Transform the most important matters leading to FDA applications into a realistic dialogue format! Develop practical English expression skills that can be applied in real work situations.
"Global Development and Applications" is a practical English training program designed around the simulation of new drug development in the United States, covering the process from non-clinical studies to clinical trials and submitting applications to the FDA. In the development of new drugs, key aspects leading to FDA applications in the U.S., such as "non-clinical trials," "clinical trials," "applications," and "eCTD," are clearly summarized in a unique text presented in a realistic dialogue format. Please utilize this program to enhance your global responsiveness through the development of specialized English skills. 【Features】 ■ Utilizes a unique text summarized in a realistic dialogue format for easy understanding ■ Cultivates English expression skills that can be immediately applied in practice ■ Taught by native instructors with expertise and experience in fields such as pharmacy ■ Custom-made materials can be developed and implemented as unique case studies *For more details, please refer to the PDF document or feel free to contact us.
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【Content (Partial)】 ■Book1 ・Lesson 1: Major Processes in New Drug Development ・Lesson 2: Chemical/Pharmaceutical Data Required for New Drug Applications ・Lesson 3: Types of Animal Experiments ・Lesson 4: Long-term Animal Experiments Required for Applications ■Book2 ・Lesson 1: Clinical Trials Required for Applications ・Lesson 2: New Drug Applications ・Lesson 3: Electronic Applications Part I ・Lesson 4: Electronic Applications Part II *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 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.