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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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FDA Clinical Trial Requirements, Regulations, Compliance and GCP

May 4 and 5, 2011

Denver, Colorado

Goal: SoCRA is pleased to announce this conference that is jointly sponsored with District/Regional offices of the U.S. Food and Drug Administration. This conference on FDA’s clinical trial requirements is designed to aid the Clinical Research Professional’s understanding of the mission, responsibilities and authority of the FDA and to facilitate interaction with FDA representatives.

Objective: This two-day conference is intended to share information among FDA representatives and the regulated community, to facilitate the understanding of regulations, guidelines and practices, and to suggest methods and opportunities to enhance the research professional’s product development experience. 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.

Learning Objectives: Upon completion of the conference, the attendee should be able to:

  • Discuss the Role of the FDA District Offices, how they are Structured and their Responsibilities
  • Describe what FDA Expects in a Pharmaceutical Clinical Trial
  • Discuss the Science, Regulation and Assessment of Adverse Events
  • Discuss how Studies with Investigational Devices differ from those with Drugs and Biologics
  • Describe the Regulations that Apply to the Informed Consent Process
  • Discuss how the Ethical Principle of Justice underlies Responsible Participant Selection
  • Describe the IRB Regulations and FDA’s Mechanisms to Assure Compliance
  • Describe the Parameters included in Regulations Applying to Electronic Signatures
  • Describe how the FDA Small Business Representatives assist the Research Community
  • Discuss the Responsibilities of the Clinical Investigator
  • Describe how Pre-IND Meetings and the FDA Meeting Process assist the Research Goal
  • Describe the Sponsor/Investigator’s Legal Responsibilities, Additional Duties and Concerns
  • Describe how the FDA’s Center for Biologics Regulates Research
  • Discuss the Array of Actions taken when Research Fails to Meet Standards Enforced by the FDA
  • Describe how the FDA’s Center for Food Safety and Applied Nutrition Regulates Research on Food Additives
  • Describe how the FDA’s Office of Science and Health Coordination, Good Clinical Practice Program, Promotes Confidence in Clinical Research