Activities and Accomplishments (2002-2007):

• ISPOR Comments on FDA Use of Medication Guides to Distribute Drug Risk Information to Patients;
  Public Hearing: ISPORCommentsonFDAMedicationGuidesJuly2007.pdf
  

  FDA: Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing: FDAUseofMedicationGuidetoDistributeDrugRiskInformationtoPatientsPublicHearing.pdf
  Notice of Public Hearing; Request for Comments on FDA website at:
  http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-6506.htm

• ISPOR 12th Annual International Meeting – Short Course May 20th, 2007
  Introduction to Risk/Benefit Management in Health Care
  
  Faculty: Dennis W. Raisch, PhD, RPh, BS, MS, Chair, Risk Benefit Management Working Group and Associate Center Director, Scientific Affairs, VA Cooperative Studies Program, Clinical Research Pharmacy, Albuquerque, NM, Anthony Lockett, MD, PhD, MBA, Medical Director, MEDQP Ltd, Leeds, United Kingdom; Suellen Curkendall, PhD, Principal Investigator, Cerner Health Insights, Vienna, VA
  Description: This course will provide an overview of risk/benefit management for pharmaceuticals and devices. The risk/benefit assessment process will be described in regards to stage of product development, from pre-marketing through post-marketing. Risk mitigation includes the various strategies employed by manufacturers, regulators, and health care providers, with an emphasis on international differences in risk mitigation and decision making. Risk/benefit communication processes will be described, focusing upon how decisions regarding risks and benefits of pharmaceuticals and devices are communicated to health care providers and the public. This includes direct mailing, direct-to-consumer marketing, and labeling. Real-world exercises will allow participants to discuss key topics and propose implementation strategies for risk management. This course is designed for those with a basic understanding of pharmacoepidemiology principles.

• ISPOR 11TH Annual International Meeting Forum Presentation May 22, 2006
  International Perspectives Regarding Pharmaceutical Risk Management
  
  Moderator: Dennis Raisch, PhD, RPh, BS, MS, Risk Benefit SIG Chair, Associate Center Director, Scientific Affairs, VA Cooperative Studies Program Clinical Research Pharmacy, Albuquerque, NM, USA;
  RBM SIG Leadership Group members:
  Speakers: Suellen Curkendall PhD, Principal Investigator, Cerner Health Insights, Vienna, VA, USA; Larry Liu MD, PhD, Director, Anti-Infectives US Outcomes Research, Pfizer, New York, NY, USA; Anthony Lockett MBA, MD, PhD, ICO, Leeds, W. Yorkshire, UK; Ateequr Rahman MBA, PhD, Assistant Professor, College of Pharmacy, Shenandoah University, Winchester, Virginia, USA
  Description: Studying the current environment of risk management (RM) in health care, the RM SIG identified several differences in perceptions of risk management and risk/benefit of pharmaceuticals. We also identified key discrepancies in the regulatory requirements of the Food and Drug Administration and the European Union. We will compare and contrast RM from an international perspective and open the forum for discussion of international issues regarding RM.
   
• ISPOR 11TH Annual International Meeting Short Course May 21, 2006
  Risk Assessment: Analysis and Management
  Faculty: Dennis W. Raisch, PhD, Associate Center Director, Scientific Affairs, VA Cooperative Studies Program, Clinical Research Pharmacy, Albuquerque, NM, Anthony Lockett, MD, PhD, MBA, Medical Director, ICO, Leeds, United Kingdom, Suellen Curkendall, PhD, Principal Investigator, Cerner Health Insights, Vienna, VA
  Course Description: This course will provide an overview of risk management for pharmaceuticals and devices. The risk/benefit assessment process will be described in regards to stage of product development, from pre-marketing through post-marketing. Risk mitigation includes the various strategies employed by manufacturers, regulators, and health care providers, with an emphasis on international differences in risk mitigation and decision making. Risk/benefit communication processes will be described, focusing upon how decisions regarding risk of pharmaceuticals and devices are communicated to health care providers and the public. This includes direct mailing, direct-to-consumer marketing, and labeling. Real-world exercises will allow participants to discuss key topics and propose implementation strategies for risk management. This course is designed for those with a basic understanding of pharmacoepidemiology principles.    
   
• ISPOR Risk Management Special Interest Group - A Plan for Action
  ISPOR CONNECTIONS Vol. 11 No5: October 15, 2005 https://www.ispor.org/news/articles/oct05/RMSiG.asp
   
• ISPOR 10th Annual International Meeting Workshops, May 8, 2005
  Balancing Risks and Benefits of Healthcare Treatments in the 21st Century
  
  The workshop explored and commented on the areas of risk/benefit assessment, offering interesting material on how to balance the two. A fascinating and interactive group case study was also performed following the presentation. 
  Speakers: Dennis Raisch BS, MS, PhD, RPh (SIG Chair), Associate Center Director, Scientific Affairs, VA Cooperative Studies Program, Albuquerque, NM, USA; Larry Liu MD, PhD (Co-chair, Risk/Benefit Assessment Working Group), Director, Pfizer Global Pharmaceuticals, New York, NY, USA; Paul Stang MS, PhD (Co-chair, Intervention/Implementation, Communication Working Groups), Executive Vice-President, Galt Associates, Inc. and West Chester University, Blue Bell, PA, USA; Ateequr Rahman MBA, PhD (Co-chair, Communication Working Group), Assistant Professor, Shenandoah University, Winchester, VA, USA; Anthony Lockett MBA, MD, PhD (Co-chair, Intervention/Implementation Working Group), Medical Director, ICO, Leeds, West Yorkshire, UK; Nicholas Lipskiy MBA, PhD (Co-chair, Identification Working Group), Epidemiologist,  National Center for Injury Prevention and Control, Div. of Violence Prevention, Etioloy and Surv. Branch, Atlanta, GA, USA; and Suellen Curkendall PhD, Principal Investigator, Cerner Health Insights, Vienna, VA, USA. 
  
  ISPOR Member Perspectives: How Do Individuals Perceive Risks and Benefits of Pharmaceuticals in Comparison with Other Non-Medical Activities
   
  This workshop exposed and analyzed the results of a health care survey conducted within the ISPOR membership by the Risk Management Special Interest Group. Interesting findings included: US v. non-US comparisons of risk assessment, the rate of effect individual experiences with side-effects had on the perception of pharmaceutical risk, and others. 
  Speakers: Dennis Raisch BS, MS, PhD, RPh (SIG Chair), Associate Center Director, Scientific Affairs, VA Cooperative Studies Program, Albuquerque, NM, USA; Larry Liu MD, PhD (Co-chair, Risk/Benefit Assessment Working Group), Director, Pfizer Global Pharmaceuticals, New York, NY, USA; Paul Stang MS, PhD (Co-chair, Intervention/Implementation, Communication Working Groups), Executive Vice-President, Galt Associates, Inc. and West Chester University, Blue Bell, PA, USA; Ateequr Rahman MBA, PhD (Co-chair, Communication Working Group), Assistant Professor, Shenandoah University, Winchester, VA, USA; Anthony Lockett MBA, MD, PhD (Co-chair, Intervention/Implementation Working Group), Medical Director, ICO, Leeds, West Yorkshire, UK; and Nicholas Lipskiy MBA, PhD (Co-chair, Identification Working Group), Epidemiologist,  National Center for Injury Prevention and Control, Div. of Violence Prevention, Etioloy and Surv. Branch, Atlanta, GA, USA.
   
• ISPOR 6th Annual European Congress Forum presentations, November 2003
  Exploring Risk Assessment in the Development of Pharmaceuticals in Europe 
  
  Moderator and Speaker: Anthony Lockett, PhD, MD, DMS, Director, Product Services, Covance, Leeds, West Yorkshire, UK and ISPOR Risk Management Special Interest Group member
  Speaker: Peter Davey MD, FRCP, Head of Pharmacoeconomics, University of Dundee, Department of Clinical Pharmacology, Ninewells Hospital & Medical School, Dundee, Scotland
  Speakers will discuss risk assessment in developing & marketing pharmaceuticals in Europe. In addition, the role of outcomes research in product risk assessment in Europe will be discussed. A practicing clinician’s viewpoint as well as formal risk assessment framework for pharmaceuticals and the role of outcomes research will be presented.
   
• ISPOR 8th Annual International Meeting Issues Panel, May 2003
  Looking for Signals and Targeting Interventions
  
  Chairs: Louis Morris PhD, President, Louis A. Morris & Associates, Dix Hills, NY, USA; Eva Lydick PhD, Director of Epidemiology, AstraZeneca Inc, Wilmington, DE, USA
  Panelists: John Urquhart, MD, FRCPE, Professor of Pharmacoepidemiology, Maastricht University, Maastricht NL; Judith Jones MD, PhD, President and CEO, The Degge Group, Arlington, VA, USA
  
  Outcomes research may have an important, yet unrecognized, role in product safety and risk management. This session will explore the use of outcomes research to aid in reviewing the safety and approvality of prescription drugs. Certain outcome measures may directly demonstrate the merits of product benefits better than traditional clinical measures. These outcome measures also may make risks and benefits of pharmaceuticals more directly comparable and may make it easier for regulators to make decisions about product approval.
  Outcomes research may also be used to evaluate the effects of risk management plan implementation. By focusing on outcomes of value to patients, the underlying influence of risk management plans may be assessed. The panel will explore how outcomes research may be useful in these various phases of product approval and risk management 
   
• ISPOR 8th Annual International Meeting Forum presentation, May 2003
  During this forum, the three FDA risk management concept papers are discussed.
  
  “FDA Concept Paper: Pre-marketing Risk Assessment” at: http://www.fda.gov/cder/meeting/riskManageI.htm.
  This concept paper presents FDA's preliminary thoughts on: important risk assessment concepts, generation and acquisition of safety data during product development, analysis and presentation of safety data in an application for approval.
  
  “FDA Concept Paper: Risk Management Programs”  at: http://www.fda.gov/cder/meeting/riskManageII.htm.
  This concept paper presents FDA's preliminary thoughts on: considerations for initiating and designing a risk management program, the selection and development of risk management tools, the evaluation of risk management programs, the recommended elements of a risk management program submissions.
  
  “FDA Concept Paper: Risk Assessment of Observational Data: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment”  at: http://www.fda.gov/cder/meeting/riskManageIII.htm.
  This concept paper presents FDA's preliminary thoughts on: important pharmacovigilance concepts, safety signal identification, pharmacoepidemiologic assessment and interpretation of safety signals, the development of pharmacovigilance plans. 
   
• FDA Risk Management Public Workshop, April 10, 2003
  ISPOR Comments on FDA Risk Management Concept paper FDA hearing letter
   
  » FDA Risk Management Concept Paper
  » DA Risk Management Workshop announcement