Learn about Japan's pharmaceutical regulations and circumstances in English! Develop practical expression skills through various practice problems.
In "Japanese Pharmaceutical Affairs," we explain Japan's pharmaceutical regulations in light of global developments such as mergers and partnerships with overseas pharmaceutical companies, global development, overseas production, and import/export. We aim to cultivate practical English communication skills to enhance understanding. The unique circumstances and systems specific to Japan are clearly summarized in a realistic dialogue format based on two themes: "Pharmaceutical Affairs Related to Pre-Approval" and "Pharmaceutical Affairs Related to Post-Marketing." Please make use of this program to strengthen your global responsiveness through the development of specialized English skills. 【Features】 ■ Enhancement of specialized terminology and vocabulary ■ Development of applied expression skills through various practice exercises ■ Native teachers with expertise and experience in research and development ■ Possibility to practice presentations based on your company's materials *For more details, please refer to the PDF document or feel free to contact us.
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**Content (Partial)** ■Lesson 1: Pharmaceutical Regulations Regarding Pre-Approval in Japan - Organization and Role of PMDA - PMDA Consultation - Bridging Studies - Submission of Electronic Data and Validation at the Time of Approval Application ■Lesson 2: Pharmaceutical Regulations Regarding Post-Marketing in Japan - Drug Pricing System in Japan - Certification of Foreign Manufacturers - Risk Management Plan (RMP) - Post-Marketing Surveillance (EPPV) and Re-examination Organizations *For more details, please refer to the PDF document or feel free to contact us.*
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For more details, please refer to the PDF document or feel free to contact us.
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Our company has been planning and operating global human resource development training for businesses for 54 years. We have provided training programs to over 5,000 companies, government agencies, and local authorities, receiving positive feedback. The features of our training are as follows: 1. Training programs and approaches tailored to the needs of specific industries and departments. 2. Programs that cultivate global communication skills using industry-specific terminology. 3. Instruction that takes into account differences in communication styles that may pose problems across cultures, not just language acquisition. 4. Customized training planning based on careful listening to the challenges and requests of each company and department, rather than using pre-existing programs. 5. Instruction by instructors (both Japanese and foreign) according to the level of participants and the content of the training. 6. Development of practical global communication skills that cannot be obtained through general language training. 7. Utilization of a target skill checklist with clearly defined skill achievement goals. 8. Support for both online and face-to-face training (conditions apply). 9. Comprehensive guidance on effective self-study methods and follow-up. 10. Development of unique business simulation materials tailored to your company. We encourage you to consider our training services for the development of your global human resources and the enhancement of your global responsiveness.
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