【著作權嚴正聲明】

本線上課程內容受著作權法保護，本學苑僅授權報名並完成繳費之個人學員自我學習，同一帳號僅授權一人使用，

如超越前述範圍之使用，其他第三人或企業應另先依規定取得授權，不得自行側錄或以其他方式重製、公開播放、公開傳輸、散布，

情節嚴重者，處三年以下有期徒刑、拘役，或科或併科新臺幣七十五萬元以下罰金，敬請務必謹慎使用，以免觸法。

【購課者需知】

為維護購課者對於專業生技醫藥課程的重視程度與學習效率，故本課程在購買後具有10天的觀看時限。

溫馨提醒：購買此課程前請思考自身是否能在期限內完成學習，逾期者如欲繼續學習，煩請來信bioschool@biotech-edu.com洽詢。

【電子證書領取步驟】

【企業團體優惠】

企業團體多人觀看另有優惠價格，請洽 02-2545-9721。

【課程內容】

Part I Sourcing of Study Drug, Packaging and Labeling

Sourcing of Study Drug、Primary and Secondary Packaging、Labeling、Blinded vs. Open-Label、Storage Conditions、Distribution Logistics、Points to consider、Mini-challenge

Part II Distribution, Storage and Treatment

Local vs. Global、Impact of manufacturing、Rely on one source or multiple sources、Quality issues、Inspections and audit findings、Impact of treatment and enrollment durations、Destruction of study drug、In-between the trial、At the end of the trial、Importance of drug supply monitoring and the drug log、Subject Specific vs. IVRS/IWRS、Risk and mitigation plan、Dealing with KPIs、Coordination efforts

Part III Risk and Mitigation Strategy

Risk identification、Risk Assessment Matrix、Mitigation strategies

Part IV Dealing with KPIs and Coordination Effort

Assess and measure supply chain and operational robustness、Start collecting meaningful values、Update RAID log as necessary

【師資介紹】

Anika Staack

Current Position:

Founder of ARC-TRAICOA

EU-Qualified Person for Pharmacovigilance (EU-QPPV)

Local German QPPV Consultant and Speaker

Previous Experience:

EU-QPPV / Stufenplanbeauftragte & Group Leader PV at Medice

Senior Drug Safety Manager at ICON

Lead Site Management Associate at PRA

Clinical Research Associate at SKM Oncology

Expertise:

Expertise Databases: European Medicine Agency EudraVigilance and xEVMPD

Quality Assurance: Audits & Inspections, SOP Writing and QA documentation, recalls and product quality

Clinical Trial Management: Feasibility, monitoring, eCRF set-up, database reconciliation, site selection, contract management, patient recruitment, study reports

Authorization process: PSMF, RMP & PSUR Writing, answering authority requests, Risk Management, overseeing product life-cycle

Education Background:

Master of Science (Biology)