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Adverse Event Reporting And Pharmaceutical
Marketing Research
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Adverse Event Reporting And You!!!
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Market Researchers Are Not Equipped To Assume
The Responsibility Or Liability Associated
With Adverse Event Reporting-And May Not
Understand The Risk
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CASRO Taskforce, Pharma Market Research
Report- January/February, 2006
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Major Survey Research Trade Organization
Cautions On Dangers Of Using Pharmaceutical
Surveys As A Component Of Pharmacovigilence
Process
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CASRO Press Release June 28, 2006
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True Today-But Needs To Change Significantly
And Quickly
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(No Transcript)
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(No Transcript)
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Principles You Need To Follow
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Make A High Level Spokesperson Available
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Accept Responsibility/ Express Compassion
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You Cant Put The Genie Back In The Bottle
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The Bank Of Goodwill
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Important Issues Include
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An Adverse Event Is...?
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An Adverse Drug Reaction?
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Lack Of Efficacy?
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Need To Titrate?
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All Of The Above?
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Current/Potential Impacts

• Less Pharmaceutical Marketing Research Being
  Conducted
• Significant Increases In Research Costs/Timing
• Biases Resulting By Avoiding AE-Evoking Questions
• Increased Recruiting Challenges

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We Need To

• Agree On A Practical Definition Of An Adverse
  Event
• Understand That Cause And Effect Are Not For The
  Marketing Research Agency To Determine
• Work Together To Develop Standard Reporting
  Policies, Mechanisms, Etc.

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We Can

• Provide Routine Guidance To Contact
  Physician or MedWatch
• Report The Event Without Patient
  Identification/Contact Information
• Request Patient Permission To Report
  Identification/Contact Information If Adverse
  Event Is Discussed
• Notify Respondents That If An Adverse Event Is
  Discussed, They May Be Contacted

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Training

• Pharmaceutical Company Provides Slides For
  Marketing Research Agency To Use In-House
• In-House Training Provided At Marketing Research
  Agency, Or At Company, By A Pharmaceutical
  Company Employee
• On-Line Training Provided By Pharmaceutical
  Company

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Pharmaceutical Marketing Research Agencies Must
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Develop Their Own Policies And Procedures For
Dealing With Adverse Events
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And Use Them To Support, Not
ToThwart, Our ClientsCompliance Efforts
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