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 and cost of getting the tested product to the US market.

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

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.

Note:

Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.

For Registration:

http://www.complianceonline.com/fda-acceptance-of-non-us-clinical-trials-webinar-training-702281-prdw?channel=sciencedz