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

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:

• 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 FDA-regulated product development projects

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 and 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 affair 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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