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, while fostering practical English communication skills for better 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 Price 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 materials 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 develop global communication skills using industry-specific terminology. 3. Instruction that takes into account differences in communication styles 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 suited to the participants' levels and training content (both Japanese and foreign instructors). 6. Development of practical global communication skills that cannot be obtained through general language training. 7. Use of a target skill checklist with clear skill achievement goals. 8. Support for both online and in-person training (with conditions). 9. Comprehensive guidance on effective self-study methods and follow-up. 10. Development of unique business simulation materials tailored to your company. We invite you to consider our training services to enhance your company's global human resource development and global responsiveness.