Training Program: "Pharmaceutical Regulations for New Drug Approval Applications in the United States"
Clear and easy in a realistic dialogue format! You can improve your practical English skills through simulated conversations.
In "Pharmaceutical Regulations Regarding New Drug Approval Applications in the United States," participants will learn about the pharmaceutical regulations related to new drug approval applications to the FDA through realistic dialogue simulations, aiming to improve practical English communication skills. In-class training can include presentations, discussions, and case studies based on your company's specific pharmaceutical materials in addition to this teaching material. Please make use of this opportunity 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 ■ Instructed by native teachers with expertise and experience in fields such as pharmacy ■ 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 (Part)】 ■Lesson 1: Apply for IND (Investigational New Drug Application) ■Lesson 2: Undergo review by CDER (Center for Drug Evaluation and Research, FDA) regarding the IND application ■Lesson 3: Understand the overview of NDA (New Drug Application) ■Lesson 4: Summarize responsibilities and reports related to regulations after approval *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 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.