REGULATORY
Risk Management Plans to Be Required from April 2013 to Strengthen Post-Marketing Safety Measures
Starting in April 2013, the Ministry of Health, Labor and Welfare (MHLW) will require pharmaceutical manufacturers to submit drug risk management plans (RMP) including risk minimization programs when submitting new drugs and biosimilars for approval and when new safety concerns…
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REGULATORY
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A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…





