COURSES START WEEKLY UCSC-EXTENSION.EDU

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1 fall september december 2015 COURSES START WEEKLY UCSC-EXTENSION.EDU Egieerig & Techology bioscieces EdUCATION business & Maagemet

2 New courses & PROGRAMS ENGINEERING AND TECHNOLOGY Itroductio to 3D Digital Modelig with Bleder Itroductio to Apache Spark with Scala Security Iformatics 3 revised: Developig Hybrid Mobile Applicatios Usig Apache Cordova Desigig Wearable ad Smart Device User Experieces The Iteret of Thigs: System Desig ad Prototypig PROFESSIONAL AWARD Mobile Applicatio Developmet BUSINESS AND MANAGEMENT Erolled Aget Review, Part 3 Represetatio, Practices ad Procedures PROFESSIONAL AWARD Busiess Aalysis COURSE PLANNING SESSION Registratio required. Meet oe-o-oe with departmet staff to refie your plas to best suit your backgroud ad professioal iterests. ROAD CLOSURE DETOUR ROUTES Please check our website for detour iformatio as costructio progresses i our area throughout If you have t doe so already, sig up for our mailig list: ucsc-extesio.edu/ subscribe-eewsletter Follow us o social media: Facebook: ucscext LikedI: ucsc-extesio-i-silico-valley Ifo You re Ivited Sessios Joi us for free ifo sessios hosted by staff to lear about our professioal educatio programs. Reserve your seat today. August 2015 olie BUSINESS ADMINISTRATION ad M.B.A. Prerequisites Available Jue 15 August 31 Accoutig ad CPA Cliical Trials, REGULATORY Affairs ad Medical Devices Huma Resource Maagemet Moday, august 17 Fiacial Plaig Marketig Maagemet WEDNESday, august 19 Early Childhood Educatio Educatioal Therapy Istructioal Desig ad Delivery TESOL Program Thursday, august 20 Web ad Iteractive Media Desig Moday, august 24 Embedded Systems ad VLSI Egieerig Project ad Program Maagemet TUESDAY, august 25 Biotechology ad Bioiformatics Software Developmet Programs WEDNesday, August 26 Admiistrative ad Executive ASSISTANTS Iformatio TECHNOLOGY ad DATABASE ad Data ANALYTICS Thursday, august 27 olie TECHNICAL Writig ad Commuicatio Available September 21 November 20 Lear about our programs, etwork with workig professioals ad gai valuable isight from experts i your field. Sig up ow at ucsc-extesio.edu/evets.

3 Dea Lyda M. Rogers, Ed.D. UCSC Silico Valley Extesio 2505 Augustie Drive Sata Clara, CA Volume 48 Number 3 July 2015 UCSC Silico Valley Extesio (USPS ) is published four times a year (February, April, July, November) by UCSC Silico Valley Extesio, 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 Silico Valley Extesio 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 2015 The Regets of the Uiversity of Califoria All Rights Reserved. Address To cotiue receivig the course catalog, sed both your old ad ew addresses ad zip codes to: UCSC Silico Valley Extesio 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 (7/10/15) Itroducig UCSC Silico Valley Extesio: Versio 3.0 O Sicerely, ver the past 50 years, UCSC Silico Valley has offered courses from Moterey to Sata Cruz, Suyvale to Cupertio. Whe we moved to Sata Clara i 2009, we were excited to brig our programs together i the same locatio. Sata Clara has bee a good home for us; we have see sigificat icreases i erollmet ad diversified our offerigs to meet the eeds of professioals i a umber of differet idustries. The commuity has embraced us, ad we have embraced the commuity of Sata Clara. The ladscape of Sata Clara is chagig. You might have oticed some big chages takig place i recet years. First the Sa Fracisco 49ers made Sata Clara their ew home, i the beautiful Levi Stadium just dow the road from us. The the Irvie Compay bega costructio o Sata Clara Square, a ew itegrated workplace commuity a stoe s throw from our Augustie address. New busiesses are discoverig the gem that is Sata Clara, ad usherig i a reewed commitmet for iovatio ad creativity. At UCSC Silico Valley, we ecourage our studets to ivest i their futures by takig courses ad masterig emergig tools ad techologies. As the cityscape of Silico Valley grows ever taller, we re pleased to aouce that we, too, are embracig ew opportuities. I am pleased to aouce that we will be movig to a ew facility i As thrillig as it is to be swept up i the mometum of Silico Valley s fast pace, our core missio to provide high-quality, job-developmet courses for the workig professioal remais uchaged. Whe the day comes for us to leave Augustie Drive, we pla to tur off the lights i oe buildig, cross the street ad tur the lights o i our ew facility. The move will have miimal impact o courses i sessio; we ll be postig regular updates o our ew facility at ucsc-extesio.edu. We live i a era whe smartphoes ca track medical records, cars ca ru o battery power, ad every year we expect product upgrades. This year, UCSC Silico Valley is gettig a sizable upgrade. Every day we lear how our studets ad alumi are trasformig idustries with ew applicatios, discoveries ad busiesses may great ideas have origiated i our classes, break rooms ad louges. We ca t wait to see what you do i our ew space. 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) Iteratioal studet Services (408) To make chages or correctios to the mailig label, call (408) Lyda M. Rogers, Ed.D. Dea, UCSC Silico Valley Extesio Follow us o Facebook ad Twitter THE ORIGINAL AUTHORITY ON QUESTIONING AUTHORITY 1

4 Areas of Study Missio Statemet UCSC SILICON VALLEY Extesio 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 scout from Uiversity of Califoria UCSC EXTENSION ONLINE Geeral Iformatio Erollmet Drops ad Refuds Taxpayer Relief Act Academic Policies Grades Trascripts Disabled Studet Services Holidays Textbooks Tobacco-Free Policy Ope campus/ cocurret erollmet Istructor Biographies Idex Course Titles, Programs ad Evets Maps ad Directios Busiess ad Coferece Services Proctorig Services

5 Bioscieces...8 Bioscieces Bioiformatics...9 Biotechology...12 Cliical Trials Desig ad Maagemet...15 Medical Devices...17 Regulatory Affairs...19 Busiess ad Maagemet...21 Accoutig Accoutig...22 CPA Preparatio...26 Admiistrative ad Executive Assistat...27 Bookkeepig Certified Bookkeeper Program...29 Busiess Admiistratio Busiess Admiistratio...29 Graduate School Preparatio...31 Fiacial Plaig Persoal Fiacial Plaig...31 Huma Resources Huma Resource Maagemet...34 Istructioal Desig ad Delivery...36 Legal Studies Paralegal Core...37 Paralegal Advaced...37 Miimum Cotiuig Legal Credit (MCLE)...38 Marketig Marketig Maagemet...38 Project Maagemet Project ad Program Maagemet (PPM)...41 Busiess Aalysis...43 Techical Writig ad Commuicatio...45 Web Cotet Maagemet...47 FALL 2015 Educatio...48 Credetial Courses...49 Early Childhood Educatio Early Childhood Educatio...51 Early Childhood Educatio: Supervisio ad Admiistratio...53 Educatioal Therapy...54 Istructioal Desig ad Delivery...56 Teachig Eglish to Speakers of Other Laguages (TESOL)...58 Egieerig ad Techology...61 Hardware Systems ad VLSI Egieerig Embedded Systems...62 VLSI Egieerig...66 Iformatio Techology...68 Liux Programmig ad Admiistratio...71 Software Developmet Computer Programmig...73 Iteret Programmig ad Developmet...78 Mobile Applicatio Developmet...79 Software Egieerig ad Quality...80 Database ad Data Aalytics...82 Web ad Iteractive Media Desig...85 Evirometal Health ad Safety...88 Hazardous Materials Maagemet...89 Occupatioal Safety ad Health Maagemet...89 Evirometal Safety ad Health Maagemet...89 HAZWOPER...91 UCSC Extesio Olie...92 Ope Campus Dea s Letter, Table of Cotets, Iteratioal Programs Bioscieces Busiess ad Maagemet Educatio Egieerig ad Techology Evirometal Health ad Safety UCSC Extesio Olie, Ope Campus, Geeral Ifo, Istructor Bios, Idex, Maps, Erollmet Form

6 Certificate Programs FALL 2015 The Value of a UC Certificate UCSC Silico Valley Extesio 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 declarig cadidacy receive a letter grade of C or better 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 s Completio Review course ad pay a $75 fee. Oce paid, please cotact extesioprogram@ ucsc.edu 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 website at ucsc-extesio.edu/ forms, ad sed your request alog with a course outlie, descriptio ad trascript 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 Techical Writig ad Commuicatio Web Cotet Maagemet Educatio Early Childhood Educatio Early Childhood Educatio: Supervisio ad Admiistratio Educatioal Therapy Istructioal Desig ad Delivery 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 Silico Valley Extesio 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 website (admissio.uiversityofcaliforia.edu) 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 website. 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. Most textbooks ca be purchased through Extesio s partership with Amazo.com. Our website has a coveiet search tool olie at ucsc-extesio.edu/bookstore. Tuitio Assistace Displaced or disadvataged workers may be eligible for federal assistace through the Workforce Ivest met 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 extesiowib@ucsc.edu. 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. Eroll i Courses at No Cost to You! May of UCSC Extesio s courses may qualify for corporate tuitio reimbursemet. Fid out if your employer offers tuitio reimbursemet. TAXPAYER Relief Act of 1997 The Taxpayer Relief Act of 1997 may help you put moey back i your pocket. Cotact a tax cosultat or accoutat or visit to determie how the Act may apply to you. The Uiversity is required by federal law to request Social Security umbers from all erolled studets who may qualify for tax credits. See page 95 for more iformatio. 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 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 92. 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 ear Great America i Sata Clara. See page 107 for maps to our campus. 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) 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. Details o our gradig policy are foud o page 96. 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. It s easy to Eroll Olie: Visit our website 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. Obtai a studet visa Lear busiess ad techology skills durig your time i the U.S. Become eligible for oe year of work authorizatio via Optioal Practical Traiig (OPT) after completig your program UCSC Extesio s professioal certificate programs are located i the heart of Silico Valley. The Valley is the world ceter of cuttigedge 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. Most 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 You with the Visa Process Oce you have applied ad bee accepted, UCSC Extesio will issue you a I-20, which ca be used for iitial etry, trasfer, chage of status or 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 apply your high-quality educatio with a year of work experiece i the U.S. Go to ucsc-extesio.edu/ iteratioal-program/practical-traiig for details. 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: Computer Programmig sprig SUMMER April 1 Jue 15 Jue 16 August 31 March 15 May 15 February 15 May 1 Database ad Data Aalytics Software Egieerig FALL September 1 December 31 August 15 July 15 Project ad Program Maagemet Marketig Huma Resources Biotechology TESOL 6

9 FALL 2015 Admissio Requiremets Uiversity diploma or equivalet Eglish Proficiecy Score (TOEFL 80 IBT, IELTS 6.5, TOEIC 760) or equivalet Bak statemet (miimum $25,000*) Copy of passport Copy of visa (if applyig i U.S.) Electroic I-94 (if applyig i U.S.) Copy of I-20 (if trasferrig) * $25,000 covers both tuitio ad livig expeses for oe academic year. How to Apply Details o how to apply ca be foud o our website at ucsc-extesio.edu/iteratioal. Most studets begi by settig up a meetig with oe of our iteratioal studet advisors. Cotact us at: extesioiteratioal@ucsc.edu (408) Ray Porras Iteratioal Program Assistat Kathy Harrigto Iteratioal Studet Advisor, OPT Specialist Diae Johase Iteratioal Studet Advisor, Itership Coordiator Michael Mrache Iteratioal Programs Maager Iterships As a iteratioal studet erolled i a certificate program, you are eligible to eroll i a upaid itership i your field of study ad have two optios: 1. Arrage your ow itership ad register for the itership course for $ Cosult with the Itership Coordiator, who will provide outreach ad support i securig a itership. There is a additioal $250 fee for this service which must be paid i advace. For details, the Itership Coordiator at extesioiteratioal@ucsc.edu or call at (408) You ca ear a maximum of 3 uits each quarter for a upaid itership by erollig i our itership course, Busiess Practices for Iteratioal Studets. To receive 3 uits you must voluteer a miimum of 90 hours durig the quarter. WHAT our StudetS SAY: MILI GOPAL Web Desig ad Developmet studet Jua Escobedo Embedded Systems studet This is a great step i my career; it s a dream come true, to thik that I joied ebay so soo after fiishig my program. Jayakumar Guaskar Iteret Programmig ad Developmet studet The upaid itership was really helpful; it helped me gai experiece i Silico Valley ad get a job with my desired role whe I was o OPT. I always wated to work i Silico Valley all the ivetios are developed here. The courses offered skills that I wated to lear, like how to program FPGAs ad ASICs. 7

10 Bioscieces Fall 2015 WHAT StudetS SAY ALEXANDRA STEINBERG Cliical Trials Desig ad Maagemet Whe Alexadra Steiberg moved to Califoria from Russia, she was a practicig doctor with both a M.D. ad a Ph.D., ad she wated to trasitio ito cliical trials. She erolled i UCSC Extesio s Cliical Trials program ad i less tha two years, had completed the certificate ad started workig as the medical director of a Bay Area pharmaceutical compay. Full Picture of Cliical Trials Back i Russia, I developed my medical ad scietific expertise, she says. Takig classes, I leared everythig about coductig cliical trials i U.S. as well as iteratioally, icludig regulatory requiremets, moitorig, safety reportig, etc. Whe I started my career i the U.S., the classes completed the whole puzzle for me, combiig my medical kowledge ad Ph.D. experiece with the operatioal ad regulatory sides of coductig cliical trials i the pharmaceutical idustry. Real-World Applicatios Steiberg says that she still uses the kowledge leared at Extesio. My resposibilities are to desig cliical studies, perform medical moitorig durig the study coduct, be resposible for safety of the subjects (from the sposor perspective), provide medical support to the study team, review the data, ad so o, she says. I m usig the kowledge I leared i my studies ad gettig experiece o top of it, which make me feel satisfied with my career. It s very creative work ad I ejoy it every sigle day. 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 extesiofeedback@ucsc.edu. Whe I started my career i the U.S., Extesio s classes completed the whole puzzle for me. 8 Visit our website at ucsc-extesio.edu for updated iformatio ad to eroll olie.

11 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 11. 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 extesioprogram@ucsc.edu. For Certificate Applicatio Iformatio ad Policy o Trasferrig Credit from Other Schools, see page 4. Program Chair Bioiformatics ad Biotechology JIM SCHWEPPE, M.A., Ph.D., was a postdoctoral scholar at UC Sata Cruz i the Departmet of Chemistry ad Biochemistry with a joit affiliatio with the Ceter for Molecular Biology of RNA. His research expertise icludes biological chemistry, structural biology, molecular biology, ad immuology. Dr. Schweppe eared his B.S. i biochemistry from Marlboro College i Vermot, ad completed his M.A. ad Ph.D. degrees i chemistry at Bry Mawr College i Pesylvaia. Prerequisite Courses Molecular Biology, Itroductio NATSC.X425.9 (3.0 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 30.0 hours. This course itroduces molecular biology for o-biologists ad offers a review for those who wat a update. 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 reviews experimetal methods used i molecular biology, such as recombiat DNA, PCR, gee cloig, ad gee expressio aalysis. Prerequisite(s): College-level biology is recommeded. GUIDO BORDIGNON, Ph.D., M.S. 9 meetigs: Tuesdays, 6 9:30 pm, October 13 December 15 (o meetig Nov. 24). Fee: $675. To eroll, use Sectio Number 4213.(086) bioscieces IN THIS SECTION Bioscieces Bioiformatics w Bioiformatics 9 w Biotechology 12 w Cliical Trials Desig ad Maagemet 15 w Medical Devices 17 w Regulatory Affairs 19 Bioscieces UCSC Extesio s biosciece courses ad programs address 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 biosciece 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 Silico Valley Extesio ca help you succeed. FEATURED FALL COURSES Biomedical Ethics Desig Cotrol for Medical Devices Drug Safety ad Adverse Evets Reportig Next Geeratio DNA Sequecig: Methods ad Applicatios Viruses, Vaccies ad Gee Therapy Copyright 2015 The Regets of the Uiversity of Califoria. All Rights Reserved. 9

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13 Bioscieces Bioiformatics 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 m m m Statistical Aalysis ad Modelig for Bioiformatics ad Biomedical Applicatios Elective COURSES (7 uits required) Uits Course F W Sp Su Take required courses before electives. Biomedical Ethics m m Computatioal Biology with Java DNA Microarrays: Priciples, Applicatios ad Data Aalysis m m Drug Discovery, Itroductio Gee Expressio ad Pathways Next Geeratio DNA Sequecig: Methods ad Applicatios 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 s hybrid p both classroom ad olie sessios are available Lear More for Less Visit ucsc-extesio.edu for the most curret program schedule. 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 extesioprogram@ 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 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. ROBERT KNIGHT, M.S., D.P.M. ONLINE, September 8 December 17. Erollmet accepted through October 30. Fee: $860. To eroll, use Sectio Number (017) 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. 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 algorithm developmet ad advaced computatioal methods. You ll lear through computer lab exercises ad olie demostratios of databases ad Web-based tools. This is the recommeded first course for those watig to gai bioiformatics skills. Prerequisite(s): Molecular Biology, Itroductio. LEE KOZAR, M.A., M.S., M.B.A. SANTA CLARA LAB WITH ONLINE MATERIALS 10 meetigs: Modays, 6 9 pm, September 28 December 14 (2 o meetigs TBA). Fee: $765. To eroll, use Sectio Number 2447.(055) Register Early! Eroll at least seve days prior to your course s start date to save your seat ad allow time to prepare for the first class meetig. Registerig early also helps esure that your course is ot cacelled due to low erollmet. Copyright 2015 The Regets of the Uiversity of Califoria. All Rights Reserved. 11

14 Bioiformatics / Biotechology Bioscieces 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 Wedesdays, 6 8:30 pm, August 26. No fee, but registratio required. To eroll, use Sectio Number (021) 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. You ll also lear about high-throughput sequecig ad microarray expressio aalysis ad the types of data these techiques geerate. Prerequisite(s): Molecular Biology, Itroductio. GUIDO BORDIGNON, Ph.D., M.S. ONLINE, September 8 December 17. Erollmet accepted through October 30. Fee: $765. To eroll, use Sectio Number 1912.(047) Statistical Aalysis ad Modelig for Bioiformatics ad Biomedical Applicatios CMPS.X445.1 (3.0 quarter uits) This course presets the statistical methods most frequetly used i bioiformatics ad biomedical research. Topics iclude probability, statistics, hypothesis testig, cofidet itervals, t-tests, aalysis of variace, regressio aalysis, stochastic processes, Markov chais ad hidde Markov models, pairwise aligmet usig HMMs, Weka, ad Broad ad Bayesia approaches. You ll gai experiece performig statistical aalyses usig the R programmig laguage. Examples are draw from biomedical applicatios, such as gee expressio aalysis, molecular diagostics, ad evaluatio of ew drugs ad medical devices. Kowledge of calculus is recommeded but ot required. Prerequisite(s): Statistics. Fee: $765. To eroll, use Sectio Number 1032.(046) Elective Courses Biomedical Ethics For course descriptio, see page 19. DNA Microarrays: Priciples, Applicatios ad Data Aalysis For course descriptio, see page 14. Drug Discovery, Itroductio For course descriptio, see page 13. 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 study of gee expressio pathways i simple cells (prokaryotes) ad complex multicellular orgaisms. You will lear about abormalities i gee expressio pathways ad how they relate to huma diseases, icludig viral, immue ad metabolic diseases, as well as cacer. The course also discusses methods used to maipulate, moitor ad aalyze gee expressio levels i cells ad whole orgaisms, ad the relevace of these techiques to research, drug discovery ad diagostic medicie. Prerequisite(s): Molecular Biology, Itroductio. Prior molecular biology course work or backgroud is strogly recommeded. LAMIA WAHBA, Ph.D. SANTA CLARA CLASSROOM AND ONLINE (HYBRID) 6 meetigs: Fridays, 6 9:30 pm, October 9 November 13. Fee: $715. To eroll, use Sectio Number 6020.(026) Next Geeratio DNA Sequecig: Methods ad Applicatios For course descriptio, see page 14. Biotechology Certificate Program Biotechology Certificate Cotact Applied ad Natural Scieces Departmet, (408) , or extesioprogram@ucsc.edu. 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 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 cuttigedge 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 11. 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 extesioprogram@ucsc.edu. 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 extesioprogram@ucsc.edu. 12 Visit our website at ucsc-extesio.edu for updated iformatio ad to eroll olie.

15 Bioscieces Biotechology 19-uit miimum BIOTEchology 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 m m m Experimetal Methods i Molecular Biology m m m 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 Next Geeratio DNA Sequecig: Methods ad Applicatios Stem Cell Biology Toxicology Basics for Biotechology m m m m Viruses, Vaccies ad Gee Therapy Track 2: Developmet Biomedical Ethics m m 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 Regulatio of Drugs ad Biologics Statistical Desig of Experimets: A Practical Approach Recommeded COURSE Uits Course F W Sp Su Biotechology Basics for No-Scietists 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 s hybrid p both classroom ad olie sessios are available Visit ucsc-extesio.edu for the most curret program schedule. Medical ad Health Career Preparatio Cosiderig a career i medicie? Medical schools recommed that applicats study advaced topics i bioscieces as they relate to health ad disease. At UCSC Extesio, we offer a variety of courses that fulfill the suggested electives for medical, detal, ad veteriary colleges. Cotact extesiobiosciece@ucsc.edu for more iformatio. 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. This course examies this process from discovery to market ad beyod ad explores 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 pharmacological ad cliical developmet; regulatory filigs, compliace ad oversight; FDA jurisdictio; ad strategic issues i drug developmet. The course provides a foudatio i drug developmet for professioals from all disciplies who work i, or are cosiderig a move to, the biopharmaceutical idustry. EDWARD ROZHON, Ph.D. 10 meetigs: Thursdays, 6 9 pm, October 1 December 10; Saturdays, 9 am 4 pm, December 12 (o meetig Nov. 26 ad 2 o meetigs TBA). Fee: $765. To eroll, use Sectio Number 6559.(053) Drug Discovery, Itroductio NATSC.X427.7 (3.0 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 30.0 hours. This itroductory course provides a framework for uderstadig the process of drug discovery, from target selectio ad validatio to lead optimizatio ad precliical studies. The istructor will address fudametal ad traslatioal priciples ad cuttig-edge approaches to the tools, techologies ad methods used i discovery ad developmet, alog with strategies for itegratig curret scietific approaches ito the drug discovery process. You will gai a uderstadig of pharmacokietics, pharmacodyamics, toxicology ad persoalized medicie i drug discovery, icludig the OMICS techologies, biomarkers ad sigle ucleotide polymorphism aalysis i patiet diagosis, stratificatio ad moitorig. Prerequisite(s): Molecular Biology, Itroductio. HANADIE YOUSEF, Ph.D. 9 meetigs: Tuesdays, 6 9:30 pm, October 13 December 8. Fee: $765. To eroll, use Sectio Number 4853.(032) Copyright 2015 The Regets of the Uiversity of Califoria. All Rights Reserved. 13

16 Biotechology Bioscieces Required Courses Core B Biochemistry: A Itroductio NATSC.X426.1 (3.0 quarter uits) This course covers biochemistry cocepts cetral to the biotechology idustry with a emphasis o the ezymatic ad metabolic processes of livig systems at the molecular level. Topics iclude the structure ad fuctio of biomolecules icludig proteis, carbohydrates, lipids ad ucleic acids; ezymes ad ezyme kietics; ad metabolism, icludig eergy productio ad storage. The course is beeficial for scietists ad o-scietists iterested i the critical biochemistry processes uderlyig core techologies i the pharmaceutical, medical devices, diagostics, biotechology ad biofuel idustries. Prerequisite(s): A college-level chemistry course. Some kowledge of orgaic chemistry is required. GAIL KATSIR, Ph.D. 9 meetigs: Wedesdays, 6 9:30 pm, September 30 December 16 (o meetig Nov. 11, 25 ad 1 o meetig TBA). Fee: $765. To eroll, use Sectio Number 0022.(014) Cellular Biology NATSC.X428.1 (3.0 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 30.0 hours. Essetial to ay uderstadig of biology ad its practical applicatios is a appreciatio of the structures, fuctios ad complex biological processes at work i the cell. This course covers the essetial cocepts of cellular biology, icludig the fuctios of cellular macromolecules, subcellular orgaizatio, uclear cotrol of cellular activity, cytoskeleto, cell sigalig, cacer ad more. You ll also lear the experimetal approaches used to explore cellular activities. Prerequisite(s): Molecular Biology, Itroductio. JUAN JOSÉ FUNG, Ph.D. ONLINE, September 8 December 17. Erollmet accepted through October 30. Fee: $765. To eroll, use Sectio Number 3383.(027) Experimetal Methods i Molecular Biology For course descriptio, see page 12. 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. extesiobiosciece@ucsc.edu to develop a persoalized study pla. Elective Courses Track 1: Discovery DNA Microarrays: Priciples, Applicatios ad Data Aalysis NATSC.X429.6 (3.0 quarter uits) DNA microarrays have revolutioized molecular biology ad are chagig the face of discovery research ad medicie. This course addresses the uderlyig priciples ad applicatios of the latest DNA microarray techologies, as well as the aalysis of microarray data. It is iteded for biopharmaceutical professioals, statisticias, computer scietists ad others who are iterested i uderstadig this importat techology. Prerequisite(s): Molecular Biology, Itroductio. JANANI RANGARAJAN, M.S. ONLINE, September 8 December 17. Erollmet accepted through October 30. Fee: $765. To eroll, use Sectio Number 2183.(019) Gee Expressio ad Pathways For course descriptio, see page 12. 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 isight ito emergig ad established therapies used to treat a rage of disease processes. Desiged for idividuals who have o formal medical traiig, the course itroduces the hierarchical orgaizatio of the body, from cells to coordiated orga systems, ad discusses 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. GREGORY FRANK, Ph.D. 12 meetigs: Thursdays, 6 9 pm, September 10 December 17 (o meetig Nov. 26 ad 2 o meetigs TBA). Fee: $765. To eroll, use Sectio Number 6999.(018) Next Geeratio DNA Sequecig: Methods ad Applicatios NATSC.X (3.0 quarter uits) Next Geeratio DNA Sequecig (NGS) has made it possible to sequece a huma geome at a icredibly low cost, vastly expadig the potetial applicatios of geomics i cacer diagostics, pathoge idetificatio, foresic huma idetificatio ad geetic disease diagosis. This course begis with the basics of this revolutioary process ad the delves ito specific applicatios of NGS i research ad cliical settigs. The course covers the primary methods used for highly parallel sequecig. You will develop the kowledge eeded to perform aalyses from sample prep to geeratig the fial data. Prerequisite(s): Molecular Biology, Itroductio. Completio of Bioiformatics Tools, Databases ad Methods or Experimetal Methods i Molecular Biology is recommeded. ABIZAR LAKDAWALLA, Ph.D. 4 meetigs: Saturdays, 8:30 am 5 pm, October 3 31 (1 o meetig TBA). Fee: $765. To eroll, use Sectio Number (002) 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, doserespose 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, September 8 December 17. Erollmet accepted through October 30. Fee: $580. To eroll, use Sectio Number 2310.(023) Viruses, Vaccies ad Gee Therapy NATSC.X (1.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 15.0 hours. The impact of viruses o our lives has ever bee more evidet, with outbreaks makig headlies worldwide. This course uses case studies to examie survival strategies employed by viruses, as well as ativiral drug developmet ad other implicatios for the biopharmaceutical idustry. You ll lear saliet topics i vaccies, gee therapy ad therapeutic viruses, icludig virus evolutio, emergig viruses, the risks ad beefits of vaccies, the polio eradicatio campaig, the epidemiology of iflueza, HIV-1 vaccies, ad the trials ad tribulatios of gee therapy. This course beefits both cliical ad idustry professioals. EDWARD ROZHON, Ph.D. 5 meetigs: Tuesdays, 6 9 pm, September 1 October 6 (1 o meetig TBA). Fee: $580. To eroll, use Sectio Number 6974.(014) Elective Courses Track 2: Developmet Biomedical Ethics For course descriptio, see page 19. Regulatio of Drugs ad Biologics For course descriptio, see page Visit our website at ucsc-extesio.edu for updated iformatio ad to eroll olie.

17 Cliical Trials Bioscieces Cliical Trials Ifo SeSSio 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 11. 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 extesioprogram@ucsc.edu. For Certificate Applicatio Iformatio ad Policy o Trasferrig Credit from Other Schools, see page 4. Program Chair MICHAEL HUSTON, M.B.A., B.S., presidet of Husto Associates, LLC, has 30 years of experiece i developmet, from basic research to strategic drug developmet. He has directed project teams through precliical evaluatios, Phase 1-3 cliical studies, ad four ew drug applicatios, two abbreviated ew drug applicatios ad two biologic licese applicatios. He curretly cosults for iterdiscipliary programs i drug developmet. Mr. Husto has taught for UCSC Extesio sice 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, September 12. Fee: $325. To eroll, use Sectio Number 2928.(072) Recommeded Prerequisite Course Huma Physiology i Health ad Disease For course descriptio, see page 14. 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 Moday, 6 8:30 pm, August 17. No fee, but registratio required. To eroll, use Sectio Number (021) 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 website 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). Regulatory Affairs Professioal Society 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 at for details. View complete course schedules olie at ucsc-extesio.edu Copyright 2015 The Regets of the Uiversity of Califoria. All Rights Reserved. 15

18 Cliical Trials Bioscieces 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 (13 uits) 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 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 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 STANFORD 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 extesiobiosciece@ucsc.edu. Visit ucsc-extesio.edu for the most curret program schedule. Required Courses 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, October 16, 23; Saturdays, 9 am 5 pm, October 17, 24. Fee: $750. To eroll, use Sectio Number 0608.(057) Drug Developmet Process For course descriptio, see page 13. Good Cliical Practices NATSC.X424.1 (3.0 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 30.0 hours. Cliical research is govered by a set of broad regulatory requiremets, idustry stadards ad recommedatios. Iterpretig ad implemetig these best practice stadards presets a challege for all the stakeholders ivolved i huma research. This course explores the framework ad priciples of Good Cliical Practice (GCP) as it relates to the roles ad resposibilities of various stakeholders like the FDA, Ivestigator, Sposor, IRB ad the study subject. Through lectures, homework, quizzes ad the fial exam, you will gai kowledge of regulatios (federal, state ad local) ad lear to apply the priciples of GCP. NARINDER SINGH, Pharm.D., M.B.A. 9 meetigs: Wedesdays, 6 9:30 pm, October 7 December 16 (o meetigs Nov. 11 ad 25). Fee: $800. To eroll, use Sectio Number 0458.(052) 16 Visit our website at ucsc-extesio.edu for updated iformatio ad to eroll olie.

19 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 for the electroic trasmissio of adverse evet reportig, both i pre- ad postmarketig ad i the codig of cliical trial data. This course itroduces how adverse evets ad medicatio terms are coded ad how commercial codig browsers are used. You ll gai 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 iterested i the biopharmaceutical idustry. Prerequisite(s): Medical/Cliical Termiology. Fee: $825. To eroll, use Sectio Number (020) 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. Prerequisite(s): Good Cliical Practice or Good Maufacturig Practice ad Drug Developmet Process. A basic uderstadig of huma subjects protectio i cliical research is preferred. ROSH (KAKUBHAI) VORA, M.S., Ph.D., CCRP. 7 meetigs: Thursdays, 6 9 pm, October 1 December 3 (o meetig Nov. 26 ad 2 o meetigs TBA). Fee: $750. To eroll, use Sectio Number 2315.(023) Cliical Research: The Study Site Perspective NATSC.X (1.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 15.0 hours. This course covers the cliical research process from the viewpoit of the study site. Lectures ad exercises explore the roles, resposibilities, iteractios, ad cocers of study site persoel ad highlights importat differeces betwee cliical study sites ad idustry sposors. 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 help you uderstad the study site s role i cliical research. Prerequisite(s): Good Cliical Practices. JESSICA STURM, RN, M.P.H. ONLINE, September 8 December 17. Erollmet accepted through October 30. Fee: $580. To eroll, use Sectio Number (021) Drug Safety ad Adverse Evets Reportig NATSC.X427.2 (1.5 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 15.0 hours. This course itroduces fudametal cocepts essetial to drug safety ad adverse evet reportig ad how to apply them to situatios ecoutered durig cliical trials ad post-marketig reportig. You ll lear why safety reportig is crucial; the defiitios of a adverse evet ad the key reportig issues of seriousess, expectedess, ad relatioship to the study drug. The course icludes a brief overview of reportig requiremets i the U.S. ad abroad ad the documets associated with these reports. The cotet is appropriate for CRAs, CRCs, drug safety associates, ad regulatory affairs persoel. Prerequisite(s): Good Cliical Practices ad Medical/Cliical Termiology. NARINDER SINGH, Pharm.D., M.B.A. 2 meetigs: Saturdays, 8:30 am 5 pm, November 7, 14. Fee: $580. To eroll, use Sectio Number 3990.(023) Medical Writig BUSAD.X493.5 (2.0 quarter uits) CA BRN/LVN Credit Provider #CEP13114, 21.0 hours. Biopharmaceutical compaies must produce scietific reports ad summary documets for regulatory agecies that are scietifically soud, clear, effective, ad cocise. This hads-o course builds the skills eeded to write effective documets for the biosciece idustry. Topics iclude a review good writig essetials, icludig the correct use of grammar ad puctuatio; draftig userfriedly documets that comply with global regulatios; ad creatig clear ad cocise cotet. You ll gai practice through exercises ad projects based o documetatio used i pharmaceutical developmet. The course will help you streamlie the writig process from raw ideas to fiished documets. DAVID WEST, D. H. Sc., M.P.H. SANTA CLARA CLASSROOM AND ONLINE (HYBRID) HYBRID: Classroom sessios o September 18, October 9, 30 ad November 20. Fee: $750. To eroll, use Sectio Number 4451.(017) Also of Iterest Viruses, Vaccies ad Gee Therapy For course descriptio, see page 14. Bioscieces Cliical Trials / MEDICAL DEVICES Medical Devices Certificate Program Medical Devices Program Cotact Applied ad Natural Scieces Departmet, (408) , or extesioprogram@ucsc.edu. 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 11. 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 Medical Device Quality Systems followed by Itroductio to Medical Device Regulatio. 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. Copyright 2015 The Regets of the Uiversity of Califoria. All Rights Reserved. 17

20 MEDICAL DEVICES Bioscieces Program Chair Medical Devices ad Regulatory Affairs MEDICAL DEVICES CERTIFICATE 17-uit miimum 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 KIRAN GULATI, RAB-LA, M.B.A., is a maagemet cosultat with more tha 20 years of experiece i quality systems ad process improvemet for the medical device ad biotech sectors. She has taught for UCSC Extesio sice Ms. Gulati has held positios at Geetech ad McGha Medical (formerly Collage Corporatio), where she maaged the auditig ad quality system traiig fuctios. Ms. Gulati has extesive experiece desigig ad presetig traiig for compaies i domestic as well as iteratioal settigs. Sice 2001, she has helped a large umber of medical device startups ad established compaies achieve successful results durig ISO 13485, CE Mark assessmets ad FDA audits. Ms. Gulati serves o the advisory board for UCSC Extesio s Medical Devices ad Regulatory Affairs Certificate programs. I additio, she has bee a speaker at cofereces sposored by the Istitute of Validatio Techology (IVT) ad the ASQ Silico Valley Divisio. Ms. Gulati served as the RAPS Sa Fracisco/Bay Area Chair from 2011 to 2014 ad is curretly o the RAPS North America Advisory Board. Medical Devices Advisory Board DOUG ALLEAVITCH, M.B.A., M.S., Vice Presidet of Quality ad Operatio, Nevro PEPE DAVIS, Ph.D., Vice Presidet of Busiess Process Excellece, Carl Zeiss Meditec, Ic. STEVE GEERDES, CQA, Director of Regulatory Affairs ad Quality Assurace, Zoare KRISTEN GRUMET, B.A., Executive Director, NSF Healthcare KIRAN GULATI, M.B.A., RAB-LA, Maagemet Cosultat ad Program Chair, UCSC Extesio s Medical Devices ad Regulatory Affairs Certificate Program CONNIE HOY, B.A., Seior Vice Presidet of Regulatory Affairs ad Quality, Cyosure, Ic. RON KORONKOWSKI, Director, Quality ad Regulatory, Vetio Medical Desig ad Developmet DIANA LANE, B.A., Director of Quality Assurace ad Regulatory Affairs, Natera Elective COURSES (6 uits required) Uits Course F W Sp Su Biomedical Ethics m m Global Medical Device Submissios ad Strategy Medical Device Marketig Mobile Medical Applicatios Medical Device Verificatio ad Validatio Post-Market Regulatory Obligatios for Medical Devices Value-Added Quality Audits Data Privacy ad Security for Healthcare ad Bioscieces Validatig Software for Medical Devices ad Emergig Techologies 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 s hybrid p both classroom ad olie sessios are available Required Courses Desig Cotrol for Medical Devices ENGR.X (2.0 quarter uits) This course provides isight ito the egieerig value of desig cotrol throughout the medical device lifecycle as it pertais to product quality. You ll lear the ie desig cotrol elemets eeded to clarify desig objectives, test products, ad satisfy customer requiremets, thereby shorteig the path to product ad busiess success. The course highlights the practical implemetatio of the desig history file, reviews ad records, trasfer plaig, requiremets egieerig ad project plaig. Desig verificatio ad validatio testig topics such as process validatio, biocompatibility, shelf-life, sterilizatio ad packagig validatio are also briefly covered. Prerequisite(s): Medical Device Quality Systems or Regulatory Compliace for Medical Devices or a workig kowledge of quality systems. FARHAN SHAHAB, M.B.A. SANTA CLARA CLASSROOM AND ONLINE (HYBRID) 4 meetigs: Saturdays, 10 am 2 pm, September 19, October 3, 10, 24, 31 (1 o meetig TBA). Fee: $800. To eroll, use Sectio Number (010) Visit ucsc-extesio.edu for the most curret program schedule. Medical Device Quality Systems NATSC.X (2.5 quarter uits) This course emphasizes usig the priciples of the medical device quality system (QS) regulatios ad ISO as tools to take a process-orieted, risk-based approach to compliace, while achievig strategic busiess objectives i today s regulatory eviromet. You will lear about key processes i the quality system medical device regulatio (21 CFR 820 ad ISO 13485), while addressig ocompliace challeges from a practical stadpoit. The course covers implemetatio of a effective CAPA system ad usig it as a improvemet tool, as well as idustry treds, FDA iitiatives ad best practices for iteractig with regulatory agecies. KIRAN GULATI, RAB-LA, M.B.A. 7 meetigs: Tuesdays, 6:15 9:45 pm, September 8 October 27 (1 o meetig TBA). Fee: $800. To eroll, use Sectio Number (020) 18 Visit our website at ucsc-extesio.edu for updated iformatio ad to eroll olie.