ComplianceOnline

Register

Toll Free: +1-888-717-2436


customer care
Fax: +1-650-963-2556
Email: editor@complianceonline.com
Read Frequently Asked Questions

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

Buy Now Section

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 of 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 seminar 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:

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

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. 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:

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.

Bookmark and Share
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.

Trade Compliance Seminar - Harmonized Tariff Schedule/Schedule B and NAFTA Rules of Origin and Documentation - 80168SEM
Risk Assessment, Assessing Internal Controls and Financial Statement Audit - 80225SEM

This training hasn't been reviewed yet.

Review this training

Training Options Training Duration = 90 Min
$299.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$549.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days