Chair: Dennis W. Raisch, PhD, MS, RPh Professor, PEPPOR  Pharmacoeconomics, Epidemiology, Public Policy and Outcomes Research, College of Pharmacy, University of New Mexico Albuquerque, NM, USA

Goal:
Identify and describe the links between RBM and health outcomes research in public policy and health care decision-making to assure the safe and effective use of pharmaceutical products and devices.

	Metrics & Methodologies to Quantify Risks & Benefits Working Group
	Direct to Consumer Advertising (DTCA) Working Group
	Head to Head Comparison of EMEA to US RBM Guidelines Working Group
	Ethical Considerations for RBM in Biotechnology Working Group

Accomplishments:

2010

• March 2010
  “Review of Current Risk-Benefit Assessments for Drug Safety - Report of the ISPOR Risk-Benefit Management Working Group” was accepted for publication in the August 2010 issue of Value in Health.

2009

• May 20, 2009  ISPOR 14th Annual International Meeting.  Orlando, FL, USA
  Workshop:  A Review of Current Risk-Benefit Assessments for Drug Safety
  Presenters: Guo J, Swapnil P, Doyle J. Raisch DW

2008

• May 4, 2008  ISPOR 12th Annual International Meeting. Toronto, ON, Canada
  Short Course: Risk Benefit Assessment: Analysis and Management
  Faculty: Raisch DW, Lockett A, Curkendall S.

2007

• ISPOR Comments on FDA Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
• FDA: Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
• Notice of Public Hearing; Request for Comments

• May 20th, 2007  ISPOR 12th Annual International Meeting
  Short Course:  Introduction to Risk/Benefit Management in Health Care
  Faculty: Dennis W. Raisch, PhD, RPh, BS, MS; Anthony Lockett, MD, PhD, MBA;
  Suellen Curkendall, PhD
  

2006

• May 22, 2006 ISPOR 11th Annual International Meeting
  Forum: International Perspectives Regarding Pharmaceutical Risk Management
  Moderator: Dennis Raisch, PhD, RPh, BS, MS
  Speakers: Suellen Curkendall PhD; Larry Liu MD, PhD; Anthony Lockett MBA, MD, PhD; Ateequr Rahman MBA, PhD
  
• May 21, 2006  ISPOR 11th Annual International Meeting
  Short Course: Risk Assessment: Analysis and Management
  Faculty: Dennis W. Raisch, PhD; Anthony Lockett, MD, PhD, MBA; Suellen Curkendall, PhD
  

2005

• ISPOR Risk Management Special Interest Group - A Plan for Action
  ISPOR CONNECTIONS Vol. 11 No 5: October 15, 2005
• May 8, 2005 ISPOR 10th Annual International Meeting
  Workshop: Balancing Risks and Benefits of Healthcare Treatments in the 21st Century
  Speakers: Dennis Raisch BS, MS, PhD, RPh; Larry Liu MD, PhD; Paul Stang MS, PhD; Ateequr Rahman MBA, PhD; Anthony Lockett MBA, MD, PhD; Nicholas Lipskiy MBA, PhD; Suellen Curkendall PhD
  May 8, 2005 ISPOR 10th Annual International Meeting
  Workshop: ISPOR Member Perspectives: How Do Individuals Perceive Risks and Benefits of Pharmaceuticals in Comparison with Other Non-Medical Activities
  Speakers: Dennis Raisch BS, MS, PhD, RPh; Larry Liu MD, PhD; Paul Stang MS, PhD; Ateequr Rahman MBA, PhD; Anthony Lockett MBA, MD, PhD; Nicholas Lipskiy MBA, PhD

2003

• November 2003 ISPOR 6th Annual European Congress
  Forum: Exploring Risk Assessment in the Development of Pharmaceuticals in Europe 
  Moderator:Anthony Lockett, PhD, MD, DMS
  Speaker: Peter Davey MD, FRCP
• May 2003 ISPOR 8th Annual International Meeting
  Issue Panel: Looking for Signals and Targeting Interventions
  Chairs: Louis Morris PhD; Eva Lydick PhD
  Panelists: John Urquhart, MD, FRCPE; Judith Jones MD, PhD
• May 2003 ISPOR 8th Annual International Meeting
  Forum Presentations
• “FDA Concept Paper: Pre-marketing Risk Assessment”
• “FDA Concept Paper: Risk Management Programs”
• “FDA Concept Paper: Risk Assessment of Observational Data: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment”
• April 2003 FDA Risk Management Public Workshop
  ISPOR Comments on FDA Risk Management Concept paper FDA hearing letter
• FDA Risk Management Concept Paper
• FDA Risk Management Workshop announcement