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Making All Data Count: FDA Acceptance of non-US Clinical Trials

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This webinar on FDA acceptance of non-US clinical trials will discuss the current FDA requirements for using clinical data from non-IND/IDE clinical trials in support of an IND and/or marketing approval application.

Speaker
Instructor: Mukesh Kumar
Product ID: 702281

Why Should You Attend:

FDA acceptance criteria for non-IND/IDE clinical trials are based on internationally recognized standards of quality, ethics, and practices for human subject protection. An adequately designed non-US study can be used to greatly reduce the time and cost of getting the tested product to the US market.

If you have conducted non-IND clinical trials at non-US locations or if you would like to understand how non-IND trials can be used successfully to support an IND/IDE or a marketing approval application, this webinar is a must for you. The speaker will share his extensive experience in multi-national IND and non-IND studies to underscore the critical issues that need to be addressed when using non-US data for discussions with FDA. Case studies from drugs, biologics, diagnostic kits and medical devices will be used to highlight product specific issues with non-US clinical trials.

Areas Covered in the Webinar:

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

Instructor Profile:

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the regulatory affairs and quality assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in over 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has made regulatory submissions in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia.

Dr. Kumar 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 in several professional and academic organizations worldwide. Dr. Kumar has a PhD in Biochemistry and is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Background:

FDA accepts data from non-US clinical trials for all stages of product development. Being able to use clinical data from a non-IND non-US clinical trial could greatly reduce the additional studies needed under an IND thereby reducing the cost and time for developing a given product for the US market. It is even possible to rely solely on foreign clinical data as support for an IND or marketing approval application in the U.S. However, a non-IND/IDE clinical trial must meet several conditions before data generated in it can be acceptable for US applications. Recently FDA released a new guidance document describing in great detail the many conditions a trial must meet before being acceptable to it.

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Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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