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Japanese Journal of Pharmacoepidemiology ; : 14-16, 2015.
Article in Japanese | WPRIM | ID: wpr-376968

ABSTRACT

Based on the history of pharmacovigilance activities in Japan, the expectations for MIHARI Project from the perspective of academia are discussed. First, drug safety and risk-benefit related activities should be enhanced from the early stage of drug development and/or in the regulatory approval stage. Second, more collaboration with regulatory authorities and academia should be promoted. Third, knowledge obtained from MIHARI Project should be published timely and continuously which contribute to related safety activities conducted by other than regulators.

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