maagemet ad more. Experieced ad aspirig medical device professioals will gai isight ito the techological, regulatory ad busiess aspects of the idustry ad lear what it takes to be successful i the dyamic ad highly regulated medical device idustry. Courses i this program will beefit professioals from a wide rage of disciplies. Audiece Those who wat to eter the expadig field of medical devices Cross-developmet teams from medical device ad IVD (i-vitro diagostics) compaies, icludig those i quality assurace (QA), regulatory, R&D, product developmet, software ad hardware egieerig, product maagemet, customer support, product verificatio ad validatio, marketig, operatios/ maufacturig ad cliical research Certificate Requiremets Total of 17 uits 11 required uits 6 elective uits For GPA requiremets ad program time limits, see page 4. To pursue two biosciece-related certificates i parallel or i sequece, see chart o page 10. Prerequisites There are o prerequisites for eterig this program, although a uderstadig of statistics is ecessary. Statistics (23588) is recommeded for studets eterig the program without prior kowledge. Recommeded Course Sequece Those ew to the field should start by takig Itroductio to Medical Device Regulatio ad Medical Device Quality Systems. After that, core courses ca be take i ay order, with the exceptio of Huma Factors ad Usability i Medical Device Developmet, which should be take after the Medical Device Quality Systems ad Risk Maagemet for Regulated Idustries courses. For those with experiece i this field, courses ca be take i ay order. Regulatio of Medical Devices ad Diagostics or Medical Devices: Regulatory Strategies ad Marketig Pathways take withi the last five years at UCSC Extesio fulfills the requiremet of Itroductio to Medical Device Regulatio. If couted toward aother certificate already, a additioal 1.5 uits of electives eed to be take. For More Iformatio Curret ad future course schedules ca be foud at ucsc-extesio.edu/bioscieces. For more iformatio o this program or to be added to our mailig list, please call (408) or cotact ucsc.edu. For Certificate Applicatio Iformatio ad Policy o Trasferrig Credit from Other Schools, see page uit miimum Medical Devices Advisory Board MEDICAL DEVICES CErtificatE JILL AMSTUTZ, Fouder, Jav Medical (Strategic Product Marketig) ANTHEA DOKIDIS, Ph.D., Seior QA Staff, Proteus Biomedical KIRAN GULATI, M.B.A., RAB-LA, Maagemet Cosultat DAVID KING, Vice-Presidet R&D, Affymetrix BILL KURANI, M.S.R.A., M.S.E.E., Pricipal, Atrix Ic. RA/QA Cosultat MICHAEL OYE, Ph.D., Director Materials Aalysis for Collaborative Sciece Facility, UCSC GEETHA RAO, Ph.D., Vice Presidet Strategy ad Risk Maagemet, Triple Rig Techologies, Ic. TOM SHOUP, Ph.D., Ex Vice Presidet, R&D Siemes, Product Developmet Cosultat PAUL STEINER, Ph.D., Associate Director, Fibroge KELLY STONE, Director of Risk Maagemet ad Surveillace, Lifesca Required Courses uits Course F W Sp Su Itroductio to Medical Device Regulatio Medical Device Quality Systems Desig Cotrol for Medical Devices Risk Maagemet for Regulated Idustries Huma Factors ad Usability i Medical Device Developmet Elective Courses (6 uits required) Uits Course F W Sp Su Mobile Medical Applicatios Medical Device Verificatio ad Validatio Product Developmet Life Cycle for Medical Devices Post-Market Regulatory Obligatios for Medical Devices Value-Added Quality Audits Medical Device Marketig Data Privacy ad Security for Healthcare ad Bioscieces Ay oe course from UCSC Extesio s Regulatory Affairs Certificate Program may be applied toward the elective uit requiremet for the Medical Devices Certificate. held i classroom m offered olie p both classroom ad olie sessios are available Visit ucsc-extesio.edu for the most curret program schedule. 18 Register olie today with just a few clicks o our Web site. Visit ucsc-extesio.edu.