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:8/17/2017)... (PRWEB) , ... August 17, 2017 , ... ... care professionals, today announced that it has raised $1.675 M in seed funding ... Rethink Education, Lumina Foundation, and Techstars Venture Capital Fund are the company’s primary ...
(Date:8/17/2017)... Ca (PRWEB) , ... August 17, 2017 , ... Centrifugation ... useful tools in the laboratory that we can no longer do without. And just ... the lifetime of your device. , In this webinar, attendees will learn about the ...
(Date:8/16/2017)... , ... August 16, 2017 , ... The next Patient ... being accepted. , Students who successfully complete the seven-week long Patient Care Academy ... Assistant (CNA). The average starting salary for a CNA in Kalamazoo is $24,428.* , ...
(Date:8/16/2017)... ... August 16, 2017 , ... The Data Council, ... that it was acquired by Advantage Solutions. The Data Council’s IX-ONE platform ... include the industry’s leading suppliers, brokers, distributors and retailers. The Data Council will ...
(Date:8/16/2017)... ... August 16, 2017 , ... QualDerm Partners , a ... today announced Cumberland Skin Surgery and Dermatology has joined the company ... in both Hermitage and Lebanon, Tennessee, provides comprehensive general dermatology and skin cancer ...
Breaking Medicine News(10 mins):
(Date:8/10/2017)...  Physical Rehabilitation Network (PRN), acquired the long-standing outpatient rehabilitation ... . The reputable clinic will continue to be co-owned ... his staff of four clinicians. Lipkin received his doctorate in ... 10 years of experience with a strong background in manual ... the 10th PRN clinic in and around the Denver ...
(Date:8/7/2017)... -- Diplomat Pharmacy, Inc. (NYSE: DPLO ) today ... effective Aug. 7, 2017. ... interests and will serve as president emeritus during a planned, ... in multiple leadership roles since he joined Diplomat with the ... provided decisive, strategic leadership which continues to benefit our patients ...
(Date:8/3/2017)... 3, 2017  Opioid addiction and other drugs of ... costs and threatening outcomes, were problems taken on directly ... industry that support them, met this week. This according ... that drugs of abuse, procalcitonin and acute kidney injury ... organization,s 69th meeting in San Diego, CA. ...
Breaking Medicine Technology: