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[V5-S5] Educational Session: Comparison of Review Processes by PMDA/FDA/EMA - For Successful Global Simultaneous Submission
Session Chair(s)
Akiko Ikeda, RPh
PRIMO, External Researcher/Consultant
National Cancer Center, Japan
The global simultaneous drug development has become common in recent years, and it is important to develop drugs while understanding situations in Japan as well as in foreign countries. Therefore, we would like to focus on the review processes, and compare them in Japan, Europe, and the US, explaining their differences. In addition, instructors will explain the basics of consideration points for early approval based on examples of the actual reviews. We believe it is possible to achieve rapid review and early approval by understanding each review process.
Speaker(s)
Comparison of Review Processes by PMDA/FDA/EMA for Successful Global Simultaneous Submission
Masayoshi Higuchi
Chugai Pharmaceutical Co., Ltd., Japan
Head of Quality & Regulatory Compliance Unit,
Comparison of Review Processes by PMDA/FDA/EMA for Successful Global Simultaneous Submission
Miyuki Kaneko
Pfizer R&D Japan G.K., Japan
Japan Regulatory Portfolio Lead, Regulatory Affairs
Comparison of Review Processes by PMDA/FDA/EMA for Successful Global Simultaneous Submission
Sheetal Agarwal, PhD, RAC
PAREXEL Consulting, United States
Principal Consultant