The Evolving Regulatory Environment in Japan (PMDA)

At DIA in June of this year, Tatsuya Kondo, Chief Executive of Pharmaceuticals and Medical Devices Agency (PMDA) gave a presentation on the future activities of the PMDA in Japan. In the presentation, Kondo discusses Japan’s “Rational Medicine”...

What’s New in the MEDDEV 2.7/1

Last year the EU saw an update to the MEDDEV 2.7/1. This 4th updated version of the guideline not only increased in magnitude, but also brings forth more strict requirements for Clinical Evaluation Reports (CER) in Europe. What does this mean for translation? In some...