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10/03/2015 11/03/2015 America/Toronto American Conference Institute's 24th FDA Boot Camp American Conference Institute’s 24th FDA Boot Camp
March 10 – 11, 2015
Doubletree Suites by Hilton Times Square, New York, NY
Please visit https://staging.americanconference.com/fda-boot-camp-711l15-nyc/ for more information and updates. Doubletree Suites by Hilton Times Square, New York, NY true DD/MM/YYYY 1440 use-title -
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10/03/2015 11/03/2015 America/Toronto American Conference Institute's 24th FDA Boot Camp American Conference Institute’s 24th FDA Boot Camp
March 10 – 11, 2015
Doubletree Suites by Hilton Times Square, New York, NY
Please visit https://staging.americanconference.com/fda-boot-camp-711l15-nyc/ for more information and updates. Doubletree Suites by Hilton Times Square, New York, NY true DD/MM/YYYY 1440 use-title -
Understanding the Clinical Trial Process for Drugs and Biologics
Daniel A. Kracov
Partner
Arnold & Porter LLP
- Outlining the phases of clinical trials (I-IV)
- Regulatory requirements (e.g., informed consent, IRBs, sponsor obligations, investigator obligations, etc.)
- FDA authority
- Discussing the roles and obligations surrounding CROs and SMOs
- Identifying major differences between clinical trials for drugs and biologics
- Disclosure of clinical trial information
- FDA Amendments Act of 2007
- FDAMA § 113
- clinicaltrials.gov
- PhRMA policies