Compliance alliance: FDA meetings slated for 2009

IRB members can interact with regulators

A series of two-day regional conferences will be held next year focusing on Food and Drug Administration clinical trails requirements, regulations and compliance issues. The program will focus on the relationships among the FDA and clinical trial staff, investigators and IRBs. The workshop will highlight three areas that present challenges to sponsors and investigational sites: FDA Clinical Research Requirements, Enhancing Success through Communication and Financial Incentives, and Assuring Confidence in Clinical Research.

Jointly sponsored by FDA district/regional offices and the Society of Clinical Research Associates, the conferences will be held in Seattle (April 8-9); Minneapolis (June 10-11); and Pittsburgh (Oct. 21-22). The conference is designed to aid clinical research professional's understanding of the mission, responsibilities and authority of the FDA and to facilitate interaction with FDA representatives. According to the conference learning objectives, some of things participants will be able to discuss at the end of the sessions include:

  • The role of the FDA District Offices, how they are structured and their responsibilities
  • FDA expectations of a pharmaceutical clinical trial
  • The science, regulation and assessment of adverse events
  • How studies with Investigational devices differ from those with drugs and biologics
  • Regulations that apply to the informed consent process
  • How the ethical principle of justice underlies responsible participant selection
  • IRB regulations and FDA mechanisms to assure compliance
  • The parameters included in regulations applying to electronic signatures
  • How FDA small business representatives assist the research community
  • The responsibilities of the clinical investigator
  • The sponsor/investigator's legal responsibilities, additional duties and concerns
  • How the FDA's Center for Biologics regulates research
  • The array of actions taken when research fails to meet standards enforced by the FDA

For more information on the conference go to: http://www.socra.org/html/FDA_Conference.htm.