Navigation Links
Global Regulators to Discuss Benefit-Risk Approaches of Medicinal Products at DIA Workshop
Date:10/1/2009

The Drug Information Association (DIA) and the US Food and Drug Administration (USFDA) will host Assessing Benefits and Risks of Medicinal Products in Regulatory Decisions from November 3- 5, 2009 in Bethesda, MD.

Horsham, PA (Vocus) September 30, 2009 -- The Drug Information Association (DIA) and the US Food and Drug Administration (USFDA) will host Assessing Benefits and Risks of Medicinal Products in Regulatory Decisions from November 3- 5, 2009 in Bethesda, MD

High-level representatives from FDA, EMEA and Health Canada, along with patient advocates, industry professionals, and academics will explore the evolving world of benefit-risk assessment. Featured regulatory participation will include:

 
  • Eric Abadie, MD, European Medicines Agency (EMEA)
  • Janet Woodcock, MD, CDER, FDA
  • Kaoru Misawa, Pharmaceuticals and Medical Devices Agency (PMDA)
  • Robyn Lim, Health Canada

Participants will learn how scientific approaches applied in other fields can aid in decision analysis, approaches and methods to enhance transparency and communication of benefit-risk decisions, ways to overcome the challenges of implementing exploratory approaches to benefit-risk assessment in a regulatory framework, and processes and methods that may enhance regulatory decision making. Session topics will include:
 
  • Ongoing Initiatives to Test Structured Benefit-Risk Assessments
  • Methods for Valuing Risks and Benefits
  • Case Studies of Benefit-Risk Assessment
  • The Place of Models for Benefit-Risk Assessment
  • Processes for Reaching Group Decisions on Benefit-Risk Assessments
  • Characterizing Uncertainty: Grappling with the Unknown
  • Interfacing Benefit-Risk Assessment with Health Technology Assessment and Comparative Effectiveness for the Payor’s Perspective
  • Integrating Benefit-Risk into Early Development of New Products
  • Communicating Benefit-Risk to the End User—Patients
  • Panel Session with representatives from FDA, EMEA, PMDA, Health Canada, academia and patient advocacy groups
Baruch Fischhoff, PhD, Howard Heinz University Professor, Department of Social and Decision Sciences
Carnegie Mellon University; Chair, FDA Risk Communication Advisory Committee, will deliver the keynote address.

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.

###

Read the full story at http://www.prweb.com/releases/Drug_Information_FDA/Medicinal_Products/prweb2971364.htm.


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

Related biology technology :

1. Global Biofuels Growth to Double by 2015
2. DIA Conference to Provide FDA, EMEA, Health Canada, Emerging Regions, NGO, and Industry Perspectives on Global Vaccine Development
3. Global Public Health the Focus of Scientific Conference
4. Global Med Technologies(R) Signs Binding LOI With European Company for Breakthrough Transfusion Safety RFID Product
5. Cell Therapeutics Added to the NASDAQ OMX Global Biotechnology Index
6. Fortebio, Inc. to Present at UBS Global Life Sciences Conference
7. Arena Pharmaceuticals to Present at the UBS Global Life Sciences Conference
8. Covance to Present at UBS Global Life Sciences Conference
9. NeurogesX to Present at UBS Global Life Sciences Conference
10. Clinical Trials Move to Emerging Regions, Heighten Need for Local Risk Consulting: Aon Global Risk Map
11. Kensey Nash to Present at the 2009 UBS Global Life Sciences Conference
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Global Regulators to Discuss Benefit-Risk Approaches of Medicinal Products at DIA Workshop
(Date:12/8/2016)... USA, and CARDIFF, UK (PRWEB) , ... December ... ... with very high precision light to control cells — optogenetics — is key ... the current state of the art, spatially patterned light projected via free-space optics ...
(Date:12/8/2016)... Oxford Gene Technology (OGT), The Molecular ... with the launch of the SureSeq myPanel™ NGS Custom FH ... familial hypercholesterolemia (FH). The panel delivers single nucleotide variation (SNV) ... panel and allows customisation by ,mix and match, of fully-optimised ... LDLR , P C SK9 , ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... flexible packaging for their exceptionally efficient human mesenchymal stem/stromal cell (hMSC) expansion ... of bioprocess media products engineered to radically streamline culture processes, minimize processing ...
(Date:12/8/2016)... 8, 2016  Soligenix, Inc. (OTCQB: SNGX) (Soligenix ... on developing and commercializing products to treat rare ... announced today the long-term follow-up data from its ... first-in-class Innate Defense Regulator (IDR), in the treatment ... cancer patients undergoing chemoradiation therapy (CRT).  The additional ...
Breaking Biology Technology:
(Date:12/2/2016)... AUSTIN, Texas , Dec. 1, 2016 /PRNewswire/ ... provider, today announced BioLock , an electrocardiogram ... and health monitoring, a key IoT asset. The ... embedded into a vehicle,s steering wheel and mobile ... a simple touch. As vehicle technology ...
(Date:11/29/2016)... , Nov. 29, 2016   ... identification and object recognition technologies, today released ... for fingerprint recognition solutions that run on ... fingerprint template using less than 128KB of ... compact devices that have limited on-board resources, ...
(Date:11/22/2016)... -- According to the new market research report "Biometric System ... Voice), Multi-Factor), Component (Hardware and Software), Function (Contact and Non-contact), Application, and ... expected to grow from USD 10.74 Billion in 2015 to reach USD ... 2022. Continue Reading ... ...
Breaking Biology News(10 mins):