3rd FDA Clinical Investigator Training Course at the National Labor College

July 19, 2011

Dear International Colleague:
 

I am writing today to invite you to an exciting training opportunity we hope you might find of interest. On November 7 - 9, 2011 , the United States Food and Drug Administration's (FDA) Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI) will cosponsor a revamped 3rd FDA Clinical Investigator Training Course at the National Labor College, 10000 New Hampshire Avenue, Silver Spring, Maryland 20903. This training is for clinical investigators and is not open to the phannaceutical industry or non-regulatory authOlities. The training session will be in English and unfortunately, there are no provisions for interpretations during the Training Course.

This intensive, three-day course will enable clinical investigators to gain a greater appreciation of the scientific, ethical, and regulatory issues relating to clinical trial data that may be submitted to regulatory bodies. Investigators will learn about the design, conduct an analysis of clinical trials; regulatory considerations for clinical research; preclinical and pharmacological issues; safety assessments; inclusion of special populations in clinical studies; and the role of personalized medicine in the future of medical product development. This year, the Training Course will include a Question and Answer Session, as well as extended breakout sessions dealing with biologics, devices, and drugs. I have enclosed a draft agenda of the Training Course for your consideration.

The program fee is $400.00 USD. Regrettably, we are unable to provide financial assistance for attendees. To register, please go to: https://www.trialstransformation.org/fda-clinical-investigator-training-course. Registration ends at 5:00 p.m. EST on October 28, 201 1. The course is open to the first 400 registrants.

The National Labor College is offering rooms for Training Course attendees at a group rate of $199.00 USD, plus tax, per night. This rate includes meals. To book a room, please call 301.431.6400 and ask for a room under Group Block Code "FDA Clinical Investigator Course." You may also book a room by going to: https://www.trialstransformation.org/accommodations.

Please direct any questions or concerns to the FDA Office of Critical Path Programs at: 301.796.8490. I hope you will be able to join us.

Best Regards,

---/s/---

Mary Lou Valdez, MSM
Associate Commissioner for International Programs

International Outreach to Foreign Embassies