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.

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.