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SUCCESS
PROFESSIONAL DEVELOPMENTUniversity Extended EducationCalifornia State University, Fullerton
www.fullerton.edu/cllinicaltrials7687 7/13
Register today at www.fullerton.edu/clinicaltrials or 657.278.2611For more information, contact Amanda Lopez: 657.278.5836, [email protected]
University Extended Education
Certificate in
CliniCal Trials ProjeCT ManageMenT
Online project management courses focused on human clinical trialsThe Clinical Trials Project Management Online Courses are graduate level academic credit courses that will be offered in a cohort-based format. Each course consists of 3 units of credit; university approval is currently pending for all four courses to become the Certificate Program in Clinical Trials Project Management.
The courses are designed to meet the high demand for project management personnel for human clinical trials involving medical devices, in vitro diagnostics, biologics, pharmaceuticals, cosmetics, dietary supplements, and combination products. The focus is on managing biomedical product development for FDA and global regulatory (e.g. EU, Japan, Latin America, Canada, and Australia) approval.
The courses are ideal for professionals interested in pursuing a clinical development career. They are designed to help clinical research associates, health care and allied health professionals and professionals involved in the development of a medical product to refine their skills and expand their knowledge. The online format allows for a more flexible schedule for those already in the workforce. Even though the courses take place outside of the traditional classroom, they offer real-world experiences involving team projects and case studies.
The four courses incorporate several overall themes: project management, ethics in biomedical product development, data management and global regulatory affairs.
RequirementsStudents must have successfully completed an undergraduate degree; it is preferred that students have a Bachelor’s degree in science or a healthcare related field. Students must maintain a GPA average of 3.0 or above throughout all course work.
Benefitsn Learn the process for managing biomedical product
development for FDA and global regulatory approval
n Gain an in-depth understanding of the clinical trials process, how clinical data is used in regulatory submissions, and how clinical data is used in product labeling through a modular, operations-focus approach
n Acquire project management skills needed to successfully manage human clinical trials
n Gain a global perspective on clinical trials management to better respond to the growing industry across the globe
n Learn how to respond to ethical issues inherent in clinical trials
n Discover how to use statistical methods to monitor clinical trial outcomes and make decisions
n Gain practical knowledge through real-world case studies and team projects in product development
n Learn from instructors with industry expertise in clinical trials management
ScheduleAll courses are asynchronous online:Course 1: BIOL 535: June 10 - August 12 (summer 2013)Course 2: BIOL 537: September 16 - November 22 (fall 2013)Course 3: BIOL 538: January 20 – March 23 (winter 2014)Course 4: BIOL 539: April 7 – June 13 (spring 2014)
CostEach course will be $495 per unit, which totals $1,485 per course.
RegistrationSee www.fullerton.edu/clinicaltrials for registration instructions.Registering in these courses does not guarantee admission to either a CSUF or other graduate programs. Credits earned may be applied toward a master’s degree, depending upon program approval.
SUCCESS
THE CLASSES
Clinical Trials Project Management: Regulatory Requirements for Medical Products - BIOL 535 (3 units)
An overview of:
•RegulatoryrequirementsintheU.S.,EU,Japan,LatinAmerica, Canada, and Australia for drugs, biologics, in vitro diagnostics, devices, combination products, dietary supplements and cosmetic products
•FoodandDrugAdministration’s(FDA)organization,structure and history
•Medicalproductdevelopmentprocess:GoodLaboratoryPractices (GLP)
•GoodClinicalPractices(GCP)–standardsandregulations,pre-market and post-market
•Requirementsandbestpracticesforpostmarketclinicaltrials
•Ethicalconcernsandexaminationoftheroleofstatisticsinclinical studies
•GoodManufacturingPractices(GMPs)
•Import/ExportRegulations
•FDAAdvertising,Promotion,andLabelingRegulations
Clinical Trials Project Management: Setting Up Clinical Trials - BIOL 537 (3 units)
A comprehensive overview of:
•Typesandphasesofclinicaltrials
•ImplementationofGoodClinicalPractices(GCP)
•Developmentofclinicalstudydocuments
•InteractionswithInstitutionalReviewBoard(IRB)
•Identificationandqualificationofstudysites
•Insurancerequirementsandneeds
•Statisticalconsiderationsinstudydesign
•Ethicalissues
•Settingupclinicaltrialsglobally
•Investigatorandsubjectmatterrecruitmentissues
•Inclusionandexclusioncriteria
•Projectmanagementskillsandbestpractices
Clinical Trials Project Management: Managing Clinical Trials - BIOL 538 (3 units)
A comprehensive overview of project management issues such as:
•Successfulmanagement,monitoringandclosureofhumanclinical trials
•Preparingforandmanagingregulatoryagencyaudits
•Balancingbusinessgoalswithethicalissues
•Managingregulatoryandstatisticalissuesrelatedtodatamanagement
•Monitoringbestpractices,fromaglobalperspective
•Maintainingabudgetandscheduletomeetbusinessgoals
•Crisismanagementandconflictresolution
Clinical Trials Project Management: Pre-Market Submission Process - BIOL 539 (3 units)
A comprehensive overview of the report process for pre-market submission to the FDA, such as:
•Developmentoftimelinesforsubmissions
•ProjectmanagementprinciplesfollowedbyClinicalandRegulatory Affairs professionals employed in the biomedical industry
•Incorporationofclinicaldataintoproductlabeling
•Bestpracticesfornegotiatingwithregulatoryagencies
•ManagingPre-ApprovalInspectionsandtheroleofClinicalAffairs during these inspections
•Ethicalconsiderations
•Statisticalissuesinsubmissions
•Post-marketclinicalstudyscenarios.
•Globalsubmissions
Certificate in
CliniCal Trials ProjeCT ManageMenT
www.fullerton.edu/cllinicaltrials
Register today at www.fullerton.edu/clinicaltrials or 657.278.2611For more information, contact Amanda Lopez: 657.278.5836, [email protected]
University Extended Education
