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Making All Data Count: FDA Acceptance of non-US Clinical Trials
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.
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.
- Comparison of US and non-US regulatory requirements for clinical trials
- Types of clinical trials with regards to product development and marketing approval
- Parameters of quality of clinical trials: investigators and sites
- Acceptable design of non-US clinical trials
- Acceptable ethical and human subject protection practices
- Acceptable data collection, analysis, monitoring, and documentation practices
- Role of IRBs, ethics committees and other regulatory bodies in clinical trial quality control
- FDA’s opinion of non-US regulatory review and approval of clinical trials
- FDA’s international clinical trial initiatives
- FDA audits of non-US clinical sites
- Best practices for using non-US human experience with products marketed outside US
- Waiver and other options for non-IND clinical trial data
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
- Compliance/Regulatory affairs professionals
- Clinical trial professionals
- Sponsors and investigator-sponsors of clinical trials that use non-US sites
- Project Managers for clinical trials
- Senior management for companies interested in non-US trials
- People investing in FDA-regulated product development projects
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.
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.
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."
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