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- Proposed changes to the 2011 released draft guidance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.
