光鹽生技醫藥人才圈

【課程內容】 一、專利說明書導讀與詳解 專利說明書組成與架構 如何閱讀專利說明書 如何將實驗數據轉化為適當的專利說明書 二、醫藥類專利類型與申請範圍解讀 醫藥類專利類型解析 醫藥專利之新穎性與進步性判斷 醫藥專利之充分揭露與據以實施要件 三、醫藥品專利侵權分析與迴避設計 侵權分析 a. 侵權分析準則概論 b. 案例研析 直接與間接侵權 a. 仿單內容與請求項撰寫技巧 b. Skinny labeling 四、原廠/發明人、505(b)2、學名藥申請人策略 原廠/新藥公司專利申請策略與佈局 505(b)2/學名藥申請人專利策略、迴避設計的考量 【師資介紹】 盧佳吟 經歷： 金樺生物醫學(股)公司 研發部 副研究員/智財專員 學歷： 台灣大學 法律學分班 台灣大學 微生物暨免疫學研究所 台灣大學 生化科技學系 證照： 台灣高考專利師證照 TIPA(台灣智慧財產培訓學院)智慧財產能力認證 A. 專利技術工程類 B. 專利程序控管類 C. 專利檢索分析與加值運用類

【課程內容】 FDA臨床開發情境設定說明：以糖尿病新藥為例 TPP與CDP如何讓臨床研發事半功倍？ TPP與CDP的臨床和商業意義：提問與討論 製作TPP的思維架構 TPP案例分享：提問與討論 (FDA Case Study: Drug Approval – Bringing a New Drug to The Market) 製作CDP的思維架構 CDP案例分享：提問與討論 (FDA Case Study: Drug Approval – Bringing a New Drug to The Market) 如何將TPP與CDP的思維帶入組織的研發決策？ TPP與CDP的實務運用：提問與討論 Q & A 【師資介紹】 陳昱宏 Bert Chen CMPP Cochrane Member 現職： Vercentrys Biomedical Director Vercentrys Taiwan Advisory Board, Drug Research Center, NTU Industry Consultant, Center for Biotechnology, NTU Translation Consultant, National Palace Museum Professional Experience: 2021: — TPP and CDP for new modality drug — TPP and CDP for novel cell therapy — TPP for novel anticancer small molecule drug — TPP for novel antidiabetic small molecule drug 2020: — TPP and CDP for novel anticancer monoclonal antibody — TPP and CDP for novel antirheumatic monoclonal antibody — TPP for novel anticancer small molecule drug 2019: — TPP and CDP for rheumatoid arthritis biosimilar — TPP for novel lung cancer imaging technique Certification: Certified Medical Publication Professional, International Society for Medical Publication Professionals (ISMPP) Accredited Chinese-English Translator, Ministry of Education N1 Japanese Language Proficiency Certificate Awards: 2020 Gold Award for Patient Education Booklet, Health Promotion Administration of the Ministry of Health and Welfare 2019 Silver Award for Patient Education Booklet, Health Promotion Administration of the Ministry of Health and Welfare

【課程內容】 一、講師背景介紹及其實務經驗分享 二、臨床試驗之發展 三、臨床試驗相關產業類別 四、臨床試驗參與之角色及職責 五、藥品優良臨床試驗作業準則 (Good Clinical Practice,GCP) 概論 (1) GCP沿革與章節介紹 (2) 第一章：總則 (3) 第二章：受試者保護 (4) 第三章：人體試驗委員會 (5) 第四章：試驗主持人 (6) 第五章：試驗委託者 (7) 第六章：臨床試驗之申請與審查 (8) 第七章：臨床試驗之進行 (9) 第八章：附則 【師資介紹】 張瑞雲 主要經歷： 祈瑞新藥開發股份有限公司 臨床營運部 經理 台大醫院國家級臨床試驗與研究中心 SMO經理 佳正國際顧問股份有限公司 台灣區臨床試驗執行部 經理 佳生科技顧問股份有限公司 臨床研究經理、專案經理 國立臺灣大學附設醫院 護理師

【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)