Search Results for Pharmacovigilance Inspections

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EMA Reports Rise in Pharmacovigilance Inspections in 2016 By Michael Mezher - Published 08 August 2017

In a report released on Tuesday, the European Medicines Agency (EMA) said the number of pharmacovigilance inspections for centrally authorized products rose in 2016, mainly driven by an increase in routine inspections carried out under national inspection programs.

Categories: News, Europe, EMA, Biologics and biotechnology, Compliance, Drugs, Postmarket surveillance

Tags: Pharmacovigilance, Pharmacovigilance Inspections

MHRA to Pilot Stand-Alone Pharmacovigilance Inspections for Contractors By Michael Mezher - Published 13 August 2015

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is considering conducting "stand-alone" inspections of companies that conduct pharmacovigilance activities on a contractual basis for drugmakers.

Categories: News, Europe, MHRA, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance, Regulatory strategy

Tags: Pharmacovigilance, inspections

UK Regulators Detail Most Common Pharmacovigilance Deficiencies in New Report By Michael Mezher - Published 30 March 2015

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has released statistics on the pharmacovigilance inspections it conducted between April 2013 and March 2014. While the figures continue a similar trend from previous years, MHRA says the impact of new EU pharmacovigilance legislation can be seen in the data.

Categories: News, Europe, MHRA, Drugs, Postmarket surveillance, Regulatory strategy

Tags: Pharmacovigilance, inspections, GPvP