Goals: To provide a comprehensive in-depth exposure to current regulatory affairs concepts and controversies.
Audience: K12 and K08 awardees, T32 trainees, fellows and faculty, MD Anderson faculty, new investigators, clinical research investigators, advanced research nurses and coordinators.
Topics include issues pertaining to: Information resources,Biological IND and IDE applications, Intellectual property, Commercialization of drugs/devices, Conflicts of interest, Data and safety monitoring, Confidentiality, Human derived biological samples, Genome wide association studies, Informed consent, Clinical trial agreements.
Format: Case and problem based with a blend of didactic presentations and active discussion, assigned reading and questions.
Location: MSB B620
Dates and Time: 10 meetings, 2nd and 4th Monday per month at 5:30-7:00 pm
Orientation/Introductions August 25, 2008 5:30 – 6:30 pm
Meeting 1
Sept. 8, 2008
Meeting 6
Nov. 24, 2008
Meeting 2
Sept. 22, 2008
Meeting 7
Dec. 8, 2008
Meeting 3
Oct. 13, 2008
Meeting 8
Jan. 12, 2009
Meeting 4
Oct. 27, 2008
Meeting 9
Jan. 26, 2009
Meeting 5
Nov. 10, 2008
Meeting 10
Feb. 9, 2009
Textbook: Coleman, C. H., Menikoff, J. A., Goldner, J. A., & Dubler, N. N. (2005).The Ethics and Regulation of Research with Human Subjects. Newark, New Jersey: Mathew and Binder & Company, Inc.
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Number of Participants: 25 Maximum Materials Provided: Textbook, binder Certification: CMEs, CEUs, Certificate of attendance
Attendance is mandatory
Light meal will be provided.
