Vigilance Expertise: Pharmacovigilance inspection unit: A deficiency
NOVA BIOTECH-PHARM CONSULTING 13 rue Camille Desmoulins 92130 Issy Les Moulineaux France Tel : +33(0)1 58 04 27 85 Fax : +33(0)1 58 04 23 00 Mail : [email protected] Vigilance Expertise: Pharmacovigilance data management: MedDRA, ARIS, Safety-Easy and Argus coding Medical assessment (adverse event encoding, assessment of the relatedness according the French method (Begaud) and the WHO method, assessment of the expectedness and seriousness Writing case narratives Drafting periodic reports of pharmacovigilance (CSRs, DSUR/PSURs, AddCO, PGR) Regulatory dossiers audits Monitoring of scientific literature (Pubmed, Reactions, Pascal, Embase-Medline) Preparing variation applications (DMI) Drafting internal procedures Pharmacovigilance inspection unit: Prepare for a GPvP inspection Summary of Pharmacovigilance Systems (SPS) Pharmacovigilance System Master File (PSMF) Detailed Description of Pharmacovigilance Systems (DDPS) A deficiency in pharmacovigilance systems, practices or processes that adversely affects the rights, safety or well-being of patients or that poses a potential risk to public health or that represents a serious violation of applicable legislation and guidelines. Our goal is to provide expertise that fit into your strategy and contribute to your success NOVA BIOTECH-PHARM CONSULTING -13 rue Camille Desmoulins - 92130 Issy Les Moulineaux-France Tel : +33(0)1 58 04 27 85 Fax : +33(0)1 58 04 23 00-Mail : [email protected]
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