Webinar on FDA Acceptance of Foreign Clinical Studies Not Conducted Under An IND

Website http://bit.ly/1pSupNM | Edit Freely

Category Webinar, Health, Medical, Pharma, Clinical, Food / Drugs

Deadline: April 29, 2014 | Date: April 29, 2014

Venue/Country: USA, U.S.A

Updated: 2014-03-11 15:35:07 (GMT+9)

Call For Papers - CFP

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

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/1pSupNM