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