Dr. Rut explores the product lifecycle and reviews the areas of pharmacovigilance focus and opportunities for improvement for each: • Clinical studies – Maximising intelligence based on limited data • New to market – Establishing safety profile • On Patent Product – License maintenance • Off Patent / OTC – Efficiency and automation

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•
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•
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•
•

3. •
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•
•
•
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4. •
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5. •
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0%
20%
40%
60%
80%
100%
Manufacturer
submitted -
Expedited
reports
Manufacturer
submitted -
Periodic
reports
Direct reports
by HCPs &
Patients
Incomplete
reports
Complete
reports

7. 2% 3% 1%
11%

8. 15%
5%
32%
4%
6%
5%
9%
12%
12%

10. In pregnancy
In this age group
In women
Because of new non-clinical data raises
safety concerns
Because the class of meds has just come under scrutiny
due to a competitor safety issue
Related to the abuse of this medicine
In real world use
In this ethnic group
In a new disease area
Because the product has just gone OTC

12. .

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•
•
•
•
•
•
•
•

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•
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17. •
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•
•

22. S
• ‘Informative Reports have
greatest impact’

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•

24. •
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27. 27