FDA's Rules for Financial Disclosure in Clinical Trials Clarified: New Guidance, Practical Application 2012

Key Topics

• Types of clinical investigator financial interests that you must report.
• Clarification of the definition of financial interest
• Specific concerns for different kind of products: drug, biologic and medical device
• How and when to collect and report the financial disclosure information
• What needs to be disclosed?
• Forms to be used for collecting this information
• Who is covered and who is responsible for reporting to FDA?
• Changes in financial disclosure information during a trial
• What would FDA reviewers of marketing approval application and FDA auditor`s look for in financial disclosure data?
• What kind of clinical trials are covered under the current rules?

Who should Attend

Clinical trial professionals (e.g., CRAs, coordinators), Compliance/Regulatory affairs professionals, Sponsors and investigator-sponsors of clinical trials, Investigators participating in clinical trials, Project Managers, Clinical trial specialists and People investing in FDA-regulated product development projects.