Navigation Links
Key Stakeholders to Discuss Regulatory Issues Related to the Use of Study Endpoints in Multinational Clinical Trials
Date:9/2/2009

The Drug Information Association (DIA) 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 from October 26-27, 2009 in New Orleans, LA.

Horsham, PA (Vocus) September 2, 2009 --The Drug Information Association (DIA) 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 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 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

###

Read the full story at http://www.prweb.com/releases/2009/09/prweb2822344.htm.


'/>"/>
Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Related medicine news :

1. ABMS and NQF Convene Summit on Enhancing Physician Performance: Stakeholders Agree Board Certification Should Play Bigger Role in Healthcare Quality Improvement
2. Patient-Centered Primary Care Collaborative Stakeholders Come to Washington, DC for July Working Meeting
3. Key Stakeholders Convene Capitol Hill Symposium To Advance Convergence of Behavioral Economics and Healthcare
4. HIMSS Electronic Health Record Association Reaches Out to Key Stakeholders on Meaningful Use of Certified EHRs
5. Major Stakeholders in Health Reform Debate Call for Greater Focus on Disease Prevention and Management in Senate Finance Committees Policy Options Paper
6. Major Stakeholders in Health Reform Debate Call for Improvements in Scoring of Congressional Health Care Proposals
7. Patient-Centered Primary Care Collaborative Stakeholders Convene in Washington, DC for Working Meeting
8. Stakeholders and public should use 20 specific health indicators
9. Leading Government and Advocacy Stakeholders Engage in Public Health Dialogue on Improving Disposal of Unused Medications
10. Newly Formed Consortium to Combat Medical Fraud Announces National Agenda to Intensify Fight Against Health Care Fraud Goals: Collaboration Across Industries; Alignment of Resources; Increased Awareness Among Public and Private Stakeholders Including Fede
11. ADA Calls for All Stakeholders to Work Together to Help Medicaid
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Key Stakeholders to Discuss Regulatory Issues Related to the Use of Study Endpoints in Multinational Clinical Trials 
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... ... offices in Houma, LA, celebrates the beginning of a new charity campaign. As ... assist Court Appointed Special Advocates (CASA). In the belief that children deserve a ...
(Date:2/8/2016)... ... February 08, 2016 , ... If you are feeling that your clothes are ... alone. According to the Center for Disease Control and Prevention (CDC), 34.9% of U.S. ... certain types of cancer, some of the leading causes of preventable death. February ...
(Date:2/8/2016)... ... February 08, 2016 , ... Local insurance agency ... Venice, FL area, has initiated a fundraiser for a two year old little ... days after Christmas. To support this beautiful child who is facing life’s journey ...
(Date:2/8/2016)... ... February 08, 2016 , ... Eating disorders and post-traumatic ... of women and men with eating disorders report a history of trauma, research ... development of an eating disorder. , At the 2016 iaedp Symposium, the ...
(Date:2/8/2016)... ... February 08, 2016 , ... The Association of ... AHCC and the Home Health and Hospice ICD-10 Transition Workgroup are working closely ... coding guidance and clarifications, to address concerns over the use of 'A' as ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... , Feb. 8, 2016  Echo Therapeutics, ... device company focused on non-invasive continuous glucose ... today announced that it will host a ... 17, 2015 at 9:00 a.m. Eastern Time ... its corporate strategy, advancements in its CGM ...
(Date:2/8/2016)... , Feb. 8, 2016 ... the "Global Skin Protective Equipment Market 2016-2020" ... --> http://www.researchandmarkets.com/research/fqx6nz/global_skin ) has announced the addition ... 2016-2020" report to their offering. ... ) has announced the addition of the ...
(Date:2/8/2016)... , Feb. 8, 2016   HighPoint ... November Research Group (NRG),s pharmacovigilance technology services division.  ... consulting services and an Oracle Argus Specialized partner, ... to Life Sciences companies. --> ... expands HighPoint,s life sciences capabilities and provides a ...
Breaking Medicine Technology: