Sign for Notice Everyday    Sign Up| Sign In| Link|

Our Sponsors

    Receive Latest News

    Share Us

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

    View: 109

    Website | Edit Freely


    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.
    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.