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The Risk-Based Approach to Pharmacovigilance Audits - A Practical Approach to Design and Implementation

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Website https://www.complianceonline.com/pharmacovigilance-pv-audit-gvp-sdea-sop-seminar-training-80304SEM-p | Edit Freely

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Deadline: April 10, 2020 | Date: April 20, 2020-April 21, 2020

Venue/Country: San Francisco, CA, U.S.A

Updated: 2020-02-11 17:30:38 (GMT+9)

Call For Papers - CFP

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 has to cover all PV processes and tasks undertaken by or delegated to other departments, Marketing Authorization Holder affiliates, and third parties such as distributors, external service providers, licensing partners. In other words, has to cover all PV Universe. The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule. Using risk-based approach to develop an audit strategy, companies can conform to the regulatory requirements and business needs. But the questions remain: How to do it? Where to start? How to improve? What are the best industry practices?

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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