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:2/24/2017)... ... ... The Smart Machine Age is here, and it’s disrupting everything. Not only could it ... the United States may be taken over by technology in the next five to ... over colleagues is drawing to a close. Success will belong to those who can ...
(Date:2/24/2017)... ... , ... With millions of Americans and people worldwide struggling ... are aware of our options and are empowered with strength and information throughout ... its newest edition of "Vision and Hearing" in USA Today, that will educate ...
(Date:2/24/2017)... ... 24, 2017 , ... The narrative in “ Signal 8: An Australian Paramedic’s ... of his paramedic experiences. Schanssema describes the tragedies he saw, as well as his ... them. , Schanssema, initially unsure of the career path he wanted to take, found ...
(Date:2/24/2017)... ... February 24, 2017 , ... The California State University Institute ... faculty engaged in or interested in palliative care education and research. The Symposium, ... in North County San Diego on Sept. 28 and 29, 2017, on the campus ...
(Date:2/24/2017)... (PRWEB) , ... February 24, 2017 , ... The International ... 7th annual “Imagine Me Beyond What You See” body image mannequin art competition. Selected ... will be showcased and the winner revealed at the 31st annual iaedp Symposium, March ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... 2017 Research and Markets has announced the ... Strategies - 2016" report to their offering. ... The latest research Autism Spectrum ... data and benchmarks in the global Autism Spectrum Disorder market. ... What are the key drugs marketed for Autism Spectrum Disorder and ...
(Date:2/23/2017)... MINNEAPOLIS , Feb. 23, 2017  Cogentix Medical, ... manufactures and markets innovative proprietary products for the urology ... and fiscal year ended December 31, 2016 before the ... The Company will host a conference call and ... on Thursday, March 9, 2017 at 11:00 a.m. Eastern ...
(Date:2/23/2017)... , Feb 23, 2017 Research and Markets has ... - 2016" report to their offering. ... The latest research Menopause Drugs Price Analysis and Strategies ... market. The research answers the following questions: ... attributes? How are they positioned in the Global Menopause market? ...
Breaking Medicine Technology: