This Webinar will help you understand the current FDA requirements regarding financial disclosure in clinical trials. It will discuss differences from the older requirements, and tips to assure compliance all through from the start of clinical trials till the submission of data in a marketing approval application.
You can get valuable tips and training in less than an hour on practical methods for collecting financial disclosure information from all clinical investigators in your clinical trial. This webinar will also discuss acceptable methods to collect financial disclosure information from international investigators. This seminar will discuss the new requirements, differences from the older requirements, and tips to assure compliance all through from the start of clinical trials till the submission of data in a marketing approval application.
How and when to collect and report the financial disclosure information.
Specific concerns for different kind of products: drug, biologic and medical device.
Forms to be used for collecting this information.
What needs to be disclosed?
Changes in financial disclosure information during a trial.
Who is covered and who is responsible for reporting to FDA?
What kind of clinical trials are covered under the current rules?
What would FDA reviewers of marketing approval application and FDA auditor's look for in financial disclosure data?
Why Should You Attend:
If your company or organization is sponsoring clinical trials for a drug, biologic medical device or a diagnostic kit; if you are a clinical investigator, co-investigator or sub-investigator participating in a clinical trial; if you are with an IRB overseeing clinical trials, or if you are senior management in a company sponsoring clinical trials, this webinar will help you understand the current FDA requirements regarding financial disclosure.You can get valuable tips and training in less than an hour on practical methods for collecting financial disclosure information from all clinical investigators in your clinical trial. This webinar will also discuss acceptable methods to collect financial disclosure information from international investigators. This seminar will discuss the new requirements, differences from the older requirements, and tips to assure compliance all through from the start of clinical trials till the submission of data in a marketing approval application.
Areas Covered in the Seminar:
Clarification of the definition of financial interest. Types of clinical investigator financial interests that you must report..How and when to collect and report the financial disclosure information.
Specific concerns for different kind of products: drug, biologic and medical device.
Forms to be used for collecting this information.
What needs to be disclosed?
Changes in financial disclosure information during a trial.
Who is covered and who is responsible for reporting to FDA?
What kind of clinical trials are covered under the current rules?
What would FDA reviewers of marketing approval application and FDA auditor's look for in financial disclosure data?
Who Will Benefit:
This webinar will provide valuable assistance to the following personnel:- Compliance/Regulatory affairs professionals
- Clinical trial professionals (e.g., CRAs, coordinators)
- Investigators participating in clinical trials
- Sponsors and investigator-sponsors of clinical trials
- Clinical trial specialists
- Project Managers
- People investing in FDA-regulated product development projects
Course Provider
Mukesh Kumar,
