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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”...

Rounding Out the Summer: Industry Events

As summer is quickly drawing to a close, I want to take this time to explore some of the many upcoming industry events. In such a fast-paced industry, the life sciences industries are an area that provides numerous opportunities for continued learning. Understanding...

e-Learning in the Life Sciences Industries – Best Practices

In our digitally connected world, e-Learning is being used ever more frequently as a method of information delivery. Utilized by industries around the globe, e-Learning allows for efficient and cost-effective continued learning and training opportunities. Localizing...

CFDA: The Face of Regulation in China

The China Food and Drug Administration (CFDA) was founded in 2013. Grown from the organization formally known as the State Food and Drug Administration (SFDA), the CFDA was created to combine multiple regulatory authorities into a singular regulation process for food...

Why an In-Country Review (ICR) is So Important

An in-country review (ICR), also referred to as an in-house review, is an essential step in life science translations. With translations for industries such as medical, pharmaceuticals, and biotechnologies, accuracy is of the utmost importance. Generally, in-country...

Clinical Trials in India

Several years ago, clinical trials in India were a booming business. After becoming fully compliant with TRIPS in 2005, India was seen as a favorable place to conduct clinical trials as they boast a huge genetically diverse population, as well as a multitude of...