Research Quality Association (RQA) eBooks

Ipswich, United Kingdom

Comparison of Pharmacovigilance Regulations in Europe and Japan

It has been getting more important for MAHs to comprehend PV regulations and regulatory expectations in Europe and Japan since PV activities should be a global system in itself. Considering the importance of stakeholders in the European Union and Japan in producing hiqh quality medicinal products around the world and their determining role in directing drug safety regulations, it is important to compare these regulations and expectations and to clarify the different aspects of PV activities and their characteristics. Therefore, the Research Quality Association (RQA) and the Japanese Society of Quality Assurance (JSQA) initiated a joint effort in which the regulations from both continents are compared in order to bring the similarities and differences in each of the important topics for PV. This booklet reflects the similarities and differences in the form of short versions for each of the subjects, furthermore a summary table is also incorporated at the end of it on order to have a quick view of all these comparisons and the related document which has served as reference.

Contents

Additional monitoring Aggregate reporting Evaluation of Safety Data ICSR Reporting Inspections Literature Search Pharmacovigilance System Master File Post Marketing Studies QPPV Quality Management System Reference Safety Information Risk Management Plan (RMP) Safety Communication Signal detection

    Authors

    RQA Project Leader - Ana-Maria Aguirre-Arteta, F. Hoffmann-La Roche Ltd plus PV Committee members JSQA Project Leader - Genshu Nakamura, Biogen Japan Ltd plus JSQA members

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