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

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

Instructor Profile:

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( www.amarexcro.com ). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Background:

In May 2011 FDA released a new guidance document about the financial disclosure requirements for clinical trials conducted under an IND or an IDE. This guidance document was created primarily to address several concerns raised by a government investigation of the financial conflict of interest in clinical trials. In that investigation, it was found that most sponsors were deficient in collecting financial conflict of interest information. It was found that the financial disclosure information submitted to the FDA was mostly insufficient and incomplete, and even that FDA did not adequately assure that the financial conflict of interest did not exist.

The new guidance document clarifies several common questions about financial disclosure information in clinical trials such as (1) the sponsor's responsibility to collect the financial disclosure information prior to an investigator participating in a study, (2) sponsor’s responsibility to ensure that all required forms and attachments are submitted in marketing applications; (3) FDA’s expectations for completeness and current-ness of information, and (4) FDA’s current processes for review of financial disclosure information. Further, the guidance also describes what FDA could disclose publicly about financial disclosure information related to an approved marketing application.

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