Pharmacovigilance System Master File (PSMF) - A Practical Approach to Design and Implementation Globally
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Deadline: April 12, 2020 | Date: April 22, 2020-April 23, 2020
Venue/Country: San Francisco, CA, U.S.A
Updated: 2020-02-11 17:36:26 (GMT+9)
Call For Papers - CFP
The pharmacovigilance system master file (PSMF) is up-to-date comprehensive and dynamic document providing company employees (including regional or local Qualified Person for Pharmacovigilance, PV auditors etc) and the regulators with a detailed description of the entire PV system.The PSMF has been a mandatory legal requirement for any medicinal product authorized in the European Union (EU) since 2012. However, in the most recent years, complexity and lack of harmonization has increased by some European (EU) and non-EU regulators requiring a local PSMF, additional PV System Annex/ Supplement/ Sub-File or completely separate PSMF specific to a region. Understanding global legal requirements in regard to PSMF, importance of PSMF within organization and common inspection findings and pitfalls relating to PSMF, can assist companies to develop sustainable quality management system for PSMF maintenance.Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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