SJ Pharma Consulting Mendham
pharmacovigilance audit, PV audit
07945 Mendham
United States
Website: http://sjpharmaco.com/pv_auditing.html
Address: 270 Mountainside Road Mendham, NJ 07945
Phone: 973-543-4252
Pharmacovigilance audits are available from SJ Pharma Consulting in Mendham, NJ. SJ Pharma provides drug safety and pharmacovigilance training courses that cover all USA, EU, and ICH regulatory requirements. Our pharmacovigilance audit will go deeply into implementation of data mining and signal detection as part of your pharmacovigilance operations. Signal detection is mandatory in Europe and highly recommended in the US. This PV audit will also detail signal assessment, use of signal triage algorithms, compliance with EMA and FDA guidance on the matter, and GVP Module IX. Attendees of the pharmacovigilance training will also learn the components of both the EU Risk Management Plan and the FDA's Risk Evaluation and Mitigation Strategies. Contact SJ Pharma today for more information on our pharmacovigilance auditing.
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