Navigation Links
Global Regulators to Discuss Benefit-Risk Approaches of Medicinal Products at DIA Workshop
Date:9/30/2009

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.

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 medicine news :

1. Prodigy Diabetes Care LLC Expands Global Reach to European Diabetes Patients
2. MarketsandMarkets: Global Neurostimulation Market Worth US$10.2 Billion by 2014
3. MarketsandMarkets: Global Home health Care Market Worth US$159.6 Billion by 2014
4. Innovation and Global Clinical Trial Participation are the Focus of CenterWatch's Latest Special Report on China's Drug Development Industry
5. Building the Next Generation of Global Leaders - Maternal Health Task Force and Ashoka Partner
6. Gates Foundation Launches Campaign to Highlight Success of U.S. Global Health Investments
7. Plan USA Given Exclusive Honor at Clinton Global Initiative
8. PSI Commits to Expanding HIV Prevention at Clinton Global Initiative
9. Clinton Global Initiative Highlights the Freeplay Foundation as Featured Humanitarian Organization
10. Miss Universe Organization, Global Network for Neglected Tropical Diseases Join Forces to Eliminate Neglected Tropical Diseases in the Americas
11. Capstone Global Markets Hosts Charity Day to Help 4-Year Old Boy and Others Battling Batten Disease
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Global Regulators to Discuss Benefit-Risk Approaches of Medicinal Products at DIA Workshop
(Date:6/20/2017)... ... ... Fresenius Vascular Care, a national network of outpatient vascular care and ambulatory ... range of vascular conditions, has today announced its new name, Azura Vascular Care, as ... than 40 local brands, a phased rollout of the new brand across all locations ...
(Date:6/20/2017)... ... June 20, 2017 , ... ... that the introduction of school choice can promote economic development in economically distressed ... that has, according to the report, contributed to the economic development of the ...
(Date:6/20/2017)... ... ... AMC Health , the leading provider of proven real-time virtual care ... to its approach in demonstrating positive outcomes in the healthcare market, AMC Health has ... of eVisits to support virtual studies. , In a study concluded this ...
(Date:6/20/2017)... ... June 20, 2017 , ... Leading dental clinicians, Drs. Ashlyn ... with the VATECH PaX-i and Anatomage systems. With advanced digital images and modeling capabilities, ... place dental implants precisely and restore oral health for those who are missing ...
(Date:6/20/2017)... ... 20, 2017 , ... As a leading dental practice, Wall Centre Dental supports ... disease. Those with bleeding gums in Vancouver, BC, may be developing gingivitis, the first ... heart disease, stroke and diabetes. Drs. Parviz Roshan, Siamak Tehrani and Milton Reskovich offer ...
Breaking Medicine News(10 mins):
(Date:6/5/2017)... 2017 Kohll,s Pharmacy & Homecare is the first distributor ... States . The Raizer is a simple battery operated ... to an almost-standing position within a few minutes. ... assistant and does not require any extra effort besides ... child can operate it, and lightweight and portable ...
(Date:5/30/2017)... CAESAREA, Israel , May 30, 2017 DarioHealth Corp. ... and big data solutions, today announced that it will be presenting ... 2017, at 8:00 AM PT. Erez Raphael , CEO, of ... The conference will be held on June 6th & 7th, ... 180 companies in the small / micro-cap space. ...
(Date:5/26/2017)... , May 26, 2017  Endo International plc (NASDAQ: ... , President and CEO, will represent the Company in a ... Healthcare Conference on Tuesday, June 13, 2017 at 10:40 a.m. ... at Terranea Resort in Rancho Palos Verdes, CA. ... for the event will be available on the Company,s website ...
Breaking Medicine Technology: