FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators - Webinar By GlobalCompliancePanel

Key Topics

• Clarification on definition of sponsor
• Proposed changes to the 2011 released draft guidance
• Submitting a financial disclosure information to FDA
• FDA’s clear actions that can and will be taken regarding refuse to file a marketing application
• Timing of data collection and purpose
• Why FDA is expounding on due diligence and its significance
• Update regarding financial disclosure questionnaires
• How financial information should be disclosed to FDA
• Clarification on covered clinical study
• Time period covered by regulations
• Factors for FDA review of disclosed financial interests

Who should Attend

Clinical Affairs, Regulatory Affairs, Quality and Compliance, Investigators, Distributors/Authorized Representatives, Marketing & Sales, Consultants and Legal Counsel.