Category Archives: Pharmacovigilance
TGA Inspections are Coming – Is your Company Ready?
The TGA has recently concluded its pilot program in Pharmacovigilance inspections in Australia. Numerous companies volunteered to take part in this inspection program, and from those volunteers the TGA selected ten companies. The selection process by the TGA considered a) … Continue reading
Posted in Medical Services, Pharmacovigilance, TGA
Tagged Inspections, Pharmacovigilance, TGA
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Proposed updates to GVP Module VI and what this might mean for our clients
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. The … Continue reading
Posted in Life Sciences Industry, Pharmacovigilance, TGA
Tagged European Medicines Agency, GVP, Medsafe, TGA
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