CLINICAL COMPLIANCE 2011 - What are the Scientific Basis of Clinical Research and the hall mark of a good study protocol? - Clinical webinar By ComplianceOnline

Website http://complianceonline.com/ecommerce/control/trainingFocus/~product_id=701843?channel=ourglocal | Edit Freely

Category Clinical Webinar ,conference,event.

Deadline: January 07, 2011 | Date: January 07, 2011

Venue/Country: Palo Alto, U.S.A

Updated: 2010-12-23 19:34:35 (GMT+9)

Call For Papers - CFP

The basis for determining that a drug or device is “Safe and effective” is a series of scientifically sound, appropriately blinded, statistically relevant, and ethically performed process and it controlled by the Investigators.

This Webinar goes over the scientific standards of the drug development process. Starting with the drug discovery process, the role of the dose response relationship, the role of the IND process is discussed. You will learn the regulations to follow in Phase I and the 6 major questions that must be answered in this Phase.

The determination of the first dose in humans is another critical point in the process. Learn the questions each Phase in the development process must answer and how that is managed.. In the end, it is the Safety or risk and the efficacy or benefit ratio, which must be favorable for the process to continue.