FDA Boot Camp: Understanding the Clinical Trial Process for Drugs and Biologics

Doubletree Suites Times SquareNew York, NY

Amy K. Dow, Associate, copresents "Understanding the Clinical Trial Process for Drugs and Biologics" at ACI's FDA Boot Camp.

Topics include:

  • 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
    - IRBs
    - sponsor obligations
    - investigator obligations
  • FDA authority

    - inspections
    - refusal to accept data
    - clinical hold
    - disqualification of irb and/or investigator
  • Other issues

    - CROs
    - SMOs
    - 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
    - clinicaltrials.gov
    - PhRMA policies

For more information, visit AmericanConference.com.