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  6. Supplementary Material "Pharmaceutical Inspection Response Guidebook"

Supplementary Material "Pharmaceutical Inspection Response Guidebook"

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last updated:Aug 02, 2023

インターナショナルエジュケーションサービス 東京本社
インターナショナルエジュケーションサービス 東京本社
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Improve practical response skills through simulation role-playing and discussions!

In the "Inspection Response Guidebook," you will acquire practical English skills, manners, and effective response methods for inspection responses. You will be able to comprehensively understand various specialized English expressions for responding to inspections by authorities such as the FDA and EMA, as well as effective inspection response methods and manners. In-class training can include more practical exercises, utilizing your company's specific pharmaceutical materials and on-site practice in addition to this teaching material. [Contents] ■ I. Key Points of Inspection Response ■ II. Confirmation of Specialized Vocabulary ■ III. Specialized Vocabulary Exercises ■ IV. Role-Play Activities *For more details, please refer to the PDF materials or feel free to contact us.

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Supplementary Material "Pharmaceutical Inspection Response Guidebook"

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【Content Details】 ■I. Key Points for Inspection Response - Overview of considerations by authorities such as FDA and EMA - Procedures before the authority's considerations - Areas of interest for inspectors - Appropriate communication etiquette with inspectors from FDA/EMA, etc. - Consideration checklist ■II. Confirmation of Specialized Vocabulary ■III. Specialized Vocabulary Exercises ■IV. Role-Play Activities - Quality Assurance-related role play - Drug Safety Monitoring-related role play *For more details, please refer to the PDF document or feel free to contact us.

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Pharmaceutical Inspection Response Guidebook (English)

Pharmaceutical Inspection Response Guidebook (English)

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インターナショナルエジュケーションサービス

インターナショナルエジュケーションサービス 東京本社

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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.

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