Clinical Trials Ppt

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CLINICALTRIALS DESIGN&MANAGEMENTPROGRAMPresented by:Karen Nelson Villanueva – Program LeadLajja Shah – CEL Assistant

DISCLAIMER You will be participating in an SF State event where audio and video is beingrecorded. By participating in this event, you consent to audio recording, videorecording and its/their release, publication, exhibition, or reproduction to beused for news, web casts, promotional purposes, telecasts, advertising on websites, or for any other purpose(s) that SF State, its vendors, partners, affiliatesand/or representatives deems fit to use. You release SF State, its officers andemployees, and each and all persons involved from any liability connectedwith the taking, recording, digitizing, or publication of interviews,photographs, computer images, video and/or or sound recordings. You have been fully informed of your consent, waiver of liability, and releasebefore participating in this SF State Event.

PROGRAM OVERVIEWEver-evolving governmentregulations are putting a newfocus on clinical trials in thepharmaceuticals, biologics, andbiotechnology deviceindustries.This program helps youbecome a successful memberin clinical research operations.Ideal fit for career changersand enhancersYou will gain a foundationalunderstanding of the field toimproving your overall duals who pursue thiscertificate are professionals,often with advanced degrees,working in science, health care,technology or management

LEARNING OUTCOMESThe Clinical Trials Design & ManagementProgram Certificate prepares students tobecome clinical research associates orcoordinators.Our curriculum covers core concepts, includingregulatory affairs, biostatistics, clinical trialsdesign, data management and safetymonitoring. The sequence of courses gives youskills that biotechnology and pharmaceuticalindustry employers are looking for.

WHY ENROLL WITH US?Taught by activeprofessionalsConvenientonline programYour own pace,up to 3 years 4,790 forcertificate

COURSE REQUIREMENTSRequires access to laptopand internet connectionFamiliarity with iLearnComfortable with onlinelearning environmentWebcam & micrecommended

CERTIFICATE REQUIREMENTSCourse #Required CourseIT 9357Overview of Clinical Development1.8IT 9358IT 9387IT 9388IT 9359IT 9386IT 9531Good Clinical Practices (GCP)Clinical Trials MonitoringClinical Trials DesignClinical Data ManagementBiostatisticsIntroduction to Regulatory Affairs (US)1.81.81.81.81.81.2IT 9539IT 9351IT 9354IT 9392Safety MonitoringClinical Project Management IClinical Project Management IICase Report Form DesignORCompliance Audits/FDA Inspections1.21.81.80.6IT 9391CEU0.6Once you have completed ALLthe necessary coursework,submit the Certificate ofCompletion Request Form:https://cel.sfsu.edu/certificaterequest

GET STARTEDü All students will need an SF State ID & Password to enable registration and Payment atCollege of Extended Learning. Use Quick Admit to obtain and SFSU ID and Passwordhttps://cel.sfsu.edu/register/quickadmitü Overview of Clinical Development and Good Clinical Practices are prerequisites to all otherclasses. Please contact us directly if you have any other questions.ü To access the online class, visit http://ilearn.sfsu.edu to log in after registration andpayment using SF State ID and password.

WAYS TO REGISTERIN PERSONREGISTRATIONComplete the Registration ments/register/regform.pdfDrop off the form at MainCampus or Downtown CampusONLINERegister & pay onlinewith gatewayinstructionsONLINE – STAFF ASSISTComplete the onlineregistration form, and you willbe contact within 24 HONECall (415-405-7700)Hours: Monday – Friday,9AM-5PM. Please haveyour SFSU ID and ClassNumbers ready

FACULTYRon LillieDirector – Drug Safety DataAnalytics @ Exelixis, Inc.Siu Po SitVP – Clinical Affairs @Penumbra Inc.Tenea NelsonToxicologist @ GenentechThomas TremblaySr. Director – Clinical Operations@ a local sf companyPeter ShabePresident @ AdvanceResearch Associates, Inc.Bethany Van VeenConsultant for Bay Areapharmaceutical companiesFabio De MartinoSr. Manager – Global Quality @GenentechWajiha AliSr. CRA @ AssemblyBiosciences, IncAbigail WaiteAssociate Director @BioMarin PharmaceuticalTo learn more about each faculty and theirbackground, please visit:https://cel.sfsu.edu/clinicalonline/faculty

THANKYOUKaren Nelson Villanueva,MPA, PhDProgram Leadpronouns: she, her, hersknv@sfsu.edu(415) 817-4324

IT9358 Good Clinical Practices (GCP) 1.8 IT9387 Clinical Trials Monitoring 1.8 IT9388 Clinical Trials Design 1.8 IT9359 Clinical Data Management 1.8 IT9386 Biostatistics 1.8 IT9531 Introduction to Regulatory Affairs (US) 1.2 IT9539 Safety Monitoring 1.2 IT9351 Clinical Project Management I 1.8 IT9354 Clinical Project Management II 1.8

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