Overview of Clinical Research Course - Spring 2011 Program
Thursday, March 31 2011
6:00 pm – 8:30 pm
Event Inquiries
Hannah Yun, MassBioEd Director of Education & Training Programs, courses@massbio.org
Tuition discount for employees of MassBio Member Companies!
COURSE DATES: THURSDAY EVENINGS Beginning March 31, 2011 (Please note date change)
This 11-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:
|
1. Introduction & Overview of the Business of Drug Development |
|
2. Bench to Bedside: An Overview of the Regulatory Process |
|
3. Clinical Trial Design & Protocol Development |
|
4. Ethics in Clinical Research: Institutional Review Board Process and Informed Consent |
|
5. Economics and the Patient |
|
6. The Research Site and Clinical Trial Start-up Activities |
|
7. Patient Enrollment & Clinical Trial Monitoring |
|
8. Drug Safety and Post-Marketing Surveillance: The Changing Arena of Risk Management |
|
9. Data Management & Biostatistics |
|
10. Overview of Medical Devices Development & 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=40
