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Japan’s Pharmaceutical Regulatory Environment: What Will the New Sakigake Pathway Mean for Drugmakers?
Japan is encouraging pharmaceutical companies to get new products approved first there, or at the very least, parallel to the US and EU, with it’s new “Sakigake” expedited pathway. Started in April, the pathway is similar to the FDA’s breakthrough designation — potentially cutting approval time in half.
The rewards for doing business in Japan can be high, but so can the stakes. The country’s regulators, long notorious for their opacity, have made efforts to foster much greater openness.
But they still don’t hesitate to wield their authority. Earlier this year, they forced a major international drugmaker to shut down its Japanese operations — production and sales — for 15 days as a penalty for failing to report side effects properly.
Alberto Grignolo shares the in-depth knowledge gained during his establishment of PAREXEL’s Japan Consulting Services. You’ll learn how the steps, priorities and expectations will differ when you meet with Japanese regulators.
If you’re going to bring your drugs to this massive market, you need this information to prepare for its unique challenges.
Alberto Grignolo, Corporate Vice President, PAREXEL
A 23-year veteran of PAREXEL, he has most recently established the firm’s Japan Consulting Services during a two-year assignment in Tokyo (2011-2013). He advises clients in the areas of global drug development strategy, and is currently engaged in initiatives that address significant opportunities and challenges in product development and commercialization. A native European, he has also lived in Latin America and Japan, and has been a frequent speaker, program chair, session chair or instructor at more than 120 international conferences, seminars, workshops and courses on drug development and regulatory affairs.
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