Training Program "Pharmaceutical Regulations for New Drug Approval Applications in the United States"
Clear and easy to understand in a realistic dialogue format! You can improve your practical English skills through simulated conversations.
In "Pharmaceutical Regulations Related to 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-based simulation conversations, aiming to improve practical English communication skills. In-class training can also 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 ■ Instruction by native teachers with expertise and experience in pharmacy and related fields ■ 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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basic information
【Content (Partial)】 ■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 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.
Company information
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.