臨床試驗系列課程

Drug supply and Logistics in Multi-national Trials(2小時30分鐘)

NT$4,500
課程分享
收藏人數
0
章節數目
4
課程時長
2h 26m 02s
下架日:無
購課後可觀看10天
NT$4,500
課程公告

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課程簡介

【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)


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