FDA Boot Camp: Understanding the Clinical Trial Process for Drugs and Biologics
Amy K. Dow, Associate, copresents "Understanding the Clinical Trial Process for Drugs and Biologics" at ACI's FDA Boot Camp.
- Overview of the clinical trial process
- phases of testing (I-IV)
- which are mandatory?
- what happens in each phase?
- who conducts the testing?
- special considerations for Phase IV testing
- Regulatory requirements
- informed consent
- sponsor obligations
- investigator obligations
- FDA authority
- refusal to accept data
- clinical hold
- disqualification of irb and/or investigator
- Other issues
- who reviews the data?
- how do clinical trials for drugs differ from clinical trials for biologics?
- Disclosure of clinical trial information
- FDA Amendments Act of 2007
- FDAMA § 113
- PhRMA policies
For more information, visit AmericanConference.com.