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Please select the level of the material
There are materials for each level from No.1 to No.36.
No.1
Pre-submission Meeting for New Drug Approval / 新薬承認申請の事前相談
No.2
Regulatory Alignment for Global Clinical Trials / 国際共同治験の規制要件調整
No.3
【共通教材】『超実用的！万能9表現マスター』 / 9 Essential Phrases for Any Business Situation
No.4
Response to Regulatory Deficiency Letter / 承認申請書類の不備指摘対応
No.5
Post-Approval Change Management / 薬事承認取得後の変更管理
No.6
Regulatory Strategy Meeting with Global Partners / 海外パートナーとの薬事戦略会議
No.7
Preparation for Regulatory Authority Inspection / 規制当局査察への対応準備
No.8
International Harmonization of Adverse Event Reporting / 副作用報告の国際調和
No.9
Approval Strategy for New Indication Addition / 新規適応症追加の承認戦略
No.10
Regulatory Response to Generic Drug Competition / ジェネリック医薬品対策の規制対応
No.11
International Transfer of Marketing Authorization / 製造販売承認の国際移管
No.12
Submission of Clinical Trial Data to Regulatory Authorities / 臨床試験データの規制当局提出
No.13
International Coordination of Risk Management Plan / 医薬品リスク管理計画の国際調整
No.14
Progress Report on Post-Approval Commitments / 承認条件の履行状況報告
No.15
Response to International Guideline Revisions / 国際ガイドライン改訂への対応
No.16
Application for Orphan Drug Designation / 希少疾病用医薬品指定の申請
No.17
Regulatory Impact Assessment for Manufacturing Site Change / 製造施設変更の規制影響評価
No.18
Strategy for Pricing and Reimbursement Systems / 薬価・償還制度への対応戦略
No.19
Contract Negotiation with Clinical Trial Sites / 臨床試験実施医療機関との契約調整
No.20
International Coordination of Drug Labeling and Package Insert / 医薬品表示・添付文書の国際調整
No.21
Strategy for Utilizing Regulatory Science Advice / 規制科学的助言の活用戦略
No.22
Preparation of Periodic Safety Update Report / 医薬品安全性最新報告書の作成
No.23
【共通教材】言葉に詰まったときのテクニック / Fillers
No.24
【共通教材】便利な切り出し表現 / Useful Phrases to Start Your Points Clearly
No.25
【共通教材】便利なつなぎ 言葉 / Helpful Transition Phrases
No.26
【共通教材】できる限り簡単な表現で話すテクニック / Techniques for Speaking as Simply as Possible
No.27
【共通教材】日本語から直訳して話すためのテクニック / Techniques for Speaking by Translating Directly from Japanese
No.28
Comparability Assessment for Biopharmaceuticals / バイオ医薬品の同等性・同質性評価
No.29
Development of Pediatric Investigation Plan / 小児用医薬品開発計画の策定
No.30
Regulatory Approach for Drug-Device Combination Products / 医療機器併用薬の規制対応
No.31
International Management of Post-Marketing Surveillance / 製造販売後調査の国際実施管理
No.32
Regulatory Strategy Response to Competitor Patents / 競合他社特許への規制戦略対応
No.33
Preparation for Scientific Discussion with Regulatory Authorities / 規制当局との科学的議論の準備
No.34
Emergency Response for Drug Supply Shortage / 医薬品供給不足時の緊急対応
No.35
Regulatory Adaptation for Digital Health Technologies / デジタルヘルス技術の規制適応
No.36
Integrated Global Regulatory Strategy Development / 国際薬事規制の統合戦略立案
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