|
|
 |
|
|
Questions Every Investigator Should Ask BEFORE Doing Research with Drugs, Devices, & Biologics
|
EVENT DATE & TIME November 5, 2009 from 8:30am - 9:30am
*** Please check back for 2010 dates or email TRP@childrens.harvard.edu to join the announcement list for future sessions.
PRESENTERS:
Matt Wladkowski & Adam Simmons
PRESENTATION MATERIALS
|
|
|
|
Presentation Slides - 11.5.09
|
|
|
|
Regulatory Affairs - Key Contacts Sheet
|
|
|
|
The 10 Questions Every Clinical Researcher Should Ask BEFORE Doing Research With a DRUG or DEVICE?
|
|
|
OVERVIEW:
This session discusses investigator responsibilities and various resources at CHB that can facilitate clinical and translational research. Breakfast will be provided. Participants are introduced to federal requirements for studies involving drugs, devices and biologics. At the end of the session, participants will understand when they need an IND or IDE, as well as support resources for research available at CHB. Following the presentation, there is a meet and greet session with various officers across the hospital, including Regulatory Affairs who can aid with IND/IDE applications, CRP, CCI (IRB), EQuIP, CTO, CTSU, Research Pharmacy, and Research Nursing.
TARGET AUDIENCE:
All clinical, translational and basic researchers who are or may be planning studies involving patients or patient samples at Children's Hospital Boston.
SPONSORS:
This event is co-sponsored by the Translational Research Program (TRP) and the Clinical Research Program (CRP) in collaboration with the Education and Quality Improvement Program (EQuIP), Clinical Trials Office (CTO), and the Technology and Innovation Development Office (TIDO) at Children?s Hospital Boston.
ADDITIONAL INFORMATION:
Please contact Maya Levine, TRP Education Coordinator at Maya.Levine@childrens.harvard.edu or x.
4-2927.
|
|
|
|
|
|
|
