距離報名截止期限還有:
About Course
Organizer:Taiwan Salt and Light Institute
Location:Microsoft Teams Live Webinar
【Due to intellectual property rights constraints, we are unable to provide the video recording.】
【Target Audience】
(1) Anyone who is interested in PV in US, UK and EU
(2) Anyone who has experience in working in drug safety
Course Outline
The live webinar will be conducted in English.
1. Real Example of an EU PV Inspection
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Presenting a real EU PV inspection setting
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Introducing a real standard question
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Presenting a real critical PV finding
2. EU PV Inspection Procedure
- Which EU authority will come to you?
- EU inspectors approach
- EU inspectors focus and conduct
- EU inspection report & key PV findings
- How to deal with findings
- Impact
3. ISO 9001:2015 Principles about Quality Management Systems – Auditing Standards
- ISO 9001:2015 Principles about Quality Management Systems
- International standards adopted for inspections
- Basis of each inspection: Documents and Processes
- Basis of each inspection: the Interview
- Why is a Quality Management System mandatory?
- Explanation of Good Documentation Practice
- Explanation of document life-cycle
4. Key PV Inspection Findings in the UK
- UK inspectors approach & conduct
- UK key PV findings
5. Key PV Inspection Findings in the USA
- FDA inspectors approach & conduct
- US key PV findings
- FDA inspection report
- How to deal with warning letters and findings
6. Comparison of Different PV Inspection Findings between the EU and the USA
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Comparison between rating approach
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Comparison between main areas
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Comparison between findings per area
7. Q&A Session
Course Fees & Registration Link
Course Fees:Special Price $4,800 NTD/person; Group Registration Price $4500 NTD/person for two or more participants
Speaker CV

Anika Staack
Current Position:
- 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
FAQ
一、如何報名課程?
- 填寫並送出Google報名表單。
- 進入線上繳費系統完成繳費。
- 以上步驟全數完成才視為成功報名。
二、找不到繳費連結怎麼辦?
繳費連結會出現在『報名表單送出界面』。
如果你不小心關閉報名完成頁面,或是事後才想繳費,最後卻找不到繳費連結,以下提供您幾個方式:
- 重新填寫並送出報名表單,再次獲取繳費連結。
- (建議)來信學苑bioschool@biotech-edu.com索取繳費連結。
最好的方式當然是報名+繳費動作一次完成,以防時間過太久忘記繳費而錯過報名期限。
三、公司報帳要注意些什麼?
如您需報帳,可直接於線上繳費系統中輸入公司正確統編,或您可來信學苑告知。(凡發票打抬頭統編者,視為單位/公司付費派訓,結訓證書將署名「xxx單位/公司(統編公司)及學員姓名」,敬請學員自行評估,謝謝。
**特別提醒:如您需開立公司統編及抬頭,請於開課前告知,恕不接受課後進行任何形式的異動。(如有此類異動需求,也請於課前告知並說明原因。)
四、公司報名無法於線上繳費系統作業,是否有提供其他繳費管道?
公司報名作業,如無法於本繳費系統作業者,請來信或來電本學苑洽詢。我們會提供您學苑的銀行帳號,屆時再將費用匯至該帳號,並回信告知轉出帳號末五碼,如需打統編抬頭則可一併告知,使完成報名手續。
五、如何確認有報名成功?
您會在完成繳費後數個工作日內,收到由光鹽寄出的<報名成功通知信件>,收件信箱為您報名時填寫之Email。如遲遲未收到請先至『垃圾郵件』內查找,或可聯繫學苑詢問課程通知進度。
六、報名後何時可以拿到發票及證書?
如為實體課程,發票及證書將於開課日當天發放。請在離開課程會場前,確認姓名、公司抬頭統編是否正確。
如為線上課程,電子發票將於課程結束後寄送至您報名時所留的email,請於報名時確認email正確無誤。(線上課程核發之電子證書需設防偽標記及建立專屬識別碼,程序較為複雜,如有不便煩請見諒)
如您急需開立電子發票或證書,請來信或致電學苑告知原因,我們將協助加快審查程序。
七、如果還有更多問題該怎麼辦?
歡迎於上班時間 : 週一 ~ 週五 09:00 – 18:00
透過以下方式聯繫學苑
- 來信學苑信箱 bioschool@biotech-edu.com
- 致電聯繫專人客服電話 02-2545-9721
- 透過官網「聯絡我們」功能