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Key Stakeholders to Discuss Regulatory Issues Related to the Use ofStudy...

New Orleans, LA.

Horsham, PA (Vocus) September 2, 2009 --The Drug Information Association (DIA) (http://www.diahome.org/) Study Endpoints Special Interest Area Community (SIAC) will host Measuring Study Endpoints in Multinational Clinical Trials: Outcomes Reported from the Viewpoint of the Clinician, Patient, and Caregiver (http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspxproductID=20481's38;eventType=Meeting) from October 26-27, 2009 in New Orleans, LA.

Representatives from industry, FDA, and EMEA will convene to discuss the scientific and regulatory issues surrounding the use of study endpoints in support of medical product labeling claims. Sessions will discuss common principles for the development and validation of all study endpoint measures and the relationships between entry criteria and outcome measurement and between different types of endpoint measures. Specific sessions include:

>    Defining Terms and Setting the Regulatory Context

>    Models, Measures and Claims    

>    Evaluating and Demonstrating Content Validity

>    Regulatory Perspective of Content Validity in Pediatric, Caregiver, and Clinician-Reported Outcomes

>    Practical Considerations for Multinational Clinical Trials Defining a Research Agenda for Study Endpoint Measurement and Multinational Clinical Trials

There has been significant discussion, but little consensus with respect to a common set of best practices applicable across all types of study endpoints in clinical trials, says Laurie Burke, MPH, Capt. USPHS, Director, Study Endpoints and Labeling, Office of New Drugs, CDER, FDA. This conference brings together key stakeholders to discuss the conceptual, measurement, and practical issues regarding study endpoints when applied to product development.

Click here (http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspxproductID=20481's38;eventType=Meeting) to register.

About the Drug Information Association (DIA):

DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit www.diahome.org or call 215-442-6100.

Contact:

Joe Krasowski

DIA

+1-215-293-5812

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