FDA Acceptance of Foreign Clinical Studies Not Conducted Under An IND
April 29, 2014 - Fremont CA USGlobalCompliancePanel
globalcompliancepanel@gmail.com
Phone:8004479407
Fax:302 288 6884
Overview: This webinar will discuss FDA's criteria for acceptance of foreign clinical trials whether conducted under an FDA submission or not conducted under an FDA submission. Clinical research is becoming increasingly global. FDA recognizes Sponsors may decide to use clinical data that is obtained from foreign sites to support clinical investigations and/or marketing approval in the USA. Some Sponsors may even seek to rely solely on foreign clinical data for an FDA investigational or marketing application. This webinar will review criteria for FDA acceptance of foreign clinical studies/data. Why should you Attend: The advent of global clinical studies have caused FDA to revise their policies relative to foreign studies. FDA's new foreign clinical criteria addresses FDA requirements for all foreign clinical trials – those conducted under a FDA submission and those clinical trials not conducted under an FDA submission. Unless these criteria are met FDA will not accept the foreign clinical study/ data. This webinar addresses all the FDA criteria requirements and what must be done to have FDA accept your foreign clinical study/data. Areas Covered in the Session: FDA criteria for acceptance of foreign clinical studies/data Information required by FDA for use of foreign clinical studies/data FDA required information on the product FDA required information on the Investigator FDA information required on the IRB/IEC Records for FDA review Who Will Benefit: Regulatory Affairs Personnel Clinical Personnel Research Personnel Quality Personnel Legal Personnel Personnel who require a general understanding of the FDA's acceptance of foreign clinical studies/data Albert A. Ghignone MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. Quick Contact: GlobalCompliancePanel USA Phone:800-447-9407 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Event Link - http://bit.ly/1kpO4Ui