REGULATORY

ICH Reaches Agreement to Treat Subjects with Similar Ethnic Factors as Single Populations Regardless of Nationality

December 18, 2015

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The International Council for Harmonization (ICH) agreed to include an idea of “pooled populations” in its E17 Guideline (Multi-Regional Clinical Trials) at its meeting in Jacksonville, Florida, an official of the Pharmaceuticals and Medical Devices Agency (PMDA) said in a…

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Chuikyo Debate on FY2026 Drug Pricing Reform

Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

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COLUMN

The Strategic MSL: Beyond Data Delivery, It’s About Impact

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I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…

COMMENTARY

Hisamitsu’s MBO: Is Shareholder Accountability Trust-Building or a Shackle?

By Hayate Horiguchi

Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…