ISPE Policies & Presentations

ISPE Policies

• Guidelines for Submitting Adverse Event Reports for Publication (Published in Pharmacoepidemiology & Drug Safety 2007; 16:581-587)
  
  
• Press Release ISPE Statement on Regulatory Systems to Improve Pharmaceutical Safety, February 22, 2005
  
  
• ISPE Statement on Regulatory Systems to Improve Pharmaceutical Safety — accepted February 10, 2005
  
  
• ISPE Policy Manual (For members only. Please access this from the Members Only page)

ISPE Good Pharmacoepidemiology Practices

• Guidelines for Good Pharmacoepidemiology Practices (GPP) — Amended April 2007
  Click here to access publication: Pharmacoepidemiology and Drug Safety, 2008; 17:200-208
  
  
• Data Privacy, Medical Record Confidentiality, and Research in the Interest of Public Health — Amended 19 August 1998

ISPE Responses

• ISPE Response to US Food and Drug Administration Docket No. FDA-2008-N-0234, Developing Guidance on Conducting Scientifically Sound Pharmacologic Safety Studies Using Large Electronic Data Sets; Public Workshops; Requests for Comments, submitted June 7, 2008
  
  
• ISPE Comments on US Food and Drug Administration Docket No 2007N-0005, Prescription Drug User Fee Act, submitted to FDA February 20, 2007
  
  
• ISPE Comments on 2006 CIOMS draft “Special Ethical Considerations for Epidemiologic Research” as proposed supplement to the updated 2002 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, December 12, 2006
  
  
• ISPE Response to European Commission Public Consultation: An Assessment of the Community System of Pharmacovigilance, June 29, 2006
  
  
• ISPE Response to Statement on JAMA Guidelines for Authors, November 7, 2005
  
  
• ISPE Comments on March 2005 draft of the revision of the 1991 CIOMS International Guidelines for Ethical Review of Epidemiologic Studies
  
  
• ISPE Comments on EMEA Guideline on Risk Management Systems for Medicinal Products for Human Use, submitted to EMEA on October 4, 2005
  
  
• Final ISPE Comments on FDA Draft Guidance for Industry, submitted to FDA July 2, 2004
  
  
  • Premarketing Risk Assessment
    
    
  • Development and Use of Risk Minimization Action Plans
    
    
  • Good Pharmacovigilance and Pharmacoepidemiologic Assessment
  
  
  
• ISPE Comments on FDA Guidance for Industry Pharmacogenomics Data Submission, submitted to FDA on February 3, 2004
  
  
• FINAL ISPE Responses to the FDA Concept Papers, April 9-11, 2003; submitted to FDA on May 29, 2003
  
  
• Comments on Standards for Privacy of Individually Identifiable Health Information, published in the November 3, 1999 Federal Register. Letter to Assistant Secretary for Planning and Evaluation U.S. Department of Health and Human Services, 17 February 2000

Presentations at ISPE meetings

• Brian L. Strom, FISPE, ISPE Sustained Scientific Excellence Award Address
  
  
• Sean Hennessy, FISPE, Presidential Address, August 25, 2006, Lisbon, Portugal
  
  
• Harry Guess, MD, PhD, The Role of Epidemiology in Drug Safety and Development. ISPE Sustained Scientific Excellence Award & Lecture. August 22, 2006
  
  
• Gerald A. Faich, FISPE, Presidential Address, August 2005, Nashville, Tennessee
  
  
• Susana Perez-Gutthann, FISPE, Presidential Address, August 2004, Bordeaux, France
  
  
• Presentations from Health Care Databases & Research. A Symposium on the Power and Perils of Health Data Used in Epidemiologic and Economic Research.
  April 14, 2000.
  
  
• Presentations from the SPECIAL PLENARY SESSION: GLOBAL BURDEN OF DISEASE AND DRUG POLICY: IMPLICATIONS FOR DRUG DEVELOPMENT, USE AND MONITORING, 16th ICPE, Barcelona, Spain, August 22, 2000.