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    PV (Pharmacovigilance) Audit Strategy Planning - 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 | Want to Edit it Edit Freely

    Category

    Deadline: April 30, 2021 | Date: May 10, 2021-May 11, 2021

    Venue/Country: U.S.A

    Updated: 2021-04-02 17:52:01 (GMT+9)

    Call For Papers - CFP

    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.

    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.