PAREXEL's Alberto Grignolo, VP to Speak at DIA 2014
I am Alberto Grignolo at PAREXEL Consulting, and I am pleased to invite you to join me for the Tutorial that I will deliver on Sunday morning June 15 at the 50th Annual Meeting of DIA in San Diego. The topic will be Japan. Specifically, this third annual Tutorial will again address Japan's Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development in that large market. I am deeply honored that delivering the Tutorial with me once again will be Dr. Yoshiaki Uyama, Director of the Analysis Division in the Office of Safety I at the Pharmaceuticals and Medical Devices Agency (PMDA). Uyama-san is well known to DIA and to many other audiences, as he has represented PMDA for many years at numerous DIA events and Annual Meetings in Japan, other Asian countries, the United States and Europe. His expertise and communication skills are superb; you and I will no doubt learn a great deal from his experience and answers to your questions during this Tutorial. As I learned directly while working in Tokyo for a number of years recently, the Japanese regulatory environment has undergone a significant transformation since 2007, in a concerted effort to eliminate the so-called "drug lag" and to attract therapeutic innovations both from within and from outside Japan. In this 3.5-hour Tutorial, Uyama-san and I will describe this environment for you and will provide specific details on how to prepare for and gain access to PMDA, to the Ministry of Health, Labor and Welfare and to the market. The Tutorial will describe the major drivers of the regulatory system, regulatory procedures during drug development (such as Consultations with PMDA and Clinical Trial Notifications), the integration of Japan drug development with East Asian and global drug development, orphan drug regulation and applications, and J-NDA preparation and review. We will also cover several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements. I hope that you will join Uyama-san and me from 8:30am until 12 noon on Sunday June 15 in San Diego and that you will participate actively in our discussions. See you there!