FDAs 2011 Draft Guidance on Financial Disclosure by Clinical Investigators (Clinical Compliance )

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Nov 11, 2011 End Date/Time: Nov 11, 2011
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This Webinar will highlight the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure information to be submitted in the marketing applications to FDA.

This Webinar will address the most pressing changes and answers questions FDA has received from industry and the public. While the “draft” offers much-needed clarification on certain regulatory requirements as well as invaluable insight into FDA’s current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.

Areas Covered in the Seminar:

- Review proposed changes to the 2011 released draft guidance.
- Clarification on definition of sponsor.
- Understand FDA's clear actions that can and will be taken regarding refuse to file a marketing application.
- Time period covered by regulations.


Online Event
2600 E. Bayshore Road
Palo Alto
United States