今年的藥物安全系列課程來啦‼️ 熱騰騰的消息小編趕快告訴大家👍 機會難得千萬要把握呀‼️
2019/12/3 (二)【藥物安全系列 】-新藥臨床開發及上市後之國際藥物安全監視實務
【Drug Safety Series 】- International Pharmacovigilance Practices from New Drug Clinical Development to Post-Marketing
報名方式On-line Registration :
https://slbiotech.pse.is/MN8XA
主辦單位：台灣光鹽生物科技學苑Taiwan Salt and Light Biotech Institute
課程地點：光鹽會議中心Salt and Light Conference Center
課程日期：108年12月3日(二) 3rd Dec. 2019 (Tue.) 09:00-17:00
☆議程大綱Topics
一、國際安全監視查核/稽核實務International Pharmacovigilance Audits/Inspections
1.如何進行國際藥物安全監視查核/稽核前準備(英文授課) Preparation prior to the audit/inspection (Dr. Meik Helmut Behrens)
2.國際藥物安全查核/稽核之應對(英文授課) Reception/reaction during audit/inspection (Dr. Meik Helmut Behrens)
3.藥物安全查核/稽核之應對演練(中英文進行)audit/inspection role-plays -稽/查核員、被訪談人、第三者觀察員 (伍亮霓召集人-Liang-Ni Wu)
4.國際藥物安全查核/稽核缺失處置與追蹤 (英文授課) Management and follow-up of the findings (Dr. Meik Helmut Behrens)
二、藥物安全數據資料庫(英文授課) Safety database (Dr. Meik Helmut Behrens)
三、新藥開發合作廠商之臨床試驗藥物安全數據交換要求(英文授課) Safety data exchange requirements in clinical trials for clinical development partnership (伍亮霓召集人-Liang-Ni Wu)
四、Panel Discussion (中文進行)：
台灣藥物安全之法規層面與執行層面如何與國際接軌
How do the Taiwanese health authority and industry regulate and execute
pharmacovigilance/drug safety in line with international standards
The experts will discuss from the below perspectives:
o 從衛生主管機關執行單位的角度Taiwanese health authority/agency
o 從台灣生技藥業進行新藥開發臨床試驗的角度Taiwanese biotech/pharma companies conducting new drug development clinical trials
o 從與國際藥廠合作之台灣代理經銷商的角度Taiwanese distributors/ sales agents for international pharma companies
o 從國際藥廠的角度International pharma company
*Panel Discussion 與談人：台灣光鹽生技學苑 蔡佩珊執行長、財團法人藥害救濟基金會藥物安全組 黃薇伊組長、安成生物科技股份有限公司臨床研究處 林宜瑩處長、台灣光鹽生技學苑國際合作組 伍亮霓召集人Liang-Ni Wu
☆講師Speakers：
*Dr. Meik Helmut Behrens (來自德國任職於國際藥廠之藥物安全專家)
Pharmacovigilance Expert from Germany, with more than 13years of industrial experience of global drug safety /pharmacovigilance within a pharmaceutical company and contract research organization.
*伍亮霓Liang-Ni Wu(任職德國國際藥廠之藥物安全專家,台灣光鹽生技學苑國際合作組)
Pharmacovigilance Alliance Manager from Taiwan (based in Germany), with 6 years of industrial experience in medical writing / regulatory affairs and 10years of drug safety/ pharmacovigilance experience within a pharmaceutical company and contract research organizations.
課程費用Registration Fee: 4500 NT/person( Lunch and coffee/tea breaks included in registration fee)
學苑信箱：bioschool@biotech-edu.com 學苑電話：02-2545-9721
