Figure 16.1. Evolution of yearly number of all and serious reports to Regional Centres for Pharmacovigilance (CRPV) and serious reports to industry.

all (CRPV)

serious (CRPV)

serious (industry)

RESULTS In 1998 (Figure 16.1):

• The Regional Centres received 18 590 reports that were entered in the national database: 7635 (41%) were serious. Industry transmitted about the same number of serious reports to the Agency (8261 reports in 1997). m There were 32 099 requests for information,

6552 of which became reports. m 195 investigations were ongoing or initiated (systematic or alert-based), resulting in 84 reports to the Technical Committee, and 46 European Alerts. In addition, there were 78 investigations related to marketing authorisation re-evaluations for over-the-counter (OTC) switches or product information changes at the request of the MAH.

• Centre personnel taught 954 hours of initial training (medical, pharmacy or other), 957 hours of complementary training (e.g. in master-level courses), and 533 hours continuing medical education.

• There were 193 peer-reviewed publications, 193 didactic or review publications (such as this one), and 285 presentations in scientific meetings.

In 2000:

• 17 063 ADR reports (7853 serious) have been collected by the Regional Pharmacovigilance

Centres which also conducted 116 national pharmacovigilance investigations.

* 53 237 serious ADR reports have been sent by the pharmaceutical companies to the Pharmacovigilance Unit of the Agency, of which 13 845 came from France, including follow-up reports and duplicates. In addition, the Pharmacovigilance Unit received 2180 PSURs from the companies.

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