10th DIA FDA IND/NDA Training Course in Japan(NDA only)
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(This course is NDA only.)
Click here to view the Program.
The process of new drug development has become increasingly global with companies now conducting multinational clinical studies and aiming for simultaneous submission of New Drug Applications (NDAs) in Japan, the US, the EU, China and beyond. The globalization of the pharmaceutical industry means it is now essential for professionals in the field to understand regulations, processes, and trends across the world. Delivered by expert faculty, 10th DIA FDA IND/NDA Training Course in Japan helps build understanding of FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.
Features of the Course:
• A focused look at the regulations and processes in IND/NDA including the impact of the COVID 19 pandemic.
• Guidance on how to work productively and efficiently with FDA.
• 9 hours’ of training materials* delivered on-demand and available to view for 3 months. The on-demand format enables you to move through the course at your own pace.
• The slides for each session will also be shared with participants.
• Live Q&A sessions with the course trainers (including the new ways to do under impact of the COVID 19 pandemic).
Who Should Attend?
This training will benefit regulatory and clinical development professionals who are planning US submissions and clinical trials or similar projects.
At the conclusion of this course, participants should be able to:
•Understand the impact of the COVID-19 pandemic on FDA activities and interactions with industry
•Explain the importance of incorporating regulatory strategy into the drug development plan
•Recognize content and format requirements for INDs/NDAs
•Communicate the requirements for submitting INDs/NDAs and amendments and supplements
•Describe the FDA review processes for evaluating INDs/NDAs
•Define NDA post-approval responsibilities and requirements
•Identify regulatory programs and mechanisms that can facilitate and expedite new drug development
•State how to report adverse events in accordance with current FDA pre-marketing and post-marketing regulations
•Apply sound meeting practices and productive dialogue principles when interacting with the FDA
•Outline the regulatory requirements for prescription drug labeling and advertising
*Training materials will comprise those used for the 2020 course together with some new content.
Who should attend?
Yasuyuki Hattori • Regulatory Affairs & Planning Group, New Drug Regulatory Affairs Department
Daiichi Sankyo Co., Ltd., Japan
Masayoshi Higuchi • Head of Quality & Regulatory Compliance Unit,
Chugai Pharmaceutical Co., Ltd., Japan
Akiko Ikeda, RPh • Associate Director, Regulatory Development Dept.
Janssen Pharmaceutical K.K., Japan
Miyuki Kaneko • Japan Regulatory Portfolio Lead, Regulatory Affairs
Pfizer R&D Japan G.K., Japan
Yomei Matsuoka, MSc, RPh • Vice President, Pharmacoepidemiology and PMS Department
Daiichi Sankyo Co., Ltd., Japan
Miwa Tamada • Manager, New Drug RA Department, Regulatory Affairs
GlaxoSmithKline K.K., Japan