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Xiamen, China, China
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rome, Italy
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Kyoto, Japan

Nov
18

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

 
 Conference CFP

When:

  18 Nov 2021 through 19 Nov 2021

CFP Deadline:

  18 Nov 2021

Where:

  Online Event | United States

Website URL:

  https://www.complianceonline.com/pharmacovigilance-pv-audit-gvp-sdea-sop-seminar-training-80304SEM-prdsm?channel=Brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Medicine & Health - Medical-Speciality

Keywords:


Event description:

The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule. In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. Th... Read more

Posting date:

26 October 2021  |  257 views

Placement:

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