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＜Elementary＞ Lesson No.11
International Transfer of Marketing Authorization / 製造販売承認の国際移管
０．Greetings & Ice-break (2min.)｜挨拶と導入
0-1 Greetings
Let’s practice a short small talk that you can use to greet a business partner and start building a good relationship.
講師との挨拶を兼ねて、ビジネスパートナーと信頼関係を築くための短いスモールトークを練習してみましょう。
[Tips / 会話のヒント]
・Can you hear me clearly?
私の声はクリアに聞こえますか？
・How's your day going so far?
今日はどんな一日でしたか？
・Talk about one small topic (Work, Weather, News, Hometown, Sports event, etc.)
軽い話題について話しましょう（仕事、天気、ニュース、地元、スポーツイベントなど）
0-2 Introduction
In today’s lesson, we’ll learn about the following situation. Have you ever experienced something similar?
本日のレッスンでは以下のようなシチュエーションについて学びます。同様のシチュエーションを経験したことがありますか？
- If you have experience, please tell us what it was like, what was difficult, or what you learned.
経験があれば、どんな内容だったか、難しかったことや学んだことなどを教えて下さい。
- If you don’t have experience, try to imagine yourself handling that situation in English.
What do you think would be challenging?
経験がなければ、英語でその状況に対応しているところを想像してみましょう。どんなことが難しそうですか？
Situation / シチュエーション
This involves managing regulatory procedures for transferring marketing authorization to overseas subsidiaries, coordinating documentation and responsibility structures.
製造販売承認を海外子会社に移管する際の規制手続きを管理し責任体制を調整する場面です。
1. Read (2 min)｜型を学ぶ
Let's read the following key sentences aloud!
下記の文章や単語を順番に音読しましょう！
1-1 Basic phrases
１．Let me explain the three main steps...（3つの主要なステップを説明させてください...）
２．You need to provide three key documents...（3つの重要書類を提供していただく必要があります...）
３．I understand your concern...（ご心配は理解しています...）
４．After the transfer is complete...（移管完了後は...）
５．We will provide training sessions...（トレーニングセッションを提供します...）
６．During the review period...（審査期間中は...）
７．This approach reduces the risk of...（このアプローチにより...のリスクが減ります...）
1-2 Essential words
１．prepare（準備する）
２．contact（連絡する）
３．submit（提出する）
４．approval（承認）
５．provide（提供する）
６．concern（心配）
７．handle（対応する）
８．complete（完了する）
９．reduce（減らす）
１０．review（レビューする）
2. Try (3 min)｜ロールプレイ練習
Let’s practice the role-play.
ロールプレイの練習をしましょう！
Situation / シチュエーション（Reference again）
This involves managing regulatory procedures for transferring marketing authorization to overseas subsidiaries, coordinating documentation and responsibility structures.
製造販売承認を海外子会社に移管する際の規制手続きを管理し責任体制を調整する場面です。
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
Thank you for arranging this call. We need to discuss the transfer of marketing authorization to our subsidiary. Could you explain the overall process and timeline?
（お電話の調整ありがとうございます。製造販売承認の当社子会社への移管について話し合う必要があります。全体的なプロセスとスケジュールを説明していただけますか？）
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
Understood. Let me explain the three main steps. First, we prepare the application documents including the transfer agreement. Second, we contact the regulatory authority for pre-consultation. Third, we submit the formal application and wait for approval. The entire process takes approximately 6 months.
（承知しました。3つの主要なステップを説明させてください。まず、移管契約を含む申請書類を準備します。次に、事前相談のため規制当局に連絡します。第三に、正式な申請を提出し承認を待ちます。全体のプロセスには約6か月かかります。）
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
I see. What documents do we need to prepare on our side? We want to avoid any delay in the submission.
（なるほど。当社側ではどのような書類を準備する必要がありますか？提出の遅延は避けたいと思います。）
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
You need to provide three key documents. First, the manufacturing site certificate from your local authority. Second, the quality management system records for the past 2 years. Third, the organizational chart showing your regulatory team structure. Please send these documents by the end of next month.
（3つの重要書類を提供していただく必要があります。まず、現地当局からの製造所証明書です。次に、過去2年間の品質管理システム記録です。第三に、薬事チームの体制を示す組織図です。来月末までにこれらの書類を送付してください。）
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
That timeline is quite tight for us. Also, I'm concerned about the responsibility structure after the transfer. Who will handle post-approval changes and annual reports?
（そのスケジュールは当社にとってかなり厳しいです。また、移管後の責任体制について心配しています。承認後の変更や年次報告は誰が対応しますか？）
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
I understand your concern. After the transfer is complete, your subsidiary will take full responsibility for all regulatory activities. However, our headquarters will continue to support you for the first 12 months. We will provide training sessions and review your submissions before you contact the authority. This ensures a smooth transition.
（ご心配は理解しています。移管完了後は、貴社子会社がすべての規制活動に対して完全な責任を負います。ただし、当社本社は最初の12か月間は引き続きサポートします。トレーニングセッションを提供し、当局に連絡する前に提出書類をレビューします。これにより円滑な移行が確保されます。）
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
The 12-month support period is helpful. One more question — what happens if the authority requests additional information during the review? Do we respond directly or do you handle it?
（12か月のサポート期間は助かります。もう1つ質問があります。審査中に当局が追加情報を要求した場合はどうなりますか？当社が直接対応しますか、それとも貴社が対応しますか？）
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
During the review period, we will work together on any requests from the authority. You prepare the technical content, and we review it before submission. This approach reduces the risk of rejection and helps you learn our response strategy. After approval, you will handle all communications independently.
（審査期間中は、当局からの要求に対して一緒に取り組みます。貴社が技術的内容を準備し、当社が提出前にレビューします。このアプローチにより却下のリスクが減り、当社の対応戦略を学ぶことができます。承認後は、すべてのコミュニケーションを独立して対応していただきます。）
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
That makes sense. Let me discuss the document preparation timeline with my team. Can we schedule a follow-up meeting next week to confirm our readiness?
（それは理にかなっています。書類準備のスケジュールをチームと話し合わせてください。来週、当社の準備状況を確認するためのフォローアップミーティングをスケジュールできますか？）
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
Absolutely. I will send you a meeting invitation for early next week. In the meantime, please review the draft transfer agreement I sent yesterday. If you have any questions about the responsibility structure or support period, feel free to contact me anytime.
（もちろんです。来週初めのミーティング招待状をお送りします。その間に、昨日お送りした移管契約書の草案をレビューしてください。責任体制やサポート期間について質問があれば、いつでも遠慮なくご連絡ください。）
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
Perfect. I appreciate your detailed explanation and the support plan. This gives us confidence to move forward with the transfer. I'll get back to you after our internal discussion.
（完璧です。詳細な説明とサポート計画に感謝します。これにより移管を進める自信が持てます。社内での話し合いの後、ご連絡します。）
3. Use (4 min)｜ロールプレイ & 実践（空欄補完）
Let's perform the role-play and fill in the blanks by translating the Japanese into English!
空欄の日本語を英語に訳しながら、ロールプレイを実践してみましょう！
Situation / シチュエーション（Reference again）
This involves managing regulatory procedures for transferring marketing authorization to overseas subsidiaries, coordinating documentation and responsibility structures.
製造販売承認を海外子会社に移管する際の規制手続きを管理し責任体制を調整する場面です。
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
Thank you for arranging this call. We need to discuss the transfer of marketing authorization to our subsidiary. Could you explain the overall process and timeline?
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
Understood. Let me explain the three main steps. First, we ［準備する］ the application documents including the transfer agreement. Second, we ［連絡する］ the regulatory authority for pre-consultation. Third, we ［提出する］ the formal application and wait for ［承認］. The entire process takes approximately 6 months.
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
I see. What documents do we need to prepare on our side? We want to avoid any delay in the submission.
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
You need to ［提供する］ three key documents. First, the manufacturing site certificate from your local authority. Second, the quality management system records for the past 2 years. Third, the organizational chart showing your regulatory team structure. Please send these documents by the end of next month.
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
That timeline is quite tight for us. Also, I'm concerned about the responsibility structure after the transfer. Who will handle post-approval changes and annual reports?
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
I understand your ［心配］. After the transfer is ［完了する］, your subsidiary will take full responsibility for all regulatory activities. However, our headquarters will continue to support you for the first 12 months. We will ［提供する］ training sessions and ［レビューする］ your submissions before you ［連絡する］ the authority. This ensures a smooth transition.
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
The 12-month support period is helpful. One more question — what happens if the authority requests additional information during the review? Do we respond directly or do you handle it?
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
During the ［レビューする］ period, we will work together on any requests from the authority. You ［準備する］ the technical content, and we ［レビューする］ it before submission. This approach ［減らす］ the risk of rejection and helps you learn our response strategy. After ［承認］, you will ［対応する］ all communications independently.
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
That makes sense. Let me discuss the document preparation timeline with my team. Can we schedule a follow-up meeting next week to confirm our readiness?
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
Absolutely. I will send you a meeting invitation for early next week. In the meantime, please ［レビューする］ the draft transfer agreement I sent yesterday. If you have any questions about the responsibility structure or support period, feel free to ［連絡する］ me anytime.
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
Perfect. I appreciate your detailed explanation and the support plan. This gives us confidence to move forward with the transfer. I'll get back to you after our internal discussion.
4. Challenge (7 min)｜応用実践
Let's perform the role-play and fill in the blanks by translating the Japanese into English!
空欄の日本語を英語に訳しながら、ロールプレイを実践してみましょう！
*Let's practice this part repeatedly until we can speak it smoothly.
このパートはスムーズにスピーキングできるようになるまで繰り返し練習しましょう。
Situation / シチュエーション（Reference again）
This involves managing regulatory procedures for transferring marketing authorization to overseas subsidiaries, coordinating documentation and responsibility structures.
製造販売承認を海外子会社に移管する際の規制手続きを管理し責任体制を調整する場面です。
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
Thank you for arranging this call. We need to discuss the transfer of marketing authorization to our subsidiary. Could you explain the overall process and timeline?
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
Understood. ［3つの主要なステップを説明させてください。］ First, we prepare the application documents including the transfer agreement. Second, we contact the regulatory authority for pre-consultation. Third, we submit the formal application and wait for approval. The entire process takes approximately 6 months.
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
I see. What documents do we need to prepare on our side? We want to avoid any delay in the submission.
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
［3つの重要書類を提供していただく必要があります。］ First, the manufacturing site certificate from your local authority. Second, the quality management system records for the past 2 years. Third, the organizational chart showing your regulatory team structure. Please send these documents by the end of next month.
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
That timeline is quite tight for us. Also, I'm concerned about the responsibility structure after the transfer. Who will handle post-approval changes and annual reports?
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
［ご心配は理解しています。］ ［移管完了後は、貴社子会社がすべての規制活動に対して完全な責任を負います。］ However, our headquarters will continue to support you for the first 12 months. We will provide training sessions and review your submissions before you contact the authority. This ensures a smooth transition.
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
The 12-month support period is helpful. One more question — what happens if the authority requests additional information during the review? Do we respond directly or do you handle it?
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
During the review period, we will work together on any requests from the authority. You prepare the technical content, and we review it before submission. This approach reduces the risk of rejection and helps you learn our response strategy. After approval, you will handle all communications independently.
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
That makes sense. Let me discuss the document preparation timeline with my team. Can we schedule a follow-up meeting next week to confirm our readiness?
🧑🎓【Student / Regulatory Affairs Specialist (Headquarters)】:
Absolutely. I will send you a meeting invitation for early next week. In the meantime, please review the draft transfer agreement I sent yesterday. If you have any questions about the responsibility structure or support period, feel free to contact me anytime.
👨💼【Teacher / Regulatory Affairs Manager (Subsidiary)】:
Perfect. I appreciate your detailed explanation and the support plan. This gives us confidence to move forward with the transfer. I'll get back to you after our internal discussion.
\ If you have some extra capacity, give it a try（余力があればやってみましょう）/
5. Real-world application (5 min)｜実務応用
Let's speak freely with the phrases and flow we learned today. If you can, imagine your real job—it makes practice more effective.
本日学習した単語やフレーズ、会話の流れを思い出しながら、自由に話してみましょう。可能であれば、自身の実務を想像しながら話すと効果的です。
Situation / シチュエーション
Your subsidiary is preparing to receive marketing authorization transfer from headquarters.
You need to explain your readiness and confirm the support structure with the headquarters regulatory team.
貴社子会社は本社から製造販売承認の移管を受ける準備をしています。
本社の薬事チームに対して準備状況を説明し、サポート体制を確認する必要があります。
👨💼【Teacher / Regulatory Affairs Specialist (Headquarters)】:
Thank you for joining today. Could you update me on your document preparation status and any concerns about the transfer process?
（本日はご参加ありがとうございます。書類準備の状況と移管プロセスに関する懸念事項について最新情報を教えていただけますか？）
🧑🎓【Student / Your Role】:
(Free Speaking based on today's lesson)
Hints / ヒント
１．Explain the document preparation progress（書類準備の進捗を説明する）
２．Provide the current status of required documents（必要書類の現状を提供する）
３．Describe the support structure after transfer（移管後のサポート体制を述べる）
４．Clarify the approach to reduce risks（リスクを減らすアプローチを明確にする）
※This is not a role-play. Please speak until you finish your thoughts.
このパートはロールプレイ形式ではありません。最後まで通して話してみましょう。
6. Wrap-up (2 min) ｜レッスンの振り返り
Let's review today's lesson with your teacher!
今日のレッスンについて講師と振り返ってみましょう！
6-1 Comments from student
・Good points / 良かったところ・上手くできたところ
・Things to work on / 今後強化したいところ
6-2 Feedback from teacher
・Good points / 良かった点
・Things to work on / 今後の強化ポイント
・What to review / 復習ポイント
*6-3 Questions from student (if any)
Japanese translation（日本語訳）
1. Read (2min)（型を学ぶ）｜基本フレーズ
2. Try (4min)（ロールプレイ練習）｜型を使った練習
Let’s practice the role-play.
ロールプレイの練習をしましょう！
3. Use (7min)｜応用
Let’s perform the role-play and filling in the missing English!
英語を補完しながら、ロールプレイを実践してみましょう！
4. Challenge (7min)｜実践
Let’s perform the role-play and filling in the missing English!
英語を補完しながら、ロールプレイを実践してみましょう！
5. Wrap-up (3min) – レッスンの振り返り
"Let’s review today’s lesson with your teacher!”
「今日のレッスンについて講師と振り返ってみましょう！」
5-1. Comments from Student
- Good points / 良かったところ・上手くできたところ
- Things to work on / 今後強化したいところ
5-2. Feedback from Teacher
- Good points / 良かった点
- Things to work on / 今後の強化ポイント
- What to review / 復習ポイント
5-3. Question from Students (If any)
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