Overview of Clinical Research Course - Spring 2010 Program *NEW DATE*
Thursday, March 4 2010
6:00 pm – 8:30 pm
Tuition discount for employees of MassBio Member Companies!
*Please note the date change This class will now begin on March 4!*
This 13-week program is MassBioEd's longest running program, providing a comprehensive understanding of the drug development process from drug discovery to protocol development, data management to clinical trials.
This program examines the many details that must be considered in the clinical research process, including Food and Drug Administration (FDA) regulations and corporate Standard Operating Procedures (SOPs). Students gain practical knowledge about the complex interrelationships between sponsors, contract research organizations (CROs), the FDA, site management organizations (SMOs), and investigative site staff.
Topics Covered Include:
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1. Introduction & Overview of the Business of Drug Development |
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2. Bench to Bedside: An Overview of the Regulatory Process |
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3. Clinical Trial Design & Protocol Development |
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4. Ethics in Clinical Research: Institutional Review Board Process and Informed Consent |
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5. Economics and the Patient |
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6. Introduction to Clinical Trial Management |
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7. The Research Site and Clinical Trial Start-up Activities |
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8. Patient Enrollment & Clinical Trial Monitoring |
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9. Drug Safety and Post-Marketing Surveillance: The Changing Arena of Risk Management |
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10. Data Management & Biostatistics |
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11. Overview of Medical Devices Development |
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12. Quality Systems and Clinical Trial Audits |
For more information and to register, visit: https://secure.massbioed.org/courses/index.php?page_function=detail&course_id=25.
Register Today!
MassBio Telepresence
Looking for some place to host an event? Book the MassBio Conference Room! We have recently upgraded our facilities to include full webcasting and teleconferencing functions. Connect to clients, coworkers and colleagues around the country or around the world without the expense of travel.
Download the rate card here.
For more information, please contact Jeff Ouimette at 617-674-5100 or telepresence@massbio.org.